Conditions: Rheumatoid Arthritis
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 162
Healthy volunteers: no

Brief summary:
This open-label study will evaluate the efficacy and safety of tocilizumab as monotherapy or in combination with methotrexate or other non-biologic disease modifying anti-rheumatic drugs (DMARDs) in participants with active rheumatoid arthritis (RA) and an inadequate response to current non-biologic DMARD therapy or the first anti-tumour necrosis factor (anti-TNF) agent. Participants will receive tocilizumab 162 milligrams (mg) subcutaneously once a week for 52 weeks.

Detailed description:

Arms:
arm 1: Participants will receive a weekly SC injection of tocilizumab 162 mg as monotherapy for 52 weeks. arm 2: Participants will receive a weekly SC injection of tocilizumab 162 mg in combination with methotrexate or other non-biologic DMARDs for 52 weeks.

Interventions: intervention 1: Tocilizumab intervention 2: DMARDs intervention 3: Oral Corticosteroids intervention 4: Methotrexate
Intervention descriptions: intervention 1: Tocilizumab 162 mg will be administered once a week by SC injection and as a single fixed dose, irrespective of body weight, for the treatment duration of 52 weeks. intervention 2: Treatment with non-biologic DMARDs, at a stable dose that was initiated at least 4 weeks prior to baseline, is permitted during the study. The study protocol does not specify any particular therapy. intervention 3: Stable oral corticosteroids doses (≤10 mg/day prednisone or equivalent) are allowed. The study protocol does not specify any additional detail on types of oral corticosteroids. intervention 4: Methotrexate per investigator's discretion.

Protocol document: