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

Completed · Phase 3 · Has a placebo group

Conditions studied: Systemic Sclerosis

In brief

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 facts

Study ID

NCT02453256

Run by

Hoffmann-La Roche

People needed

212

Starts

2015-11-20

Expected to finish

2019-02-04

Last updated by the study team

2020-03-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of SSc according to American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR) criteria, meeting criteria for active disease and with total disease duration of less than or equal to (</=) 60 months
• mRSS of 10-35 units, inclusive
• Agreement to remain abstinent or use an effective contraceptive method among males and females with childbearing potential

You may not qualify if…

• Pregnant or lactating females
• Major surgery within 8 weeks prior to screening
• Scleroderma limited to the face or areas distal to the elbows or knees
• Rheumatic autoimmune disease other than SSc
• Immunization with a live or attenuated vaccine within 4 weeks prior to Baseline
• Known hypersensitivity to human, humanized, or murine monoclonal antibodies
• Moderately severe nervous system, renal, endocrine, pulmonary, cardiovascular, or gastrointestinal (GI) disease not related to SSc, including diverticulitis or ulcerative lower GI disorders, or myocardial infarction (MI) within 6 months prior to screening
• Active or significant history of infection, including treatment with intravenous (IV) antibiotics within 4 weeks or oral antibiotics within 2 weeks prior to screening
• Significant history of tuberculosis (TB)
• Primary or secondary immunodeficiency
• Malignant disease, with the exception of excised/cured local basal or squamous cell carcinoma of the skin or carcinoma in situ of the uterine cervix
• History of drug or alcohol abuse

Where it is running

• St. Joseph's Heritage Healthcare — Fullerton, California, United States
• Univ of Calif., Los Angeles; Rheumatology — Los Angeles, California, United States
• Arthritis Associates of Southern California — Los Angeles, California, United States
• Georgetown Uni. Hosp.; Rheumatology, Immunology and Allergy Dept. — Washington D.C., District of Columbia, United States
• Rheumatology Assoc. of S. Florida - Clinical Research Center — Boca Raton, Florida, United States
• Millenium Research — Ormond Beach, Florida, United States
• Boston Univ Med Center - AC — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• West Michigan Rheumatology, PLLC — Grand Rapids, Michigan, United States
• Joint & Muscle Research Institute — Charlotte, North Carolina, United States
• Arthritis and Rheumatology; Center of Oklahoma PLLC — Oklahoma City, Oklahoma, United States
• Thomas Jefferson Uni ; Division of Rheumatology — Philadelphia, Pennsylvania, United States
• Clinical Research Center of Reading — Wyomissing, Pennsylvania, United States
• West Tennessee Research Institute — Jackson, Tennessee, United States
• Metroplex Clinical Research — Dallas, Texas, United States
• Organizacion Medica de Investigacion — Buenos Aires, Argentina
• Hospital Britanico; Haematology — Buenos Aires, Argentina
• Sanatorio Parque S.A. — Rosario, Santa FE, Argentina
• Centro de Investigaciones Reumatologicas Tucuman — San Miguel de Tucumán, Argentina
• UZ Gent — Ghent, Belgium
• UZ Leuven Gasthuisberg — Leuven, Belgium
• MHAT Kaspela; Rheumatology — Plovdiv, Bulgaria
• MHAT-Plovdiv AD; Reumatology Department — Plovdiv, Bulgaria
• MHAT St.Ivan Rilski; Rheumtology Department — Sofia, Bulgaria
• TriWest Research Associates, LLC — El Cajon, California, United States

Full record on ClinicalTrials.gov

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