Conditions: Rheumatoid Arthritis
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 133
Healthy volunteers: no

Brief summary:
This Phase IIIb, open-label, single-arm study will evaluate the safety, efficacy, and tolerability of SC tocilizumab (RoActemra/Actemra) in monotherapy or in combination with methotrexate or other non-biologic DMARDs in participants with active RA who are naive to tocilizumab. Participants will receive tocilizumab 162 milligrams (mg) subcutaneously weekly (QW) for 24 weeks.

Detailed description:

Arms:
arm 1: All participants will receive tocilizumab as a single fixed dose (monotherapy) or in combination with methotrexate or other non-biologic DMARDs, irrespective of body weight, for 24 weeks.

Interventions: intervention 1: Tocilizumab intervention 2: Methotrexate intervention 3: Non-Biologic DMARDs
Intervention descriptions: intervention 1: Tocilizumab 162 mg will be administered subcutaneously QW. intervention 2: Methotrexate dosing is not specified by the protocol and will be given as per standard practice. Participants must be at a stable dose that was initiated at least 4 weeks prior to baseline. intervention 3: Participants will receive non-biologic DMARDs (same non-biologic DMARD that participant was receiving at time of study entry). Dosing is not specified by the protocol and will be given as per standard practice. Participants must be at a stable dose that was initiated at least 4 weeks prior to baseline.

Protocol document: