Efficacy and Safety of CDP870 and Methotrexate Compared to Methotrexate Alone in Subjects With Rheumatoid Arthritis

UCB

Status and phase: Completed; Phase 3

Conditions: Arthritis, Rheumatoid

Treatments: Drug: CDP870

Study type: Interventional

Funder types: Industry

Identifiers

NCT00544154

C87014

Details and patient eligibility

About

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.

Enrollment: 247 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind