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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01173120
Registration number
NCT01173120
Ethics application status
Date submitted
28/07/2010
Date registered
30/07/2010
Date last updated
12/01/2012
Titles & IDs
Public title
Methotrexate - Inadequate Response Device Sub-Study
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Scientific title
Sub-study-A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Abatacept Administered Subcutaneously and Intravenously in Subjects With Rheumatoid Arthritis, Receiving Background Methotrexate, and Experiencing an Inadequate Response to Methotrexate
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Secondary ID [1]
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2007-005434-37
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Secondary ID [2]
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IM101-174 (Sub study)
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Universal Trial Number (UTN)
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Trial acronym
MTX-IR
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis (RA)
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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: Devices - Abatacept combination product (ACP)
Experimental: Abatacept Combination Product (ACP) - Participants from the long-term period of study NCT00559585 who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a pre-filled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
Treatment: Devices: Abatacept combination product (ACP)
Abatacept Solution, Subcutaneous, 125 mg/device, Weekly, 3 months
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Intervention code [1]
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Treatment: Devices
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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 Participants With Death, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Treatment-related AEs, and AEs Leading to Discontinuation
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Assessment method [1]
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An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=possibly, probably, or certainly related to and of unknown relationship to study treatment.
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Timepoint [1]
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ACP substudy Day 1 to last substudy assessment occurring prior to the 1st dose of non-ACP subcutaneous (SC) abatacept, assessed up to 12 months
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Primary outcome [2]
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Number of Participants With AEs of Special Interest in the ACP Device Substudy
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Assessment method [2]
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AE=any new untoward medical occurrence or worsening of a preexisting medical condition which does not necessarily have a causal relationship with this treatment. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs including all infections, local injection reactions (prespecified), and systemic injection reactions (within 24 hours of dosing).
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Timepoint [2]
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ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 56 days post last ACP dose
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Primary outcome [3]
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Number of Participants With Laboratory Test Results in Hematology Meeting the Criteria for Marked Abnormality in the ACP Device Substudy
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Assessment method [3]
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BL=baseline; LLN lower limit of normal; ULN=upper limit of normal. Marked abnormality criteria: Hemoglobin: \>3 g/dL decrease from BL; Hematocrit: \<0.75\*BL; Erythrocytes: \<0.75\*BL; Platelets: \<0.67\*LLN/\>1.5\*ULN, or if BL \<LLN, use 0.5\*BL/\<100,000 mm\^3; Leukocytes: \<0.75\*LLN/ \>1.25\*ULN, or if BL\<LLN, use \<0.8\*BL/\>ULN, or if BL\>ULN, use \>1.2\*BL/\<LLN; neutrophils+bands: \<1.0\*10\^3 c/uL; eosinophils: \>0.750\*10\^3 c/uL; basophils: \>400 mm\^3; monocytes: \>2000 mm\^3; lymphocytes: \<0.750\*10\^3 c/uL/ \>7.50\*10\^3 c/uL.
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Timepoint [3]
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ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose.
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Primary outcome [4]
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Number of Participants With Liver Function Laboratories Meeting MA Criteria in the ACP Device Substudy
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Assessment method [4]
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Marked abnormality criteria: Alkaline phosphatase (ALP): \>2\* ULN, or if BL\>ULN then use \>3\* BL; aspartate aminotransferase (AST): \>3\* ULN, or if BL\>ULN then use \>4\* BL; alanine aminotransferase (ALT): \>3\* ULN, or if BL\>ULN then use \>4\* BL; G-Glutamyl transferase (GGT): \>2\* ULN, or if BL\>ULN then use \>3\* BL; Bilirubin: \>2\* ULN, or if BL\>ULN then use \>4\* BL; blood urea nitrogen (BUN): \>2\* BL; creatinine: \>1.5\* BL
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Timepoint [4]
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ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose.
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Primary outcome [5]
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Number of Participants With Electrolyte Laboratories Meeting MA Criteria in the ACP Device Substudy
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Assessment method [5]
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Marked abnormality criteria: Sodium (Na): \<0.95\*LLN/ \>1.05\*ULN, or if BL\<LLN then use \<0.95\* BL or \>ULN, or if BL\>ULN then use\>1.05\* BL or \<LLN; potassium (K): \<0.9\* LLN/\>1.1\*ULN, or if BL\<LLN then use \<0.9\* BL or \>ULN, or if BL\>ULN then use\>1.1\* BL or \<LLN; (Cl): \<0.9\* LLN/\>1.1\* ULN, or if BL\<LLN then use \<0.9\* BL or \>ULN, or if BL\>ULN then use\>1.1\* BL or \<LLN; calcium (Ca): \<0.8\* LLN/\>1.2\* ULN, or if BL\<LLN then use \<0.75\* BL or \>ULN, or if BL\>ULN then use\>1.25\* BL or \<LLN; phosphorous (P): \<0.75\* LLN/ \>1.25\* ULN, or if BL\<LLN then use 0.67\* BL or \>ULN, or if BL\>ULN then use\>1.33\* BL or \<LLN
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Timepoint [5]
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ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose.
