Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis Certolizumab Pegol Cimzia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 230
Healthy volunteers: no

Brief summary:
The objectives of this study are to verify the superiority in efficacy (American College of Rheumatology 20%: ACR20) and investigate the pharmacokinetics and safety of CDP870 versus placebo without coadministration of MTX in active RA patients in whom MTX cannot be administrated.

Detailed description:

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

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

Protocol document: