Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT02453256

CompletedPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Systemic Sclerosis

Interventions: Placebo, Tocilizumab

Countries: United States, Argentina, Belgium, Bulgaria, Canada, Denmark, France, Germany

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
Locations (83)
  • El Cajon, California, United States
  • Fullerton, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Washington D.C., District of Columbia, United States
  • Boca Raton, Florida, United States
  • Ormond Beach, Florida, United States
  • Boston, Massachusetts, United States
  • Ann Arbor, Michigan, United States
  • Grand Rapids, Michigan, United States
  • Charlotte, North Carolina, United States
  • Oklahoma City, Oklahoma, United States
  • Philadelphia, Pennsylvania, United States
  • Wyomissing, Pennsylvania, United States
  • Jackson, Tennessee, United States
  • Dallas, Texas, United States
  • Buenos Aires, Argentina
  • Buenos Aires, Argentina
  • Rosario, Santa FE, Argentina
  • San Miguel de Tucumán, Argentina
  • Ghent, Belgium
  • Leuven, Belgium
  • Plovdiv, Bulgaria
  • Plovdiv, Bulgaria
  • Sofia, Bulgaria
  • Sofia, Bulgaria
  • Vancouver, British Columbia, Canada
  • Toronto, Ontario, Canada
  • Aarhus N, Denmark
  • København NV, Denmark
  • + 53 more on CT.gov