Conditions: Rheumatoid Arthritis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 96
Healthy volunteers: no

Brief summary:
This randomized, parallel-group study will assess the efficacy and safety of RoActemra/Actemra (tocilizumab) versus adalimumab, both in combination with methotrexate (MTX) in patients with moderate to severe active rheumatoid arthritis. Patients, already treated with MTX at stable doses, will be randomized to receive either RoActemra/Actemra 8 mg/kg intravenously (IV) every 4 weeks or adalimumab 40 mg subcutaneous (SC) every 2 weeks. All patients will receive methotrexate (10-25 mg weekly) and folate (at least 5 mg weekly). The anticipated time on study treatment is 24 weeks.

Detailed description:

Arms:
arm 1: Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly. arm 2: Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.

Interventions: intervention 1: tocilizumab [RoActemra/Actemra] intervention 2: adalimumab intervention 3: placebo to tocilizumab intervention 4: placebo to adalimumab intervention 5: methotrexate intervention 6: folate
Intervention descriptions: intervention 1: Tocilizumab 8 mg/kg IV every 4 weeks for 24 weeks. intervention 2: Adalimumab 40 mg SC every 2 weeks. intervention 3: Placebo to tocilizumab IV every 4 weeks for 24 weeks. intervention 4: Placebo to adalimumab SC every 2 weeks for 24 weeks. intervention 5: Methotrexate 10-25 mg weekly. intervention 6: Folate at least 5 mg weekly.

Protocol document: