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A Study of the Safety and Effectiveness of Liquid Certolizumab Pegol in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis

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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00160641
Recruitment Status : Completed
First Posted : September 12, 2005
Results First Posted : March 7, 2013
Last Update Posted : March 27, 2020
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Tracking Information
First Submitted Date  ICMJE September 8, 2005
First Posted Date  ICMJE September 12, 2005
Results First Submitted Date  ICMJE January 31, 2013
Results First Posted Date  ICMJE March 7, 2013
Last Update Posted Date March 27, 2020
Study Start Date  ICMJE November 2005
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2013)
  • Percentage of Subjects With at Least One Adverse Event (AE) From First Certolizumab Pegol (CZP) Dose up to Approximately 6.8 Years [ Time Frame: From first dose of CZP to the end of the open-label study (approximately 6.8 years) ]
    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 CZP was at Baseline of the preceding double-blind study NCT00160602 for subjects randomized to CZP, or at Entry Visit (Week 0) of this study for subjects randomized to Placebo.
  • Percentage of Subjects With at Least One Serious Adverse Event (SAE) From First Certolizumab Pegol (CZP) Dose up to Approximately 6.8 Years [ Time Frame: From first dose of CZP to the end of the open-label study (approximately 6.8 years) ]
    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 NCT00160602 for subjects randomized to CZP, or at Entry Visit (Week 0) of this study for subjects randomized to Placebo.
  • Percentage of Subjects Who Withdrew Due to an Adverse Event (AE) During the Study [ Time Frame: From Entry Visit (Week 0) to the end of the study (approximately 6.3 years) ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 8, 2005)
To assess the safety of the liquid formulation of certolizumab pegol, dosed at 400mg s.c. every two weeks, in patients with active rheumatoid arthritis (RA) by measuring ACR 20/50/70 responder rates every 12 weeks
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2013)
  • Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 52 [ Time Frame: From Baseline of the preceding double-blind study to Week 52 of the open-label study ]
    The assessments are based on a 20 % or greater improvement from Baseline to Week 52 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.
  • Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 100 [ Time Frame: From Baseline of the preceding double-blind study to Week 100 of the open-label study ]
    The assessments are based on a 20 % or greater improvement from Baseline to Week 100 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.
  • Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 148 [ Time Frame: From Baseline of the preceding double-blind study to Week 148 of the open-label study ]
    The assessments are based on a 20 % or greater improvement from Baseline to Week 148 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.
  • Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 196 [ Time Frame: From Baseline of the preceding double-blind study to Week 196 of the open-label study ]
    The assessments are based on a 20 % or greater improvement from Baseline to Week 196 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.
  • Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 244 [ Time Frame: From Baseline of the preceding double-blind study to Week 244 of the open-label study ]
    The assessments are based on a 20 % or greater improvement from Baseline to Week 244 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.
  • Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Completion/Withdrawal [ Time Frame: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years) ]
    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.
  • Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 52 [ Time Frame: From Baseline of the preceding double-blind study to Week 52 of the open-label study ]
    The assessments are based on a 50 % or greater improvement from Baseline to Week 52 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.
  • Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 100 [ Time Frame: From Baseline of the preceding double-blind study to Week 100 of the open-label study ]
    The assessments are based on a 50 % or greater improvement from Baseline to Week 100 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.
  • Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 148 [ Time Frame: From Baseline of the preceding double-blind study to Week 148 of the open-label study ]
    The assessments are based on a 50 % or greater improvement from Baseline to Week 148 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.
  • Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 196 [ Time Frame: From Baseline of the preceding double-blind study to Week 196 of the open-label study ]
    The assessments are based on a 50 % or greater improvement from Baseline to Week 196 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.
  • Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 244 [ Time Frame: From Baseline of the preceding double-blind study to Week 244 of the open-label study ]
    The assessments are based on a 50 % or greater improvement from Baseline to Week 244 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.
  • Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Completion/Withdrawal [ Time Frame: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years) ]
    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.
  • Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 52 [ Time Frame: From Baseline of the preceding double-blind study to Week 52 of the open-label study ]
    The assessments are based on a 70 % or greater improvement from Baseline to Week 52 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.
  • Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 100 [ Time Frame: From Baseline of the preceding double-blind study to Week 100 of the open-label study ]
    The assessments are based on a 70 % or greater improvement from Baseline to Week 100 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.
  • Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 148 [ Time Frame: From Baseline of the preceding double-blind study to Week 148 of the open-label study ]
    The assessments are based on a 70 % or greater improvement from Baseline to Week 148 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.
  • Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 196 [ Time Frame: From Baseline of the preceding double-blind study to Week 196 of the open-label study ]
    The assessments are based on a 70 % or greater improvement from Baseline to Week 196 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.
  • Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 244 [ Time Frame: From Baseline of the preceding double-blind study to Week 244 of the open-label study ]
    The assessments are based on a 70 % or greater improvement from Baseline to Week 244 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.
  • Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Completion/Withdrawal [ Time Frame: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years) ]
    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.
  • Change From Baseline of the Preceding Double-Blind Study to Week 104 in Modified Total Sharp Score (mTSS) [ Time Frame: From Baseline of the preceding double-blind study to Week 104 of the open-label study ]
    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.
  • Change From Baseline of the Preceding Double-Blind Study to Completion/Withdrawal Visit in Health Assessment Questionnaire - Disability Index (HAQ-DI) Total Score [ Time Frame: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years) ]
    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.
  • Change From Baseline to Completion/Withdrawal Visit in Duration of Morning Stiffness [ Time Frame: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years) ]
    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.
  • Change From Baseline to Completion/Withdrawal Visit in Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28[ESR]) [ Time Frame: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years) ]
    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 √(TJC) + 0.28 x √(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.
  • Percentage of Subjects With Good European League Against Rheumatism (EULAR) Response at Completion/Withdrawal Visit [ Time Frame: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years) ]
    Good EULAR response is defined as DAS28[ESR] improvement from Baseline of the preceding double-blind study > 1.2 and DAS28[ESR] value < 3.2.
  • Change From Baseline to Completion/Withdrawal Visit in Short-Form Health Survey (SF-36) Item Questionnaire Physical Component Summary (PCS) Score [ Time Frame: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years) ]
    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).
  • Change From Baseline to Completion/Withdrawal Visit in Short-Form Health Survey (SF-36) Item Questionnaire Mental Component Summary (MCS) Score [ Time Frame: From Baseline of the preceding double-blind study to Completion/Withdrawal of the open-label study (up to approximately 6.8 years) ]
    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).
Original Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2005)
  • To assess the tolerability and efficacy of liquid certolizumab pegol dosed at 400mg every two weeks in patients with active RA.
  • To assess the effect of liquid certolizumab pegol dosed at 400mg every two weeks on physical function and Health Outcome measures.
  • To monitor the pharmacokinetic and immunogenicity profile of liquid certolizumab pegol
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of the Safety and Effectiveness of Liquid Certolizumab Pegol in the Treatment of Signs and Symptoms of Rheumatoid Arthritis and in Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis
Official Title  ICMJE A Phase III Multi-center, Open-label, Follow-up Study, to Assess the Safety and Efficacy of Liquid Certolizumab Pegol as Additional Medication to Methotrexate, in the Treatment of Signs and Symptoms and in the Prevention of Joint Damage in Patients With Active Rheumatoid Arthritis Who Participated in Study CDP870-050
Brief Summary An open ended study in which patients who completed the preceding double-blind study NCT00160602 are given Certolizumab Pegol and assessed for signs and symptoms of Rheumatoid Arthritis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE Biological: Certolizumab Pegol

Strength and Form: 1 ml of Liquid product 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.

Other Name: Cimzia
Study Arms  ICMJE 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.
Intervention: Biological: Certolizumab Pegol
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 10, 2013)
567
Original Enrollment  ICMJE
 (submitted: September 8, 2005)
450
Actual Study Completion Date  ICMJE February 2012
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Patients must have either failed to achieve an American College of Rheumatology 20 % (ACR20) response at Weeks 12 and 14 in C87050 [NCT00160602], or must have completed the entire Week 24 assessment of C87050 [NCT00160602] trial.

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 (RA)
  • Any concomitant biological therapy
  • Any experimental therapy, within or outside a clinical
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   Croatia,   Czechia,   Estonia,   Israel,   Latvia,   Lithuania,   Poland,   Russian Federation,   Serbia,   Slovakia,   Ukraine,   United States
Removed Location Countries Czech Republic,   Former Serbia and Montenegro
 
Administrative Information
NCT Number  ICMJE NCT00160641
Other Study ID Numbers  ICMJE C87051
2005-002629-30 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party UCB Pharma
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE UCB Pharma
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
PRS Account UCB Pharma
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP