Conditions: Sclerosis, Systemic
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 87
Healthy volunteers: no

Brief summary:
This multicenter, randomized, double-blind, placebo-controlled, two-arm, parallel-group study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in participants with systemic sclerosis. Participants will be randomized to receive either RoActemra/Actemra 162 mg subcutaneously weekly or placebo for 48 weeks. From Week 48 to Week 96, all participants will receive open-label RoActemra/Actemra 162 mg subcutaneously weekly. Anticipated time on study treatment is 96 weeks.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Placebo intervention 2: tocilizumab [RoActemra/Actemra] intervention 3: tocilizumab [RoActemra/Actemra]
Intervention descriptions: intervention 1: Subcutaneously weekly, Weeks 0-48 intervention 2: 162 mg subcutaneously weekly, Weeks 0-48 intervention 3: 162 mg subcutaneously weekly, Week 48-96

Protocol document: