A Study of the Efficacy and Safety of Tocilizumab in Participants With Systemic Sclerosis (SSc)
Condition: Systemic Sclerosis
MeSH terms: Scleroderma, Systemic; Scleroderma, Diffuse; Sclerosis
Intervention: Placebo; Tocilizumab
Intervention description: Participants will receive matching placebo subcutaneous (SC) injections once weekly for 48 weeks of double-blind treatment.; 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.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 212.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

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