A clinical study conducted at many clinical sites. In this study patients will be randomly assigned to one of two treatments. Neither staff at the site nor the patient nor the sponsor’s team will know if the patient received drug with an active ingredient or drug without an active ingredient. The goal is to see if the drug improves the progression of the disease in patients with systemic sclerosis and what the side effects are.
- Conditions
- Systemic Sclerosis (SSc)MedDRA version: 17.0 Level: PT Classification code 10042953 Term: Systemic sclerosis System Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2011-001460-22-GB
- Lead Sponsor
- F. Hoffmann-La Roche Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 87
•Ability and willingness to give written informed consent and comply with the requirements of the study protocol
•Diagnosis of SSc, as defined using ACR criteria
•Disease duration of = 60 months (defined as time from the first non-Raynaud phenomenon manifestation)
•Age = 18 years
•= 15 and = 40 mRSS units at the screening visit
•Uninvolved skin at injection sites
•Active disease
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 66
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
•Rheumatic autoimmune disease other than SSc, including but not limited to, RA, systemic lupus erythematosis, mixed connective tissue disorder, polymyositis, dermatomyositis, eosinophilic fasciitis, primary Sjögren syndrome and eosinophilic myalgia syndrome
•Skin thickening (scleroderma) limited to areas distal to the elbows or knees at screening
•History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
•Evidence of moderately severe concomitant nervous system, renal, endocrine or GI disease, as determined by the Principal Investigator
•Pulmonary disease with FVC = 50% of predicted or a DLCO (hemoglobin corrected) = 40% of predicted
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method