Arthritis, Rheumatoid Clinical Trial
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
Verified date | September 2009 |
Source | UCB Pharma |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Paul-Ehrlich-Institut |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 247 |
Est. completion date | January 2004 |
Est. primary completion date | January 2004 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
UCB Pharma |
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):12 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | American college of Rheumatolofy (ACR)-20 responder rate at Week 24 | |||
Secondary | Safety and tolerability | |||
Secondary | health outcomes measures | |||
Secondary | immunogenic profile of CDP870 plus methotrexate | |||
Secondary | systemic exposure of CDP870 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
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