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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00162266
Registration number
NCT00162266
Ethics application status
Date submitted
9/09/2005
Date registered
13/09/2005
Date last updated
1/06/2012
Titles & IDs
Public title
Abatacept With Methotrexate- Phase IIB
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Scientific title
A Phase IIB, Multi-Center, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Safety and Clinical Efficacy of Two Different Doses of BMS-188667 Administered Intravenously to Subjects With Active Rheumatoid Arthritis While Receiving Methotrexate
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Secondary ID [1]
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IM101-100
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Inflammatory and Immune System
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Rheumatoid arthritis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Abatacept (BMS-188667)
Treatment: Drugs - Abatacept (BMS-188667)
Treatment: Drugs - Abatacept (BMS-188667)
Treatment: Drugs - Placebo
Experimental: Abatacept (10 mg/Kg) - Open Label -
Experimental: Abatacept (2 mg/kg) - Double blind -
Experimental: Abatacept (10 mg/kg) - Double blind -
Experimental: Placebo - Double blind -
Treatment: Drugs: Abatacept (BMS-188667)
IV, 10 mg/Kg, monthly, for the duration of the trial
Treatment: Drugs: Abatacept (BMS-188667)
Intravenous (IV) infusion, 2 mg/kg, infused intravenously for approximately 30 min, infusions on Days 1, 15, 30 and monthly thereafter for 12 months
Treatment: Drugs: Abatacept (BMS-188667)
Intravenous (IV) infusion, 10 mg/kg, infused intravenously for approximately 30 min, infusions on Days 1, 15, 30 and monthly thereafter for 12 months
Treatment: Drugs: Placebo
Intravenous (IV) infusion, 0 mg/kg, infused intravenously for approximately 30 min, infusions on Days 1, 15, 30 and monthly thereafter for 12 months
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Responders to American College of Rheumatology 20% Improvement Criteria (ACR 20) at Day 180 of the Double-Blind (DB) Period
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Assessment method [1]
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ACR 20 response requires a participant to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in Health Assessment Questionnaire score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits.
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Timepoint [1]
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Day 180
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Primary outcome [2]
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Participants Receiving Concomitant Disease Modifying Rheumatic Drugs and Biologics in Open-Label (OL) Period
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Assessment method [2]
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The number of participants receiving concomitant rheumatoid arthritis treatment with disease modifying rheumatic drugs and/or biologics.
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Timepoint [2]
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Day 360 to Day 3,060
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Primary outcome [3]
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Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) in OL Period
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Assessment method [3]
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AE=any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with treatment.SAE=any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Related AE/SAE=Certain,Probable,Possible,or Missing relationship to drug.
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Timepoint [3]
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Day 360 to Day 3060
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Primary outcome [4]
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Number of Participants With AEs of Special Interest in OL Period
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Assessment method [4]
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AEs were defined as any new untoward medical occurrence or worsening of a pre- existing medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest were those which may be associated with the use of immunomodulatory agents or infusion of therapeutic proteins. Acute infusional AEs were defined as those that occurred within 1 hour after the start of the infusion. Peri-Infusional AEs were defined as those that occurred within 24 hours after the start of the infusion.
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Timepoint [4]
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Day 360 to Day 3060
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Primary outcome [5]
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Baseline Serum Immunoglobulin A (IgA) Over Time in OL Period
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Assessment method [5]
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Time-matched baseline (Day 0) values and post-baseline values were presented for each post-baseline visit and represent only that cohort of participants with measurements available at that post-baseline assessment. Mean Change from Baseline data for these cohorts are presented in Outcome Measure 6.
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Timepoint [5]
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Baseline (Day 0) and Days 360, 720,1080, 1440, and 1800
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Primary outcome [6]
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Mean Change From Baseline (BL) in IgA Over Time in OL Period
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Assessment method [6]
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Blood samples for immunoglobulin assessments were obtained to determine change from baseline in serum IgA. Baseline data for these time-matched cohorts are presented in Outcome Measure 5.
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Timepoint [6]
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Baseline (Day 0) and Days 360, 720, 1080, 1440, and 1800
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Primary outcome [7]
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Baseline Immunoglobulin G (IgG) Over Time in OL Period
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Assessment method [7]
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Time-matched baseline (Day 0) values and post-baseline vales were presented for each post-baseline visit and represent only that cohort of participants with measurements available at that post-baseline assessment. Mean Change from Baseline data for these cohorts are presented in Outcome Measure 8.
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Timepoint [7]
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Baseline (Day 0) and Days 360, 720, 1080, 1440 and 1800
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Primary outcome [8]
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Mean Change From Baseline (BL) in IgG Over Time in OL Period
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Assessment method [8]
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Blood samples for immunoglobulin assessments were obtained to determine change from baseline in serum IgG. Baseline data for these cohorts are presented in Outcome Measure 7.
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Timepoint [8]
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Baseline (Day 0) and Days 360, 720, 1080, 1440, and 1800
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Primary outcome [9]
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Baseline Immunoglobulin M (IgM) Over Time in OL Period
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Assessment method [9]
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Time-matched baseline (Day 0) values and post-baseline values were presented for each post-baseline visit and represent only that cohort of participants with measurements available at that post-baseline assessment. Mean Change from Baseline data for these cohorts are presented in Outcome Measure 10.
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Timepoint [9]
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Baseline (Day 0) and Days 360, 720,1080,1440, and 1800
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Primary outcome [10]
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Mean Change From Baseline (BL) in IgM in OL Period
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Assessment method [10]
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Blood samples for immunoglobulin assessments were obtained to determine change from baseline in serum IgM. Baseline data for these time-matched cohorts are presented in Outcome Measure 9.
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Timepoint [10]
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Baseline (Day 0) and Days 360, 720, 1080, 1440, and 1800
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Primary outcome [11]
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Number of Participants With Hematology Values Meeting Marked Abnormality Criteria in OL Period
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Assessment method [11]
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Timepoint [11]
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Day 360 to Day 3060
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Primary outcome [12]
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Number of Participants With Liver and Kidney Function Values Meeting Marked Abnormality Criteria in OL Period
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Assessment method [12]
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Timepoint [12]
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Day 360 to Day 3060
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Primary outcome [13]
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Number of Participants With Electrolyte Values Meeting Marked Abnormality Criteria in OL Period
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Assessment method [13]
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Timepoint [13]
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Day 360 to Day 3060
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Primary outcome [14]
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Number of Participants With Glucose, Protein, Metabolites, and Urinalysis Values Meeting Marked Abnormality Criteria in OL Period
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Assessment method [14]
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Timepoint [14]
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Day 360 to Day 3060
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Secondary outcome [1]
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Number of ACR 20 Responders in DB Period
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Assessment method [1]
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ACR 20 response requires a participant to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits.
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Timepoint [1]
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Days 15, 30, 60, 90, 120, 150,180, 240, 300, and 360
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Secondary outcome [2]
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Number of ACR 50 Responders in DB Period
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Assessment method [2]
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ACR 50 response requires a participant to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 50 response if the participant had ACR 50 observed for at least 2 consecutive study visits.
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Timepoint [2]
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Day 15; Day 30; Day 60; Day 90; Day 120; Day 150; Day 180; Day 240; Day 300; Day 360
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Secondary outcome [3]
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Number of ACR 70 Responders in DB Period
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Assessment method [3]
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ACR 70 response requires a participant to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in three of the following five parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 70 response if the participant had ACR 70 observed for at least 2 consecutive study visits.
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Timepoint [3]
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Day 15; Day 30; Day 60; Day 90; Day 120; Day 150; Day 180; Day 240; Day 300; Day 360
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Secondary outcome [4]
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ACR Numeric Values (ACR-N)
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Assessment method [4]
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The ACR-N is calculated for each participant by taking the lowest percentage improvement in (1) swollen joint count or (2) tender joint count or (3) the median of the remaining 5 components of the ACR response (participant's assessment of disease activity; participant's global assessment of pain; physician's assessment of disease activity; participant's assessment of physical function; an acute phase reactant value - CRP). Negative numbers indicate worsening.
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Timepoint [4]
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Day 15; Day 30; Day 60; Day 90; Day 120; Day 150; Day 180; Day 240; Day 300; Day 360
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Secondary outcome [5]
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ACR-N Area Under The Curve (AUC) on Day 180 and Day 360
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Assessment method [5]
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The AUC for ACR-N is the measure of the area under the curve of the mean change from baseline in ACR-N. The trapezoidal rule was used to compute the AUC. The ACR-N AUC was compared between the two abatacept treatment groups and the placebo group using an analysis of variance (ANOVA) for 6- and 12-month data (Day 180 and Day 360). This allowed for the assessment of subject response throughout the study. See Measure Description in Outcome Measure 18 for a definition of ACR-N.
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Timepoint [5]
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Baseline and Day 180; Baseline and Day 360
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Secondary outcome [6]
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Individual Components of ACR Criteria--Mean Percentage Change From Baseline at Day 180
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Assessment method [6]
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Percentage change = 100\*(Baseline value - value at specific visit) / Baseline value. The American College of Rheumatology (ACR) response criteria, based on a core set of variables which includes a tender joint count, a swollen joint count, patient-reported pain scale (Subject Assessment of Physical Function \[SAPF\]), patient and physician global assessments of disease activity (Subject Global Assessment \[SGA\] and Physician Global Assessment \[PGA\]), patient assessment of functional ability, and an acute phase reactant (C-Reactive Protein \[CRP\])
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Timepoint [6]
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Baseline, Day 180
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Secondary outcome [7]
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Individual Components of ACR Criteria--Mean Percentage Change From Baseline at Day 360
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Assessment method [7]
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Percentage change = 100\*(Baseline value - value at specific visit) / Baseline value. The American College of Rheumatology (ACR) response criteria, based on a core set of variables which includes a tender joint count, a swollen joint count, patient-reported pain scale (Subject Assessment of Physical Function \[SAPF\]), patient and physician global assessments of disease activity (Subject Global Assessment \[SGA\] and Physician Global Assessment \[PGA\]), patient assessment of functional ability, and an acute phase reactant (C-Reactive Protein \[CRP\])
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Timepoint [7]
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Baseline, Day 360
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Secondary outcome [8]
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Mean Changes From Baseline in the Short Form 36 (SF-36) Physical and Mental Health Component Summary Scores (PCS and MCS) at Day 180 and Day 360
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Assessment method [8]
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SF-36 measures health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores: PCS=physical functioning, role-physical, bodily pain, and general health; MCS=vitality, social functioning, role-emotional, and mental health. Scoring is done for both subscores and summary scores. For both, 0=worst score (or quality of life) and 100=best score.
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Timepoint [8]
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Baseline, Day 180, Day 360
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Secondary outcome [9]
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Adjusted Mean Percent Changes From Baseline in the Modified Health Assessment Questionnaire (mHAQ) at Day 180 and Day 360
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Assessment method [9]
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A shortened version of the Health Assessment Questionnaire (HAQ), which uses only 8 instead of the 20 original items and is used to assess motor performance in everyday activities, such as dressing, turning a faucet on/off, and getting in and out of a car. Percent change from baseline = (baseline - post baseline value) / baseline value x 100.
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Timepoint [9]
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Baseline, Day 180, Day 360
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Secondary outcome [10]
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Number of Participants With At Least One New Active Joint (Tender Joints and Swollen Joints) at Day 180 and Day 360
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Assessment method [10]
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Timepoint [10]
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Day 180, Day 360
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Secondary outcome [11]
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Participants Who Experienced Death, Adverse Events (AEs), Serious AEs (SAEs), and Discontinuations During the Double-Blind Period
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Assessment method [11]
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AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was an overdose. Participants who discontinued the study due to any AEs were recorded. Related events include those that were considered by the investigator to be certain, probable, or possibly related to study drug.
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Timepoint [11]
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From the start of study through the end of the double-blind period (at 12 months)
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Secondary outcome [12]
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Participants With Laboratory Abnormalities Meeting the Marked Abnormality Criteria for Selected Blood Chemistry Values During Double-Blind Therapy
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Assessment method [12]
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Timepoint [12]
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From the start of study up to 60 days post the end of the 12-month double-blind period
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Secondary outcome [13]
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Participants With Laboratory Abnormalities Meeting the Marked Abnormality Criteria for Selected Hematologic Values During Double-Blind Therapy
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Assessment method [13]
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Timepoint [13]
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From the start of study up to 60 days post the end of the 12-month double-blind period
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Secondary outcome [14]
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Number of Participants Who Discontinued Due to Lack of Efficacy in the DB and OL Periods
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Assessment method [14]
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Timepoint [14]
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Day 1 to Day 360 (Double-Blind Period), Day 361 to Day 3060 (Open-Label Period)
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Secondary outcome [15]
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Immunogenicity Data: Anti-CTLA4Ig Antibodies With Immunoglobulin (IG) Region
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Assessment method [15]
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0
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Timepoint [15]
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Baseline, Days 30, 90, 180, 270, 360
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Secondary outcome [16]
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Immunogenicity Data: Anti-CTLA4Ig Antibodies Without IG Region
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Assessment method [16]
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Timepoint [16]
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Baseline, Days 30, 90, 180, 270, 360
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Secondary outcome [17]
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Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion (Anti-CTLA4Ig Antibodies With IG Region)
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Assessment method [17]
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Number of participants with ratio of VA/PRE \<=3, \<3 to \<=9, and \>9. Ratios greater than 9 are incidences of Anti-CTLA4Ig sero-conversion.
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Timepoint [17]
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Baseline, Days 30, 90, 180, 270, 360
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Secondary outcome [18]
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Immunogenicity Data: Categories of Post Baseline Value to Baseline Value (VA/PRE) Ratios and Number of Participants With Sero-conversion(Anti-CTLA4Ig Antibodies Without IG Region)
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Assessment method [18]
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Number of participants with ratio of VA/PRE \<=3, \<3 to \<=9, and \>9. Ratios greater than 9 are incidences of Anti-CTLA4Ig sero-conversion.
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Timepoint [18]
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Baseline, Days 30, 90, 180, 270, 360
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Secondary outcome [19]
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Pharmacodynamic Measure: Mean Changes From Baseline in Rheumatoid Factor at Day 180 and Day 360
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Assessment method [19]
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Timepoint [19]
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Baseline, Day 180, Day 360
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Secondary outcome [20]
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Pharmacodynamic Measure: Mean Changes From Baseline in Interleukin-6 at Day 180 and Day 360
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Assessment method [20]
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0
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Timepoint [20]
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Baseline, Day 180, Day 360
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Secondary outcome [21]
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Pharmacodynamic Measure: Mean Changes From Baseline in Plasma Soluble Interleukin-2 Receptor (sIL-2R) at Day 180 and Day 360
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Assessment method [21]
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0
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Timepoint [21]
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Baseline, Day 180, Day 360
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Secondary outcome [22]
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Pharmacodynamic Measure: Mean Changes From Baseline in E-Selectin at Day 180 and Day 360
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Assessment method [22]
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0
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Timepoint [22]
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Baseline, Day 180, Day 360
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Secondary outcome [23]
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Pharmacodynamic Measure: Mean Changes From Baseline in Soluble Inter-Cellular Adhesion Molecule 1 (sICAM-1) at Day 180 and Day 360
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Assessment method [23]
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0
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Timepoint [23]
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Baseline, Day 180, Day 360
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Secondary outcome [24]
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Pharmacodynamic Measure: Mean Changes From Baseline in Tumor Necrosis Factor (TNF)-Alpha at Day 180 and Day 360
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Assessment method [24]
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0
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Timepoint [24]
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Baseline, Day 180, Day 360
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Secondary outcome [25]
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Number of ACR 20 Responders in OL Period
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Assessment method [25]
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ACR 20 response requires a participant to have a 20% reduction in the number of swollen and tender joints, and a reduction of 20% in three of the following five parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in Health Assessment Questionnaire score. A participant achieved a sustained ACR 20 response if the participant had ACR 20 observed for at least 2 consecutive study visits.
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Timepoint [25]
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Days 360, 450, 540, 630, 720, 810, 900, 1080, 1350, 1440, 1530, 1620, 1710, 1800, 1980, 2160, 2340, 2520, 2700, 2880, and 3060
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Secondary outcome [26]
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Number of ACR 50 Responders in the OL Period
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Assessment method [26]
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ACR 50 response requires a participant to have a 50% reduction in the number of swollen and tender joints, and a reduction of 50% in three of the following five parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 50 response if the participant had ACR 50 observed for at least 2 consecutive study visits.
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Timepoint [26]
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0
Days 360, 450, 540, 630, 720, 810, 900, 1080, 1350, 1440, 1530, 1620, 1710, 1800, 1980, 2160, 2340, 2520, 2700, 2880, and 3060
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Secondary outcome [27]
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Number of ACR 70 Responders in the OL Period
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Assessment method [27]
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0
ACR 70 response requires a participant to have a 70% reduction in the number of swollen and tender joints, and a reduction of 70% in 3 of the following 5 parameters: physician global assessment of disease, participant global assessment of disease, participant assessment of pain, C-reactive protein or erythrocyte sedimentation rate, and degree of disability in HAQ score. A participant achieved a sustained ACR 70 response if the participant had ACR 70 observed for at least 2 consecutive study visits.
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Timepoint [27]
0
0
Days 360, 450, 540, 630, 720, 810, 900, 1080, 1350, 1440, 1530, 1620, 1710, 1800, 1980, 2160, 2340, 2520, 2700, 2880, and 3060
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Secondary outcome [28]
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Number of Participants With a Clinically Meaningful Improvement on the Modified Health Assessment Questionnaire (mHAQ) in OL Period
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Assessment method [28]
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The mHAQ is a self-administered questionnaire composed of 20 questions that assess physical functions in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, and common activities. The answers are graded on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, and 3=unable to do. The HAQ disease index is a weighted sum of the scale scores, with a higher score indicating poorer function. A clinically meaningful improvement was defined as a reduction from baseline in mHAQ score of at least 0.30 units.
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Timepoint [28]
0
0
Days 360, 720,1080, 1440, 1800, 2160, 2520, 2880, and 3060
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Secondary outcome [29]
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Baseline Level of Serum Rheumatoid Factor Over Time in OL Period
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Assessment method [29]
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Serum evaluations were carried out to determine participant baseline rheumatoid factor serum concentration. Time-matched baseline(Day 0) values and post-baseline vales were presented for each post-baseline visit and represent only that cohort of participants with measurements available at that post-baseline assessment.
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Timepoint [29]
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0
Baseline (Day 0) and Days 360, 720,1080, 1440, 1800, 2160, 2520, 2880, and 3060
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Secondary outcome [30]
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0
Mean Change From Baseline in Serum Rheumatoid Factor Level Over Time in OL Period
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Assessment method [30]
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Serum evaluations were carried out to determine participant change from baseline in rheumatoid factor serum concentration. Mean change from baseline = value at post-baseline OL time point-value and baseline OL time point.
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Timepoint [30]
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0
Baseline (Day 0) and Days 360, 720,1080, 1440, 1800, 2160, 2520, 2880, and 3060
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Secondary outcome [31]
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0
Mean Baseline Soluble Serum Interleukin-2 Receptor Level (sIL2-r) Over Time in OL Period
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Assessment method [31]
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Serum evaluations were carried out to determine participant serum levels of sIL2-r at baseline. Time-matched baseline (Day 0) values and post-baseline vales were presented for each post-baseline visit and represent only that cohort of participants with measurements available at that post-baseline assessment.
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Timepoint [31]
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0
Baseline (Day 0) and Days 360, 720,1080, 1440, 1800, 2160, 2520, 2880, and 3060
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Secondary outcome [32]
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0
Mean Change From Baseline in sIL2-r Over Time in OL Period
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Assessment method [32]
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0
Serum evaluations were carried out to determine participant serum levels of sIL2-r. Mean change from baseline=value at post-baseline OL time point-value and baseline OL time point.
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Timepoint [32]
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0
Baseline (Day 0) and Days 360, 720, 1080, 1440, and 1800
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Secondary outcome [33]
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0
Mean Baseline Serum C-Reactive Protein Level Over Time in OL Period
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Assessment method [33]
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Serum evaluations were carried out to evaluate participant serum CRP concentrations at baseline. Time-matched BL (Day 0) values and post-BL vales were presented for each post-BL visit and represent only that cohort of participants with measurements available at that post-BL assessment.
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Timepoint [33]
0
0
Baseline (Day 0) and Days 360, 720, 1080,1440,1800, 2160, 2520, 2880, 3060
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Secondary outcome [34]
0
0
Mean Change From Baseline in Level of C Reactive Protein Over Time in OL Period
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Assessment method [34]
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Serum evaluations were carried out to evaluate participant concentrations of serum C reactive protein. Mean change from baseline=value at post-baseline OL time point-value and baseline OL time point.
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Timepoint [34]
0
0
Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, 3060
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Secondary outcome [35]
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0
Mean Baseline Physical Component Summary (PCS) of the Short-Form 36 (SF-36) Over Time in OL Period
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Assessment method [35]
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SF-36 = PCS \& MCS \& 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, \& mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 \& a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL \& post-BL values are presented for each post-BL visit \& represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 50.
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Timepoint [35]
0
0
Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2880, and 3060
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Secondary outcome [36]
0
0
Mean Change From Baseline (BL) in the Physical Component Summary (PCS) of the SF-36 Over Time in OL Period
Query!
Assessment method [36]
0
0
The SF-36 consists of 2 summaries, the PCS and the MCS, and 8 individual indexes. The MCS addresses 4 of the 8 individual indices: vitality, social functioning, role-emotional, and mental health. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from baseline=value at post-baseline OL time point-value and baseline OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 49.
Query!
Timepoint [36]
0
0
Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2880, and 3060
Query!
Secondary outcome [37]
0
0
Mean Baseline Mental Component Summary (MCS) of the SF-36 Over Time in OL Period
Query!
Assessment method [37]
0
0
SF-36=PCS, MCS, \& 8 individual indices. MCS addresses 4 of the 8 indices: vitality, social functioning, role-emotional, \& mental health. Subscales were scored using norm-based methods that standardized the scores to a mean of 50 \& a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched baseline (Day 0) values \& post-baseline (BL) values are presented for each post-BL visit \& represent only that cohort with measurements available at that post-BL assessment. See Outcome Measure 51 for Change from BL.
Query!
Timepoint [37]
0
0
Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2880, and 3060
Query!
Secondary outcome [38]
0
0
Mean Change From Baseline (BL) in the MCS of the SF-36 Over Time in OL Period
Query!
Assessment method [38]
0
0
The SF-36 consists of 2 summaries, the PCS and the MCS, and 8 individual indexes. The MCS addresses 4 of the 8 individual indices: vitality, social functioning, role-emotional, and mental health. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from baseline=value at post-baseline OL time point-value and baseline OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 51.
Query!
Timepoint [38]
0
0
Baseline (Day 0) and Days 360, 450, 540, 630, 720, 810, 900, 1080, 1350, 1440, 1530, 1620, 1710, 1800, 1980, 2160, 2340, 2520, 2700, 2880, and 3060
Query!
Secondary outcome [39]
0
0
Mean Baseline (BL) Physical Functioning Domain of the SF-36 Over Time in OL Period
Query!
Assessment method [39]
0
0
SF-36 = PCS \& MCS \& 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, \& mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 \& a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL \& post-BL values are presented for each post-BL visit \& represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 54.
Query!
Timepoint [39]
0
0
Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060
Query!
Secondary outcome [40]
0
0
Mean Change From Baseline (BL) in the Physical Functioning Domain of the SF-36 Over Time in OL Period
Query!
Assessment method [40]
0
0
SF-36=2 summaries (PCS \& MCS) \& 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, \& mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 \& a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 53.
Query!
Timepoint [40]
0
0
Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060
Query!
Secondary outcome [41]
0
0
Mean Baseline Role-Physical Domain of the SF-36 Over Time in OL Period
Query!
Assessment method [41]
0
0
SF-36 = PCS \& MCS \& 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, \& mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 \& a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL \& post-BL values are presented for each post-BL visit \& represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 56.
Query!
Timepoint [41]
0
0
Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060
Query!
Secondary outcome [42]
0
0
Mean Change From Baseline (BL) in the Role-Physical Domain of the SF-36 Over Time in OL Period
Query!
Assessment method [42]
0
0
SF-36=2 summaries (PCS \& MCS) \& 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, \& mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 \& a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 55.
Query!
Timepoint [42]
0
0
Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060
Query!
Secondary outcome [43]
0
0
Mean Baseline Bodily Pain Domain of the SF-36 Over Time in OL Period
Query!
Assessment method [43]
0
0
SF-36 = PCS \& MCS \& 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, \& mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 \& a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL \& post-BL values are presented for each post-BL visit \& represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 58.
Query!
Timepoint [43]
0
0
Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060
Query!
Secondary outcome [44]
0
0
Mean Change From BL in the Bodily Pain Domain of the SF-36 Over Time in OL Period
Query!
Assessment method [44]
0
0
SF-36=2 summaries (PCS \& MCS) \& 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, \& mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 \& a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 57.
Query!
Timepoint [44]
0
0
BL (Day 0); Day 360; Day 720; Day 1,080; Day 1,440; Day 1,800; Day 2,160; Day 2,520; Day 2,880; Day 3,060
Query!
Secondary outcome [45]
0
0
Mean BL General Health Domain of the SF-36 Over Time in OL Period
Query!
Assessment method [45]
0
0
SF-36 = PCS \& MCS \& 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, \& mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 \& a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL \& post-BL values are presented for each post-BL visit \& represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 60.
Query!
Timepoint [45]
0
0
Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060
Query!
Secondary outcome [46]
0
0
Mean Change From Baseline (BL) in the General Health Domain of the SF-36 Over Time in OL Period
Query!
Assessment method [46]
0
0
SF-36=2 summaries (PCS \& MCS) \& 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, \& mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 \& a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 59.
Query!
Timepoint [46]
0
0
Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060
Query!
Secondary outcome [47]
0
0
Mean Baseline Vitality Domain of the SF-36 Over Time in OL Period
Query!
Assessment method [47]
0
0
SF-36 = PCS \& MCS \& 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, \& mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 \& a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL \& post-BL values are presented for each post-BL visit \& represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 62.
Query!
Timepoint [47]
0
0
Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060
Query!
Secondary outcome [48]
0
0
Mean Change From Baseline (BL) in the Vitality Domain of the SF-36 Over Time in OL Period
Query!
Assessment method [48]
0
0
SF-36=2 summaries (PCS \& MCS) \& 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, \& mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 \& a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 61.
Query!
Timepoint [48]
0
0
Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060
Query!
Secondary outcome [49]
0
0
Mean Baseline Social Functioning Domain of the SF-36 Over Time in OL Period
Query!
Assessment method [49]
0
0
SF-36 = PCS \& MCS \& 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, \& mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 \& a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL \& post-BL values are presented for each post-BL visit \& represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 64.
Query!
Timepoint [49]
0
0
Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060
Query!
Secondary outcome [50]
0
0
Mean Change From Baseline (BL) in the Social Functioning Domain of the SF-36 Over Time in OL Period
Query!
Assessment method [50]
0
0
SF-36=2 summaries (PCS \& MCS) \& 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, \& mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 \& a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 63.
Query!
Timepoint [50]
0
0
Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060
Query!
Secondary outcome [51]
0
0
Mean Baseline Role-Emotional Domain of the SF-36 Over Time in OL Period
Query!
Assessment method [51]
0
0
SF-36 = PCS \& MCS \& 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, \& mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 \& a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL \& post-BL values are presented for each post-BL visit \& represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 66.
Query!
Timepoint [51]
0
0
Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060
Query!
Secondary outcome [52]
0
0
Mean Change From Baseline (BL) in the Role-Emotional Domain of the SF-36 Over Time in OL Period
Query!
Assessment method [52]
0
0
SF-36=2 summaries (PCS \& MCS) \& 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, \& mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 \& a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 65.
Query!
Timepoint [52]
0
0
Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060
Query!
Secondary outcome [53]
0
0
Mean Baseline Mental Health Domain of the SF-36 Over Time in OL Period
Query!
Assessment method [53]
0
0
SF-36 = PCS \& MCS \& 8 individual indices (physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, \& mental health). Subscales were scored using norm-based methods that standardized scores to a mean of 50 \& a standard deviation of 10 in the general population. Scores range from 0 to 100, with a higher score indicating better quality of life. Time-matched BL \& post-BL values are presented for each post-BL visit \& represent only that cohort with measurements available at that assessment. Change from BL data are presented in Outcome Measure 68.
Query!
Timepoint [53]
0
0
Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060
Query!
Secondary outcome [54]
0
0
Mean Change From Baseline (BL) in the Mental Health Domain of the SF-36 Over Time in OL Period
Query!
Assessment method [54]
0
0
SF-36=2 summaries (PCS \& MCS) \& 8 individual indices including physical function, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, \& mental health. All subscales were scored using norm-based methods that standardized the scores to a mean of 50 \& a standard deviation of 10 in the general population. The scores range from 0 to 100, with a higher score indicating better quality of life. Mean change from BL = value at post-BL OL time point-value and BL OL time point. Baseline data for these time-matched cohorts are presented in Outcome Measure 67.
Query!
Timepoint [54]
0
0
Baseline (Day 0) and Days 360, 720, 1080, 1440, 1800, 2160, 2520, 2880, and 3060
Query!
Eligibility
Key inclusion criteria
Double blind study phase:
1. Males or females (not nursing and not pregnant), at least 18 years of age. Women of child bearing potential (WOCBP) are eligible if they are practicing effective contraceptive measures
2. Subjects must meet the criteria of the American Rheumatism Association (1987) for the diagnosis of rheumatoid arthritis and the American College of Rheumatology (1991) functional classes I, II, or III
3. Subjects have been taking Methotrexate (10-30 mg weekly) for at least 6 months, and at a stable dose for 28 days prior to treatment
4. Washout/drug stabilization requirements (except Methotrexate) [Informed consent must be signed before making any changes in RA therapy if those changes are solely for the purpose of this study].
* Leflunomide or Infliximab have already been discontinued at least 60 days prior to enrollment (prior to signing of informed consent) and a total of 90 days prior to treatment. All other Disease Modifying Anti-Rheumatic Drugs (DMARDs) (except Methotrexate) have been withdrawn at least 28 days prior to treatment
* Oral corticosteroid treatment has been reduced to the equivalent of 10 mg or less prednisone daily and stabilized for at least 28 days prior to enrollment
5. Eligibility of subjects for the study is based on their disease activity and anti-rheumatic treatment at the initial visit:
* Methotrexate monotherapy: Subject is receiving only Methotrexate, steroids, Non-steroidal anti-inflammatory drugs (NSAIDs) and will not require washout
* Combination therapy: Subject is receiving Methotrexate in combination with another DMARD(s) and will require washout
At entry, Methotrexate monotherapy must have a disease activity:
* 10 or more swollen joints (66 joint count)
* 12 or more tender joints (68 joint count)
* C reactive protein (CRP) =.1 mg/dL (10 mg/L) at "Screening" visit
At entry, combination therapy must have a disease activity (if subject does not satisfy the above):
* 6 or more swollen joints (66 joint count)
* 8 or more tender joints (68 joint count)
* No restriction on C-reactive protein (CRP)
In addition
All subjects who were on combination therapy at entry must undergo a 28 day washout period of DMARDs other than Methotrexate. After the washout/drug stabilization and prior to randomization such subjects must have:
* 10 or more swollen joints (66 joint count)
* 12 or more tender joints (68 joint count)
* C reactive protein (CRP) = 1 mg/dL (10 mg/L)
6. Subject is willing to participate in the study and willing to sign the informed consent
Open label study phase:
* Participants that have completed the initial short term portion (double blind) of the study
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Double blind study phase:
1. Subjects who have at any time received treatment with BMS-188667 (Abatacept)
2. Subjects who within 30 days of the Day 1 visit have received treatment with any investigational drug
3. Subjects with active vasculitis of a major organ system (except for subcutaneous rheumatoid nodules)
4. Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological, or cerebral disease. Concomitant medical conditions that in the opinion of the investigator might place the subject at unacceptable risk for participation in this study
5. Mammogram requiring further investigation or biopsies leading to the diagnosis of a clinically significant abnormality. Complete evaluation of lesion is required before initiation of dosing
6. Subjects with a history of cancer within the last five years (other than non-melanoma skin cell cancers cured by local resection)
7. Subjects who have a history of clinically significant drug or alcohol abuse, or admit to consumption of more than 1 alcoholic drink per day
8. Subjects with evidence (as assessed by the investigator) of active or latent bacterial or viral infections at the time of potential enrollment, including subjects with evidence of Human Immunodeficiency Virus (HIV) infection, or hepatitis B or C infection
9. Subjects with any serious or chronic infections such as pneumonia, pyelo-nephritis, renal infection, chest infection with bronchiectasis, or sinusitis in the previous 3 months
10. Subjects with active tuberculosis requiring treatment within the previous 3 years
11. Subjects with any opportunistic infections such as herpes zoster or cytomegalovirus (CMV) within the previous 2 months
12. Subjects with severe asthma defined as > 3 emergency room admissions in the last year or > 3 treatments with oral steroids for asthma in the last year
13. A history of either angioedema or anaphylaxis that was associated with a reaction to a drug
14. Subjects with the following laboratory values:
* Hemoglobin < 8.5 g/dL
* White blood cells < 3000/mm3
* Platelets < 100,000/mm3
* Serum creatinine > 2 times upper limit of normal
* Serum Alanine aminotransferase (ALAT) or Aspartate aminotransferase (ASAT) > 2 times upper limit of normal
* Any other lab values that in the opinion of the investigator might place the subject at unacceptable risk for participation in this study
Open label study phase:
* Participants must continue to meet inclusion/exclusion criteria as in the short term (double blind) phase of the protocol except subjects who have receiving other than Abatacept
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/10/2000
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/09/2009
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
524
Query!
Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
Query!
Recruitment hospital [1]
0
0
Local Institution - Adelaide
Query!
Recruitment hospital [2]
0
0
Local Institution - Malvern
Query!
Recruitment hospital [3]
0
0
Local Institution - Perth
Query!
Recruitment postcode(s) [1]
0
0
- Adelaide
Query!
Recruitment postcode(s) [2]
0
0
- Malvern
Query!
Recruitment postcode(s) [3]
0
0
- Perth
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Colorado
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Florida
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Georgia
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Illinois
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Kansas
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Maryland
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Massachusetts
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Minnesota
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Nebraska
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
New Mexico
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
New York
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Oregon
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Pennsylvania
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Texas
Query!
Country [17]
0
0
Argentina
Query!
State/province [17]
0
0
Burenos Aires
Query!
Country [18]
0
0
Argentina
Query!
State/province [18]
0
0
Buenos Aries
Query!
Country [19]
0
0
Belgium
Query!
State/province [19]
0
0
Antwerpen
Query!
Country [20]
0
0
Belgium
Query!
State/province [20]
0
0
Bruxelles
Query!
Country [21]
0
0
Belgium
Query!
State/province [21]
0
0
Gent
Query!
Country [22]
0
0
Belgium
Query!
State/province [22]
0
0
Leuven
Query!
Country [23]
0
0
Belgium
Query!
State/province [23]
0
0
Mons
Query!
Country [24]
0
0
Canada
Query!
State/province [24]
0
0
Alberta
Query!
Country [25]
0
0
Canada
Query!
State/province [25]
0
0
Ontario
Query!
Country [26]
0
0
Canada
Query!
State/province [26]
0
0
Quebec
Query!
Country [27]
0
0
Canada
Query!
State/province [27]
0
0
St. John
Query!
Country [28]
0
0
France
Query!
State/province [28]
0
0
Cedex
Query!
Country [29]
0
0
France
Query!
State/province [29]
0
0
Paris
Query!
Country [30]
0
0
Germany
Query!
State/province [30]
0
0
Berlin
Query!
Country [31]
0
0
Germany
Query!
State/province [31]
0
0
Freiburg
Query!
Country [32]
0
0
Germany
Query!
State/province [32]
0
0
Jena
Query!
Country [33]
0
0
Ireland
Query!
State/province [33]
0
0
Cork
Query!
Country [34]
0
0
Netherlands
Query!
State/province [34]
0
0
Nijmegen
Query!
Country [35]
0
0
South Africa
Query!
State/province [35]
0
0
Gauteng
Query!
Country [36]
0
0
South Africa
Query!
State/province [36]
0
0
Western Cape
Query!
Country [37]
0
0
United Kingdom
Query!
State/province [37]
0
0
Cambridgeshire
Query!
Country [38]
0
0
United Kingdom
Query!
State/province [38]
0
0
Greater Manchester
Query!
Country [39]
0
0
United Kingdom
Query!
State/province [39]
0
0
Kent
Query!
Country [40]
0
0
United Kingdom
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State/province [40]
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Yorkshire
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Bristol-Myers Squibb
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Address
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Ethics approval
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Summary
Brief summary
This study was conducted to assess the safety and tolerability of Abatacept combined with Methotrexate in participants with active rheumatoid arthritis (RA). The secondary objectives were to assess efficacy, pharmacodynamic marker activity, and immunogenicity of Abatacept combined with Methotrexate.
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Trial website
https://clinicaltrials.gov/study/NCT00162266
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Trial related presentations / publications
Westhovens R, Kremer JM, Emery P, Russell AS, Alten R, Barre E, Dougados M. Long-term safety and efficacy of abatacept in patients with rheumatoid arthritis and an inadequate response to methotrexate: a 7-year extended study. Clin Exp Rheumatol. 2014 Jul-Aug;32(4):553-62. Epub 2014 Jul 8.
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Public notes
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Contacts
Principal investigator
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Bristol-Myers Squibb
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Bristol-Myers Squibb
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Contact person for public queries
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00162266
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