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A Study of the Efficacy and Safety of Tocilizumab in Participants With Systemic Sclerosis (SSc)

NCT02453256 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 212

Last updated 2020-03-09

Study results available
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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.

Conditions

Interventions

DRUG

Placebo

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

DRUG

Tocilizumab

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.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-20
Primary Completion
2018-01-15
Completion
2019-02-04
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Belgium
  • Bulgaria
  • Canada
  • Denmark
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Japan
  • Lithuania
  • Mexico
  • Netherlands
  • Poland
  • Portugal
  • Puerto Rico
  • Romania
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02453256 on ClinicalTrials.gov