Systemic Sclerosis
Conditions
Sponsors
Chugai Pharmaceutical Co., Ltd.
F.Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Age >= 18 years at baseline (Day1) (2)Diagnosis of SSc, as defined using the American College of Rheumatology/EULAR criteria (3)SSc disease duration of == 10 and == 3 units compared with the most recent assessment performed within the previous 6 months -Involvement of one new body area and an increase in mRSS of >= 2 units compared with the most recent assessment performed within the previous 6 months -Involvement of two new body areas within the previous 6 months -Presence of at least one tendon friction rub (6)Uninvolved or mildly thickened skin at one of the following possible injection-site locations: -Front, middle region of the thigh -Abdomen, except for the 2-inch area directly around the navel -Outer area of the upper arm(if a patient caregiver is giving the injection)
Exclusion criteria
Exclusion criteria: (1)Skin thickening (scleroderma) limited to areas distal to the elbows or knees at screening (2)Rheumatic autoimmune disease other than SSc, including but not limited to RA (diagnosed using ACR/EULAR criteria), systemic lupus erythematosus, mixed connective tissue disorder, polymyositis, dermatomyositis, eosinophilic fasciitis, primary Sjogren's syndrome, and eosinophilic myalgia syndrome, as determined by the investigator (3)Previous treatment with anti-IL6 therapy (including and not limited to TCZ) (4)Treatment with cyclophosphamide within 6 months prior to baseline (5)Pulmonary disease with FVC =< 55% of predicted (best of three acceptable and repeatable measurements as described in the site's Pulmonary Function Testing Manual) OR DLCO =< 45% of predicted (corrected for hemoglobin, and the average of the 2 highest acceptable and repeatable measurements as described in the Pulmonary Function Testing Manual) (6)Class II or higher PAH, as defined by the World Health Organization (7)Treatment with non-investigational or investigational cell-depleting therapies, including but not limited to alemtuzumab, anti-CD4, anti-CD5, anti-CD3, anti-CD19,and anti-CD20 within 18 months of baseline; or if treatment prior to 18 months from baseline, evidence of peripheral depletion of targeted lymphocyte subset at screening (8)History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy The primary efficacy endpoint is the mean change in mRSS from baseline to Week 48. The primary analysis population for efficacy will be the ITT population, which includes all patients who are randomized and who receive any study drug. Patients in the ITT population will be grouped according to the treatment assigned at randomization. | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy (1)Difference in proportions of patients with >= 20%, >= 40%, and >= 60% improvement in mRSS at Week 48 compared with baseline (2)Difference in mean change in FVC from baseline to Week 48 (3)Difference in mean change in HAQ-DI from baseline to Week 48 (4)Difference in mean change in Patient's Global Assessment from baseline to Week 48 (5)Difference in mean change in Physician's Global Assessment from baseline to Week 48 (6)Time to treatment failure during the 48 week double-blind treatment period There is compared between the group of patients who received Tocilizumab 162 mg QW and the group of patients who received placebo. | — |
Countries
25 countries including Japan, US, UK, Germany etc., Europe, Japan, North America
Outcome results
None listed