Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00175877
Registration number
NCT00175877
Ethics application status
Date submitted
9/09/2005
Date registered
15/09/2005
Date last updated
26/03/2020
Titles & IDs
Public title
A Study of the Safety and Effectiveness of Lyophilized Certolizumab Pegol in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis
Query!
Scientific title
A Phase III Multi-centre, Open-label, follow-on Study to CDP870-027, to Assess the Efficacy and Safety of Lyophilized CDP870 an Engineered Human Anti-TNF PEG Conjugate, as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and Preventing Structural Damage in Patients With Active Rheumatoid Arthritis
Query!
Secondary ID [1]
0
0
2005-001350-24
Query!
Secondary ID [2]
0
0
C87028
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis
0
0
Query!
Condition category
Condition code
Musculoskeletal
0
0
0
0
Query!
Osteoarthritis
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Rheumatoid arthritis
Query!
Intervention/exposure
Study type
Interventional(has expanded access)
Query!
Description of intervention(s) / exposure
Treatment: Other - Certolizumab Pegol
Experimental: Certolizumab Pegol - All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.
Treatment: Other: Certolizumab Pegol
Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.
Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.
Duration: Until end of study.
Query!
Intervention code [1]
0
0
Treatment: Other
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percentage of Subjects With at Least One Adverse Event (AE) From First Certolizumab Pegol (CZP) Dose up to Approximately 7 Years
Query!
Assessment method [1]
0
0
An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage.
First dose of Certolizumab Pegol (CZP) was at Baseline of the preceding double-blind study \[NCT00152386\] for subjects randomized to CZP, or at Entry Visit (Week 0) of this study for subjects randomized to Placebo.
Query!
Timepoint [1]
0
0
From first dose of CZP to the end of the open-label study (approximately 7 years)
Query!
Primary outcome [2]
0
0
Percentage of Subjects With at Least One Serious Adverse Event (SAE) From First Certolizumab Pegol (CZP) Dose up to Approximately 7 Years
Query!
Assessment method [2]
0
0
A SAE is any untoward medical occurrence that at any dose:
* Results in death
* Is life-threatening
* Requires in patient hospitalisation or prolongation of existing hospitalisation
* Results in persistent or significant disability/incapacity, or
* Is a congenital anomaly or birth defect
* Is as infection that requires treatment parenteral antibiotics
* Other important medical events which based on medical or scientific judgement may jeopardise the patients, or may require medical or surgical intervention to prevent any of the above
First dose of CZP was at Baseline of the preceding double-blind study \[NCT00152386\] for subjects randomized to CZP, or at Entry Visit (Week 0) of this study for subjects randomized to Placebo.
Query!
Timepoint [2]
0
0
From first dose of CZP to the end of the open-label study (approximately 7 years)
Query!
Primary outcome [3]
0
0
Percentage of Subjects Who Withdrew Due to an Adverse Event (AE) During the Study
Query!
Assessment method [3]
0
0
An AE is any untoward medical occurrence in a subject or trial subject that is administered a drug or biologic (medicinal product) or that is using a medical device. The event does not necessarily have a causal relationship with that treatment or usage. The results of this Primary Outcome Measure are summarized from the Adverse Event pages of the Case Report Forms.
Query!
Timepoint [3]
0
0
From Entry Visit (Week 0) to the end of the study (approximately 6.5 years)
Query!
Secondary outcome [1]
0
0
Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 48
Query!
Assessment method [1]
0
0
The assessments are based on a 20 % or greater improvement from Baseline to Week 48 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Query!
Timepoint [1]
0
0
From Baseline of the preceding double-blind study to Week 48 of the open-label study
Query!
Secondary outcome [2]
0
0
Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 96
Query!
Assessment method [2]
0
0
The assessments are based on a 20 % or greater improvement from Baseline to Week 96 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Query!
Timepoint [2]
0
0
From Baseline of the preceding double-blind study to Week 96 of the open-label study
Query!
Secondary outcome [3]
0
0
Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 144
Query!
Assessment method [3]
0
0
The assessments are based on a 20 % or greater improvement from Baseline to Week 144 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Query!
Timepoint [3]
0
0
From Baseline of the preceding double-blind study to Week 144 of the open-label study
Query!
Secondary outcome [4]
0
0
Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 192
Query!
Assessment method [4]
0
0
The assessments are based on a 20 % or greater improvement from Baseline to Week 192 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Query!
Timepoint [4]
0
0
From Baseline of the preceding double-blind study to Week 192 of the open-label study
Query!
Secondary outcome [5]
0
0
Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 240
Query!
Assessment method [5]
0
0
The assessments are based on a 20 % or greater improvement from Baseline to Week 240 in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Query!
Timepoint [5]
0
0
From Baseline of the preceding double-blind study to Week 240 of the open-label study
Query!
Secondary outcome [6]
0
0
Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Completion/Withdrawal
Query!
Assessment method [6]
0
0
The assessments are based on a 20 % or greater improvement from Baseline to Completion/Withdrawal in the number of tender joints, a 20 % or more improvement in the number of swollen joints, and a 20 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Query!
Timepoint [6]
0
0
From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)
Query!
Secondary outcome [7]
0
0
Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 48
Query!
Assessment method [7]
0
0
The assessments are based on a 50 % or greater improvement from Baseline to Week 48 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Query!
Timepoint [7]
0
0
From Baseline of the preceding double-blind study to Week 48 of the open-label study
Query!
Secondary outcome [8]
0
0
Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 96
Query!
Assessment method [8]
0
0
The assessments are based on a 50 % or greater improvement from Baseline to Week 96 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Query!
Timepoint [8]
0
0
From Baseline of the preceding double-blind study to Week 96 of the open-label study
Query!
Secondary outcome [9]
0
0
Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 144
Query!
Assessment method [9]
0
0
The assessments are based on a 50 % or greater improvement from Baseline to Week 144 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Query!
Timepoint [9]
0
0
From Baseline of the preceding double-blind study to Week 144 of the open-label study
Query!
Secondary outcome [10]
0
0
Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 192
Query!
Assessment method [10]
0
0
The assessments are based on a 50 % or greater improvement from Baseline to Week 192 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Query!
Timepoint [10]
0
0
From Baseline of the preceding double-blind study to Week 192 of the open-label study
Query!
Secondary outcome [11]
0
0
Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 240
Query!
Assessment method [11]
0
0
The assessments are based on a 50 % or greater improvement from Baseline to Week 240 in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Query!
Timepoint [11]
0
0
From Baseline of the preceding double-blind study to Week 240 of the open-label study
Query!
Secondary outcome [12]
0
0
Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Completion/Withdrawal
Query!
Assessment method [12]
0
0
The assessments are based on a 50 % or greater improvement from Baseline to Completion/Withdrawal in the number of tender joints, a 50 % or more improvement in the number of swollen joints, and a 50 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Query!
Timepoint [12]
0
0
From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)
Query!
Secondary outcome [13]
0
0
Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 48
Query!
Assessment method [13]
0
0
The assessments are based on a 70 % or greater improvement from Baseline to Week 48 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Query!
Timepoint [13]
0
0
From Baseline of the preceding double-blind study to Week 48 of the open-label study
Query!
Secondary outcome [14]
0
0
Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 96
Query!
Assessment method [14]
0
0
The assessments are based on a 70 % or greater improvement from Baseline to Week 96 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Query!
Timepoint [14]
0
0
From Baseline of the preceding double-blind study to Week 96 of the open-label study
Query!
Secondary outcome [15]
0
0
Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 144
Query!
Assessment method [15]
0
0
The assessments are based on a 70 % or greater improvement from Baseline to Week 144 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Query!
Timepoint [15]
0
0
From Baseline of the preceding double-blind study to Week 144 of the open-label study
Query!
Secondary outcome [16]
0
0
Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 192
Query!
Assessment method [16]
0
0
The assessments are based on a 70 % or greater improvement from Baseline to Week 192 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Query!
Timepoint [16]
0
0
From Baseline of the preceding double-blind study to Week 192 of the open-label study
Query!
Secondary outcome [17]
0
0
Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 240
Query!
Assessment method [17]
0
0
The assessments are based on a 70 % or greater improvement from Baseline to Week 240 in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Query!
Timepoint [17]
0
0
From Baseline of the preceding double-blind study to Week 240 of the open-label study
Query!
Secondary outcome [18]
0
0
Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Completion/Withdrawal
Query!
Assessment method [18]
0
0
The assessments are based on a 70 % or greater improvement from Baseline to Completion/Withdrawal in the number of tender joints, a 70 % or more improvement in the number of swollen joints, and a 70 % or greater improvement in 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP). Baseline is Baseline of the preceding double-blind study.
Query!
Timepoint [18]
0
0
From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)
Query!
Secondary outcome [19]
0
0
Change From Baseline of the Preceding Double-Blind Study to Week 96 in Modified Total Sharp Score (mTSS)
Query!
Assessment method [19]
0
0
The mTSS quantifies the extent of bone erosions and joint space narrowing for 44 and 42 joints, respectively, as assessed by x-rays of the hands and feet. The score ranges from 0 to 448 with higher scores representing greater damage. A negative value in mTSS change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Query!
Timepoint [19]
0
0
From Baseline of the preceding double-blind study to Week 96 of the open-label study
Query!
Secondary outcome [20]
0
0
Change From Baseline of the Preceding Double-Blind Study to Completion/Withdrawal Visit in Health Assessment Questionnaire - Disability Index (HAQ-DI) Total Score
Query!
Assessment method [20]
0
0
The HAQ-DI assesses the degree of difficulty experienced in eight domains (Dressing and Grooming, Arising, Eating, Walking, Hygiene, Reach, Gripping, Other Activities) of daily living activities using 20 questions. The HAQ-DI is calculated by summing the domain scores and dividing them by the number of domains. It ranges from 0 (no difficulty) to 3 (unable to do). Negative values indicate an improvement from Baseline to the Post-Baseline Visit with larger negative values showing a better improvement.
Query!
Timepoint [20]
0
0
From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)
Query!
Secondary outcome [21]
0
0
Change From Baseline to Completion/Withdrawal Visit in Duration of Morning Stiffness
Query!
Assessment method [21]
0
0
Morning stiffness is defined as the time in hours elapsed between the time of usual awakening (even if not in the morning) and the time the subject is as limber as he/she will be during a day involving typical activities. A negative value in duration of morning stiffness change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement.
Query!
Timepoint [21]
0
0
From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)
Query!
Secondary outcome [22]
0
0
Change From Baseline to Completion/Withdrawal Visit in Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28[ESR])
Query!
Assessment method [22]
0
0
DAS28\[ESR\] is calculated using the Tender Joint Count (TJC), Swollen Joint Count (SJC) Erythrocyte Sedimentation Rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x v(TJC) + 0.28 x v(SJC) + 0.70 x lognat (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. A negative value in DAS28\[ESR\] change from Baseline indicates an improvement from Baseline.
Query!
Timepoint [22]
0
0
From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)
Query!
Secondary outcome [23]
0
0
Percentage of Subjects With Good European League Against Rheumatism (EULAR) Response at Completion/Withdrawal Visit
Query!
Assessment method [23]
0
0
Good EULAR response is defined as Disease Activity Score 28 \[Erythrocyte Sedimentation Rate\] (DAS28\[ESR\]) improvement from Baseline of the preceding double-blind study \> 1.2 and DAS28\[ESR\] value \< 3.2.
Query!
Timepoint [23]
0
0
From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)
Query!
Secondary outcome [24]
0
0
Change From Baseline to Completion/Withdrawal Visit in Short-Form Health Survey (SF-36) Item Questionnaire Physical Component Summary (PCS) Score
Query!
Assessment method [24]
0
0
The SF-36 is a 36-item generic health status measure that measures 8 general health concepts: Physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each domain of the eight domains and the summary concept PCS score are scored to yield values between 0 (worst) and 100 (best).
Query!
Timepoint [24]
0
0
From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)
Query!
Secondary outcome [25]
0
0
Change From Baseline to Completion/Withdrawal Visit in Short-Form Health Survey (SF-36) Item Questionnaire Mental Component Summary (MCS) Score
Query!
Assessment method [25]
0
0
The SF-36 is a 36-item generic health status measure that measures 8 general health concepts: Physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each domain of the eight domains and the summary concept MCS score are scored to yield values between 0 (worst) and 100 (best).
Query!
Timepoint [25]
0
0
From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 7 years)
Query!
Eligibility
Key inclusion criteria
Patients must have either failed to achieve American College of Rheumatology 20 % Response Criteria (ACR20) at Weeks 12 and 14 in C87027 [NCT00152386], or must have completed the entire Week 52 assessment of C87027 [NCT00152386] trial.
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
* A diagnosis of any other inflammatory Arthritis (e.g. Psoriatic Arthritis or Ankylosing Spondylitis)
* A secondary, non-inflammatory type of Arthritis (e.g. Osteoarthritis or Fibromyalgia) that in the Investigator's opinion is symptomatic enough to interfere with evaluation of the effect of CDP870 on the patient's primary diagnosis of Rheumatoid Arthritis
* Any concomitant biological therapy
* Any experimental therapy, within or outside a clinical trial
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
NA
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
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Phase 3
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
1/06/2005
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/02/2012
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
857
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
18 - Malvern
Query!
Recruitment hospital [2]
0
0
21 - Maroochydore
Query!
Recruitment hospital [3]
0
0
23 - Perth
Query!
Recruitment postcode(s) [1]
0
0
- Malvern
Query!
Recruitment postcode(s) [2]
0
0
- Maroochydore
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
Connecticut
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
Idaho
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
Maryland
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Missouri
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Nebraska
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
North Carolina
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Ohio
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
South Carolina
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Texas
Query!
Country [14]
0
0
Argentina
Query!
State/province [14]
0
0
Buenos Aires
Query!
Country [15]
0
0
Argentina
Query!
State/province [15]
0
0
Capital Federal
Query!
Country [16]
0
0
Argentina
Query!
State/province [16]
0
0
Ciudad Autonoma de Buenos Aire
Query!
Country [17]
0
0
Argentina
Query!
State/province [17]
0
0
Cordoba
Query!
Country [18]
0
0
Argentina
Query!
State/province [18]
0
0
Quilmes
Query!
Country [19]
0
0
Argentina
Query!
State/province [19]
0
0
Rosario
Query!
Country [20]
0
0
Argentina
Query!
State/province [20]
0
0
San Miguel de Tucuman
Query!
Country [21]
0
0
Argentina
Query!
State/province [21]
0
0
Santa Fe
Query!
Country [22]
0
0
Belgium
Query!
State/province [22]
0
0
Antwerpen
Query!
Country [23]
0
0
Belgium
Query!
State/province [23]
0
0
Liege
Query!
Country [24]
0
0
Belgium
Query!
State/province [24]
0
0
Merksem
Query!
Country [25]
0
0
Bulgaria
Query!
State/province [25]
0
0
Pleven
Query!
Country [26]
0
0
Bulgaria
Query!
State/province [26]
0
0
Sofia
Query!
Country [27]
0
0
Bulgaria
Query!
State/province [27]
0
0
Stara Zagora
Query!
Country [28]
0
0
Canada
Query!
State/province [28]
0
0
Ontario
Query!
Country [29]
0
0
Canada
Query!
State/province [29]
0
0
Hamilton
Query!
Country [30]
0
0
Canada
Query!
State/province [30]
0
0
Kitchener
Query!
Country [31]
0
0
Canada
Query!
State/province [31]
0
0
Pointe Claire
Query!
Country [32]
0
0
Canada
Query!
State/province [32]
0
0
Sainte Foy
Query!
Country [33]
0
0
Canada
Query!
State/province [33]
0
0
Winnipeg
Query!
Country [34]
0
0
Chile
Query!
State/province [34]
0
0
Santiago de Chile
Query!
Country [35]
0
0
Chile
Query!
State/province [35]
0
0
Valdivia
Query!
Country [36]
0
0
Croatia
Query!
State/province [36]
0
0
Rijeka
Query!
Country [37]
0
0
Czechia
Query!
State/province [37]
0
0
Brno
Query!
Country [38]
0
0
Czechia
Query!
State/province [38]
0
0
Ostrava Trebovice
Query!
Country [39]
0
0
Czechia
Query!
State/province [39]
0
0
Plzen
Query!
Country [40]
0
0
Czechia
Query!
State/province [40]
0
0
Praha 2
Query!
Country [41]
0
0
Czechia
Query!
State/province [41]
0
0
Praha 5
Query!
Country [42]
0
0
Czechia
Query!
State/province [42]
0
0
Praha
Query!
Country [43]
0
0
Czechia
Query!
State/province [43]
0
0
Uherske Hradiste
Query!
Country [44]
0
0
Czechia
Query!
State/province [44]
0
0
Zlin
Query!
Country [45]
0
0
Estonia
Query!
State/province [45]
0
0
Parnu
Query!
Country [46]
0
0
Estonia
Query!
State/province [46]
0
0
Tallinn
Query!
Country [47]
0
0
Estonia
Query!
State/province [47]
0
0
Tartu
Query!
Country [48]
0
0
Finland
Query!
State/province [48]
0
0
Hyvinkaa
Query!
Country [49]
0
0
France
Query!
State/province [49]
0
0
Montpellier Cedex 5
Query!
Country [50]
0
0
Hungary
Query!
State/province [50]
0
0
Budapest
Query!
Country [51]
0
0
Hungary
Query!
State/province [51]
0
0
Bupadest
Query!
Country [52]
0
0
Hungary
Query!
State/province [52]
0
0
Debrecen
Query!
Country [53]
0
0
Hungary
Query!
State/province [53]
0
0
Miskolc
Query!
Country [54]
0
0
Hungary
Query!
State/province [54]
0
0
Szolnok
Query!
Country [55]
0
0
Israel
Query!
State/province [55]
0
0
Afula
Query!
Country [56]
0
0
Israel
Query!
State/province [56]
0
0
Ashkelon
Query!
Country [57]
0
0
Israel
Query!
State/province [57]
0
0
Haifa
Query!
Country [58]
0
0
Israel
Query!
State/province [58]
0
0
Ramat Gan
Query!
Country [59]
0
0
Israel
Query!
State/province [59]
0
0
Tel Aviv
Query!
Country [60]
0
0
Israel
Query!
State/province [60]
0
0
Zerifin
Query!
Country [61]
0
0
Latvia
Query!
State/province [61]
0
0
Riga
Query!
Country [62]
0
0
Lithuania
Query!
State/province [62]
0
0
Alytus
Query!
Country [63]
0
0
Lithuania
Query!
State/province [63]
0
0
Kaunas
Query!
Country [64]
0
0
Lithuania
Query!
State/province [64]
0
0
Klaipeda
Query!
Country [65]
0
0
Lithuania
Query!
State/province [65]
0
0
Panevezys
Query!
Country [66]
0
0
Lithuania
Query!
State/province [66]
0
0
Siauliai
Query!
Country [67]
0
0
Lithuania
Query!
State/province [67]
0
0
Vilnius
Query!
Country [68]
0
0
Mexico
Query!
State/province [68]
0
0
Mexicalli
Query!
Country [69]
0
0
Mexico
Query!
State/province [69]
0
0
Monterrey
Query!
Country [70]
0
0
New Zealand
Query!
State/province [70]
0
0
Auckland
Query!
Country [71]
0
0
New Zealand
Query!
State/province [71]
0
0
Christchurch
Query!
Country [72]
0
0
New Zealand
Query!
State/province [72]
0
0
South Canterbury
Query!
Country [73]
0
0
New Zealand
Query!
State/province [73]
0
0
Tauranga
Query!
Country [74]
0
0
Russian Federation
Query!
State/province [74]
0
0
Moscow
Query!
Country [75]
0
0
Russian Federation
Query!
State/province [75]
0
0
St. Petersburg
Query!
Country [76]
0
0
Russian Federation
Query!
State/province [76]
0
0
Yaroslavl
Query!
Country [77]
0
0
Serbia
Query!
State/province [77]
0
0
Belgrade
Query!
Country [78]
0
0
Serbia
Query!
State/province [78]
0
0
Niska Banja
Query!
Country [79]
0
0
Serbia
Query!
State/province [79]
0
0
Novi Sad
Query!
Country [80]
0
0
Slovakia
Query!
State/province [80]
0
0
Bratislava
Query!
Country [81]
0
0
Slovakia
Query!
State/province [81]
0
0
Kosice
Query!
Country [82]
0
0
Slovakia
Query!
State/province [82]
0
0
Piestany
Query!
Country [83]
0
0
Ukraine
Query!
State/province [83]
0
0
Dnepropetrovsk
Query!
Country [84]
0
0
Ukraine
Query!
State/province [84]
0
0
Donetsk
Query!
Country [85]
0
0
Ukraine
Query!
State/province [85]
0
0
Ivano-Frankivsk
Query!
Country [86]
0
0
Ukraine
Query!
State/province [86]
0
0
Kiev
Query!
Country [87]
0
0
Ukraine
Query!
State/province [87]
0
0
Symferopyl
Query!
Country [88]
0
0
Ukraine
Query!
State/province [88]
0
0
Zaporozhye
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
UCB Pharma
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
An open ended study in which patients who completed the double-blind study CDP870-027 \[NCT00152386\] are given Certolizumab Pegol (CZP) and assessed for signs and symptoms of Rheumatoid Arthritis (RA).
Query!
Trial website
https://clinicaltrials.gov/study/NCT00175877
Query!
Trial related presentations / publications
Paul S, Marotte H, Kavanaugh A, Goupille P, Kvien TK, de Longueville M, Mulleman D, Sandborn WJ, Vande Casteele N. Exposure-Response Relationship of Certolizumab Pegol and Achievement of Low Disease Activity and Remission in Patients With Rheumatoid Arthritis. Clin Transl Sci. 2020 Jul;13(4):743-751. doi: 10.1111/cts.12760. Epub 2020 Apr 1. Keystone EC, Combe B, Smolen J, Strand V, Goel N, van Vollenhoven R, Mease P, Landewe R, Fleischmann R, Luijtens K, van der Heijde D. Sustained efficacy of certolizumab pegol added to methotrexate in the treatment of rheumatoid arthritis: 2-year results from the RAPID 1 trial. Rheumatology (Oxford). 2012 Sep;51(9):1628-38. doi: 10.1093/rheumatology/kes082. Epub 2012 May 16. van der Heijde D, Keystone EC, Curtis JR, Landewe RB, Schiff MH, Khanna D, Kvien TK, Ionescu L, Gervitz LM, Davies OR, Luijtens K, Furst DE. Timing and magnitude of initial change in disease activity score 28 predicts the likelihood of achieving low disease activity at 1 year in rheumatoid arthritis patients treated with certolizumab pegol: a post-hoc analysis of the RAPID 1 trial. J Rheumatol. 2012 Jul;39(7):1326-33. doi: 10.3899/jrheum.111171. Epub 2012 May 15. Curtis JR, Chen L, Luijtens K, Navarro-Millan I, Goel N, Gervitz L, Weinblatt M. Dose escalation of certolizumab pegol from 200 mg to 400 mg every other week provides no additional efficacy in rheumatoid arthritis: an analysis of individual patient-level data. Arthritis Rheum. 2011 Aug;63(8):2203-8. doi: 10.1002/art.30387. Curtis JR, Winthrop K, O'Brien C, Ndlovu MN, de Longueville M, Haraoui B. Use of a baseline risk score to identify the risk of serious infectious events in patients with rheumatoid arthritis during certolizumab pegol treatment. Arthritis Res Ther. 2017 Dec 15;19(1):276. doi: 10.1186/s13075-017-1466-y. Smolen J, Landewe RB, Mease P, Brzezicki J, Mason D, Luijtens K, van Vollenhoven RF, Kavanaugh A, Schiff M, Burmester GR, Strand V, Vencovsky J, van der Heijde D. Efficacy and safety of certolizumab pegol plus methotrexate in active rheumatoid arthritis: the RAPID 2 study. A randomised controlled trial. Ann Rheum Dis. 2009 Jun;68(6):797-804. doi: 10.1136/ard.2008.101659. Epub 2008 Nov 17.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
UCB Clinical Trial Call Center
Query!
Address
0
0
+1 877 822 9493 (UCB)
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
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
Type
Citations or Other Details
Journal
Keystone EC, Combe B, Smolen J, Strand V, Goel N, ...
[
More Details
]
Journal
van der Heijde D, Keystone EC, Curtis JR, Landewe ...
[
More Details
]
Journal
Curtis JR, Chen L, Luijtens K, Navarro-Millan I, G...
[
More Details
]
Results are available at
https://clinicaltrials.gov/study/NCT00175877
Download to PDF