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Primary outcome [6]
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Number of Participants With Other Chemistry and Urinalysis Laboratories Meeting MA Criteria in the ACP Device Substudy
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Assessment method [6]
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MA criteria: serum glucose (Glu): \<65 mg/dL/\>220 mg/dL;fasting serum Glu: \<0.8\* LLN/\>1.5\*ULN,or if BL\<LLN then use 0.8\*BL or \>ULN,or if BL\>ULN then use \>2.0\*BL or \<LLN;total protein: \<0.9\*LLN/\>1.1\*ULN,or if BL\<LLN then use \<0.9\*BL or \>UNL,or if BL\>UNL then use \>1.1\*BL or \<LLN; albumin: \<0.9\*LLN,or if BL\<LLN then use \<0.75 BL;uric acid: \>1.5\*ULN,or if BL\>ULN then use \>2\*BL. Urinalysis (Urine protein,urine Glu,urine blood,leukocyte esterase,Red Blood Cells \[RBCs\], White Blood Cells \[WBCs\]):Use =2 when BL value missing or when pre-dose=0 or 0.5; use =3 when pre-dose=1, use =4 when pre-dose=2 or 3
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Timepoint [6]
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ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose.
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Primary outcome [7]
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Mean Systolic Blood Pressure (SBP) Over Time in the ACP Device Substudy
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Assessment method [7]
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Timepoint [7]
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ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose.
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Primary outcome [8]
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Mean Diastolic Blood Pressure (DBP) Over Time in the ACP Device Substudy
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Assessment method [8]
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Timepoint [8]
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ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose.
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Primary outcome [9]
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Mean Heart Rate Over Time in the ACP Device Substudy
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Assessment method [9]
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Timepoint [9]
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ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose.
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Primary outcome [10]
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Mean Temperature Over Time in the ACP Device Substudy
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Assessment method [10]
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Timepoint [10]
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ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 7 days post last ACP dose.
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Secondary outcome [1]
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Minimum Observed Serum Concentration (Cmin) of Abatacept Over Time in the ACP Device Substudy
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Assessment method [1]
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Trough levels of abatacept were evaluated based upon serum samples. Day 1 pharmacokinetics were based on exposure to the pre-filled syringes and did not reflect abatacept exposure via the ACP device.
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Timepoint [1]
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Days 1, 29, 57, 85, 169, and 253 of ACP substudy
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Secondary outcome [2]
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Number of Participants With Positive Anti-abatacept or Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4-T) Responses Over Time by Enzyme Linked Immunosorbant Assay (ELISA) in the ACP Device Substudy
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Assessment method [2]
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Serum samples from all treated adult participants with active rheumatoid arthritis were screened for the presence of drug-specific antibodies using ELISA. Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody.
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Timepoint [2]
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ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 28 days post last ACP dose
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Secondary outcome [3]
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Number of Participants With Positive Anti-abatacept Responses Over Time by Electrochemiluminescence Immunoassay in the ACP Device Substudy
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Assessment method [3]
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An electrochemiluminescence immunoassay screened sera for drug-specific antibodies; immunocompetition was used to identify specific anti-Abatacept reactivity. CTLA4 and Possibly immunoglobulin (Ig) category=reactivity against extracellular domain of human CTLA4, constant regions of human IgG1, or both (CTLA4Ig; Abatacept molecule). Ig and/or Junction (JNCT)category=reactivity against constant regions and/or hinge region of human IgG1. Drug-induced seropositivity defined as a post-baseline titer higher than Baseline, or any post-baseline positivity if Baseline value was missing. TRT=treatment
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Timepoint [3]
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ACP substudy Day 1 to last substudy assessment occurring prior to 1st dose of non-ACP SC abatacept (administered once participants switched back to main study). For participants discontinuing both studies: Day 1 of ACP dosing to 85 days post last ACP dose
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Eligibility
Key inclusion criteria
* Men and women, ages = 18
* Participants who are considered methotrexate inadequate responders (MTX-IR)
* 10 or more swollen joints (66 joint count) and 12 or more tender joints (68 joint count)
* Participants were to have been enrolled in the main MTX-IR study and been treated with open label abatacept for at least 3 months in the long term period
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Participants who failed one or multiple anti-tumor necrosis factor (TNF) therapies
* Participants who meet diagnostic criteria for any other rheumatic disease (e.g., lupus erythematosus)
* Participants with active vasculitis of a major organ system (except for subcutaneous rheumatoid nodules)
* Participants with severe chronic or recurrent bacterial infections
* Participants who have received treatment with rituximab
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/07/2010
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Sample size
Target
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Accrual to date
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Final
62
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Recruitment in Australia
Recruitment state(s)
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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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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to determine the safety and acceptability of a device used in place of traditional syringes for abatacept self-injection.
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Trial website
https://clinicaltrials.gov/study/NCT01173120
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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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/NCT01173120
Download to PDF