Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis Certolizumab Pegol Cimzia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 316
Healthy volunteers: no

Brief summary:
The objective of this trial is to investigate the efficacy (American College of Rheumatology 20% : ACR20) superiority of two dose regiments of CDP870 versus placebo in combination with MTX in active RA patients who have an incomplete response to MTX. The pharmacokinetics and immunogenicity profile of CDP870 will also be investigated to assess the extrapolability of foreign data to the Japanese population.

Detailed description:

Arms:
arm 1: 200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks arm 2: 400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks arm 3: 400mg CDP870 given every 2 weeks arm 4: Placebo given every 2 weeks

Interventions: intervention 1: CDP870 400mg intervention 2: CDP870 200mg intervention 3: CDP870 100mg intervention 4: Placebo of CDP870
Intervention descriptions: intervention 1: 400mg CDP870 given every 2 weeks until Week22 (SC) intervention 2: 400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks until Week22 (SC) intervention 3: 200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks until Week22 subcutaneously(SC) intervention 4: given every 2 weeks until Week22 (SC)

Protocol document: