At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II/III, Multicenter, Randomized, Double-blind, Placebo-controlled Study To Assess The Efficacy And Safety Of Tocilizumab Versus Placebo In Patients With Systemic Sclerosis
In Brief
A Phase 3 clinical trial evaluating Placebo and tocilizumab [RoActemra/Actemra] for Sclerosis, Systemic. Completed, enrolled 87 participants across 50 sites in 5 countries.
Detailed 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.
Study Details
Timeline
Interventions
Subcutaneously weekly, Weeks 0-48
162 mg subcutaneously weekly, Weeks 0-48
162 mg subcutaneously weekly, Week 48-96