A Study of the Efficacy and Safety of Tocilizumab in Participants With Systemic Sclerosis (SSc) (FocuSSced)
- Autoimmune Disorder
- Systemic Sclerosis
- Puerto Rico
- United Kingdom
- United States
NCT02453256 2015-000424-28 WA29767
Clinical Trial Results
Once the last participant has completed the clinical trial, Roche will analyze the combined results of the trial and create a report summarizing the results. The analysis of the data takes time; however Roche aims to make the summary of the outcome of the clinical trial available within 12 months after the last clinical trial participant has completed the trial. Roche may also provide a summary of trial outcome prior to the end of the clinical trial. Below you can find the available results of the FocuSSced clinical trial.
The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.
The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
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.
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
- 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
- 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
For the latest version of this information please go to www.forpatients.roche.com