Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
