Back to resultsEfficacy and Safety of CDP870 and Methotrexate Compared to Methotrexate Alone in Subjects With Rheumatoid Arthritis
Primary Purpose
Arthritis, Rheumatoid
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
CDP870
Sponsored by
About this trial
This is an interventional treatment trial for Arthritis, Rheumatoid focused on measuring CDP870, Certolizumab pegol
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- contraindication for methotrexate or anti-TNF
Sites / Locations
Outcomes
Primary Outcome Measures
American college of Rheumatolofy (ACR)-20 responder rate at Week 24
Secondary Outcome Measures
Safety and tolerability
health outcomes measures
immunogenic profile of CDP870 plus methotrexate
systemic exposure of CDP870
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00544154
Brief Title
Efficacy and Safety of CDP870 and Methotrexate Compared to Methotrexate Alone in Subjects With Rheumatoid Arthritis
Official Title
Efficacy and Safety of CDP870 400 mg in Combination With Methotrexate Compared to Methotrexate Alone in the Treatment of the Signs and Symptoms of Patients With Rheumatoid Arthritis Who Are Partial Responders to Methotrexate
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
January 2004 (Actual)
Study Completion Date
January 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
UCB Pharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main purpose of the study was to determine the efficacy of CDP870 in treating RA signs/symptoms in patients who were partial responders to MTX. Other purposes were to show additional efficacy without increased toxicity and the immunogenic response to CDP870 during combined CDP870 and MTX therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Rheumatoid
Keywords
CDP870, Certolizumab pegol
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
247 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
CDP870
Primary Outcome Measure Information:
Title
American college of Rheumatolofy (ACR)-20 responder rate at Week 24
Secondary Outcome Measure Information:
Title
Safety and tolerability
Title
health outcomes measures
Title
immunogenic profile of CDP870 plus methotrexate
Title
systemic exposure of CDP870
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
contraindication for methotrexate or anti-TNF
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
UCB Pharma
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
22344576
Citation
Choy E, McKenna F, Vencovsky J, Valente R, Goel N, Vanlunen B, Davies O, Stahl HD, Alten R. Certolizumab pegol plus MTX administered every 4 weeks is effective in patients with RA who are partial responders to MTX. Rheumatology (Oxford). 2012 Jul;51(7):1226-34. doi: 10.1093/rheumatology/ker519. Epub 2012 Feb 16.
Results Reference
result
Learn more about this trial
Efficacy and Safety of CDP870 and Methotrexate Compared to Methotrexate Alone in Subjects With Rheumatoid Arthritis
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