NCT01532869

A Study of RoActemra/Actemra (Tocilizumab) Versus Placebo in Patients With Systemic Sclerosis

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sclerosis, Systemic

Interventions

Type	Name	Description
DRUG	Placebo	Subcutaneously weekly, Weeks 0-48
DRUG	tocilizumab [RoActemra/Actemra]	162 mg subcutaneously weekly, Weeks 0-48
DRUG	tocilizumab [RoActemra/Actemra]	162 mg subcutaneously weekly, Week 48-96

Timeline

• Start date: 2012-03-01
• Primary completion: 2014-01-01
• Completion: 2015-08-01
• First posted: 2012-02-15
• Last updated: 2016-09-23
• Results posted: 2015-11-05

Locations

50 sites across 5 countries: United States, Canada, France, Germany, United Kingdom