Efficacy and Safety of CDP870 Versus Placebo in the Treatment of the Signs and Symptoms of Rheumatoid Arthritis
1 other identifier
interventional
220
0 countries
N/A
Brief Summary
The purpose of this study was to confirm and extend the data from previous studies and to demonstrate the efficacy (in terms of signs and symptoms) and safety of monotherapy with CDP870 administered SC every 4 weeks compared to placebo in patients with active RA who had failed at least one DMARD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 rheumatoid-arthritis
Started Jun 2003
Shorter than P25 for phase_3 rheumatoid-arthritis
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
October 15, 2007
CompletedFirst Posted
Study publicly available on registry
October 24, 2007
CompletedSeptember 4, 2013
February 1, 2010
1.1 years
October 15, 2007
September 3, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
American College of Rheumatology (ACR)-20 responder rate at Week 24
24 weeks
Secondary Outcomes (3)
safety and tolerability every 4 weeks
Every 4 weeks
effect of CDP870 on health outcomes measures
24 weeks
systemic exposures and immunogenic profile of CDP870
24 weeks
Interventions
Eligibility Criteria
You may qualify if:
- male/female, 18-75 years old, inclusive
- diagnosis of adult-onset RA
- had active disease
- had received methotrexate
- on a stable dose of folic acid
You may not qualify if:
- contraindication for methotrexate or anti-TNF
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UCB Pharmalead
Related Publications (1)
Fleischmann R, Vencovsky J, van Vollenhoven RF, Borenstein D, Box J, Coteur G, Goel N, Brezinschek HP, Innes A, Strand V. Efficacy and safety of certolizumab pegol monotherapy every 4 weeks in patients with rheumatoid arthritis failing previous disease-modifying antirheumatic therapy: the FAST4WARD study. Ann Rheum Dis. 2009 Jun;68(6):805-11. doi: 10.1136/ard.2008.099291. Epub 2008 Nov 17.
PMID: 19015206RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
UCB Clinical Trial Call Center
UCB Pharma
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 15, 2007
First Posted
October 24, 2007
Study Start
June 1, 2003
Primary Completion
July 1, 2004
Study Completion
July 1, 2004
Last Updated
September 4, 2013
Record last verified: 2010-02