CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 212 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Tocilizumab 162 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02453256
NCT02453256Phase 3Completed
CompareCT.gov

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of Tocilizumab Versus Placebo in Patients With Systemic Sclerosis

Hoffmann-La Roche·interventional·Posted May 25, 2015·Updated Mar 9, 2020

In Brief

A Phase 3 clinical trial evaluating Placebo and Tocilizumab for Systemic Sclerosis. Completed, enrolled 212 participants across 83 sites in 22 countries.

Detailed Summary

This study will assess the efficacy and safety of tocilizumab compared with placebo in participants with SSc across approximately 120 planned global study sites. The study will consist of a 48-week, double-blind, placebo-controlled period followed by a 48-week open-label treatment period. Participants will be assigned, in a 1:1 ratio, to double-blind treatment with active tocilizumab or matching placebo. In the open-label period, eligible participants from either arm may receive active tocilizumab.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSystemic Sclerosis
CountriesArgentina, Belgium, Bulgaria, Canada, Denmark, France, Germany, Greece, Hungary, Italy, Japan, Lithuania, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Romania, Spain, Switzerland, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 25, 2015
Enrollment StartNov 20, 2015
Primary CompletionJan 15, 2018
Study CompletionFeb 4, 2019
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 11.1 years ago

Interventions

Placebodrug

Participants will receive matching placebo subcutaneous (SC) injections once weekly for 48 weeks of double-blind treatment.

Tocilizumabdrug

Participants will receive 162 mg SC tocilizumab once weekly for 48 weeks of double-blind treatment. The same regimen will be given to all eligible participants for 48 weeks of open-label treatment.