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

Part of paid clinical trials in El Cajon, California.

Sponsor
Hoffmann-La Roche
Study ID
NCT02453256
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Nov 20, 2015
Status verified
Mar 2020
Primary completion
Jan 15, 2018
Completion
Feb 4, 2019

Study Design

Enrollment
212 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Double-Blind Placebo
    Participants will receive double-blind matching placebo from Baseline to Week 47. Participants may then receive open-label tocilizumab from Weeks 48 to 96.
  • Experimental: Double-Blind Tocilizumab
    Participants will receive double-blind tocilizumab from Baseline to Week 47. Participants may then receive open-label tocilizumab from Weeks 48 to 96.

Primary Outcome Measure

Change in Modified Rodnan Skin Score (mRSS) During Double-blind Period [ Time Frame: From baseline to week 48 ]

Locations (16)

FacilityCityStateZIPSite coordinators
TriWest Research Associates, LLCEl CajonCalifornia92020-
St. Joseph's Heritage HealthcareFullertonCalifornia92835-
Arthritis Associates of Southern CaliforniaLos AngelesCalifornia90045-
Univ of Calif., Los Angeles; RheumatologyLos AngelesCalifornia90025-
Georgetown Uni. Hosp.; Rheumatology, Immunology and Allergy Dept.Washington D.C.District of Columbia20007-
Rheumatology Assoc. of S. Florida - Clinical Research CenterBoca RatonFlorida33486-
Millenium ResearchOrmond BeachFlorida32174-
Boston Univ Med Center - ACBostonMassachusetts02118-
University of MichiganAnn ArborMichigan48109-0934-
West Michigan Rheumatology, PLLCGrand RapidsMichigan49546-
Joint & Muscle Research InstituteCharlotteNorth Carolina28204-
Arthritis and Rheumatology; Center of Oklahoma PLLCOklahoma CityOklahoma73103-
Thomas Jefferson Uni ; Division of RheumatologyPhiladelphiaPennsylvania19131-
Clinical Research Center of ReadingWyomissingPennsylvania19610-
West Tennessee Research InstituteJacksonTennessee38305-
Metroplex Clinical ResearchDallasTexas75231-

Find similar trials in El Cajon, CA

By research site
TriWest Research Associates, LLC· El Cajon, CASt. Joseph's Heritage Healthcare· Fullerton, CAArthritis Associates of Southern California· Los Angeles, CAUniv of Calif., Los Angeles; Rheumatology· Los Angeles, CAGeorgetown Uni. Hosp.; Rheumatology, Immunology and Allergy Dept.· Washington D.C., DCRheumatology Assoc. of S. Florida - Clinical Research Center· Boca Raton, FL

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