Conditions: Rheumatoid Arthritis
Keywords: CDP870 Korea CIMZIA
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 127
Healthy volunteers: no

Brief summary:
The objective of this trial is to compare the efficacy of Certolizumab (CZP) (CDP870) in combination with Methotrexate (MTX) to MTX alone in the treatment of signs and symptoms in patients with active rheumatoid arthritis (RA) who are incomplete responders to MTX.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Placebo of CDP870 intervention 2: CDP870 200mg intervention 3: Methotrexate
Intervention descriptions: intervention 1: 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 Week 22(SC) intervention 3: Received treatment with Methotrexate(MTX)for at least 24 weeks prior to the Baseline Visit.

The dose and route of administration of MTX had to have been stable for at least 8 weeks prior to the Baseline Visit. The minimum stable dose of MTX allowed is 10mg weekly.

Protocol document: