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A Study of the Efficacy and Safety of Tocilizumab in Participants With Systemic Sclerosis (SSc) (FocuSSced)
- Autoimmunerkrankung
- Systemische Sklerose
Bitte beachten Sie, dass der Rekrutierungsstatus der Studie an Ihrem Standort vom Gesamtstatus der Studie abweichen kann, da einige Studienzentren früher rekrutieren als andere.
Status der Studie:
Abgeschlossen
Diese Studie läuft in
Städte
- Bad Abbach
- Bad Nauheim
- Dresden
- München
- Tübingen
Studien-ID:
NCT02453256 2015-000424-28 WA29767
Studienzusammenfassung
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.
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT02453256,WA29767,2015-000424-28
Studien-ID
Placebo, Tocilizumab
Treatments
Systemic Sclerosis
Condition
Official Title
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of Tocilizumab Versus Placebo in Patients With Systemic Sclerosis
Einschlusskriterien
All
Gender
≥18 Years
Age
No
Healthy Volunteers
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
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