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
Adult patients, \>/= 18 years of age
Systemic sclerosis, as defined by American College of Rheumatology (1980) criteria
Disease duration of \</= 60 months (defined as time from first non-Raynaud phenomenon manifestation)
\>/= 15 and \</= 40 mRSS units at screening
Active disease, as defined by protocol
Uninvolved skin at injection sites
Negative pregnancy test for a female subject of childbearing potential
You may not be if
Major surgery (including joint surgery) within 8 weeks prior to and/or during study enrollment
Rheumatic autoimmune disease other than systemic sclerosis
Skin thickening (scleroderma) limited to areas distal to the elbows or knees at screening
Previous treatment with tocilizumab
History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
Severe cardiopulmonary disease
Known active current or history of recurrent infections
Use of any investigational, biologic, or immunosuppressive therapies including intra-articular or parenteral corticosteroids prior to study enrollment as specified in the protocol
As specified in the protocol, any current or past medical condition or medical history involving but not limited to the nervous, renal, pulmonary, endocrine, and gastrointestinal organ systems determined by the Principal Investigator to pose a significant safety risk to any subject while participating in the study
Primary or secondary immunodeficiency
Clareo Health | A Study of RoActemra/Actemra (Tocilizumab) Versus Placebo in Patients With Systemic Sclerosis
