Conditions: Rheumatoid Arthritis
Keywords: Certolizumab Pegol Cimzia Adalimumab Humira Rheumatoid Arthritis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 915
Healthy volunteers: no

Brief summary:
This study is conducted to evaluate the short (12 Weeks) and long term (104 Weeks) efficacy of Certolizumab Pegol compared with Adalimumab both in combination with Methotrexate (MTX) in the treatment of moderate to severe Rheumatoid Arthritis (RA) that is not responding adequately to MTX.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: Those subjects who received Certolizumab Pegol (400 mg at Weeks 0, 2, 4 followed by 200 mg every two weeks) + Methotrexate (CZP+ MTX) at Baseline and are Non-Responders at Week 12, switch to Adalimumab (40 mg) + Methotrexate (ADA + MTX) after Week 12. arm 4: Those subjects who received Adalimumab (40 mg + Placebo at Weeks 0, 2, 4 followed by 40 mg ADA every two weeks) + Methotrexate (ADA+ MTX) at Baseline and are Non-Responders at Week 12, switch to Certolizumab Pegol (400 mg at Weeks 12, 14, 16 followed by 200 mg every two weeks) + Methotrexate (CZP+ MTX) after Week 12.

Interventions: intervention 1: Certolizumab Pegol (CZP) intervention 2: Adalimumab (ADA) intervention 3: Methotrexate (MTX)
Intervention descriptions: intervention 1: * Active substance: an injectable volume of 1 ml solution for injection CZP
* Pharmaceutical form: prefilled syringes CZP
* Concentration: 200 mg/ml CZP
* Route of Administration: injections will be given subcutaneously: loading dose of CZP 400 mg at Baseline, and Weeks 2 and 4, followed by a maintenance dose of 200 mg every 2 weeks through Week 102 or withdrawal. intervention 2: * Active substance: an injectable volume of 0.8 ml solution for injection ADA
* Pharmaceutical form: prefilled syringes ADA
* Concentration: 40 mg/0.8 ml ADA
* Route of Administration: injections will be given subcutaneously. ADA 40 mg plus an injection with Placebo (to preserve blind) at Baseline, and Weeks 2 and 4, followed by ADA 40 mg every 2 weeks through Week 102 or withdrawal. intervention 3: * Active substance: Methotrexate
* Pharmaceutical form: oral tablet
* Concentration: 15-25 mg/week
* Route of Administration: MTX orally

Protocol document: