A Study of RoActemra/Actemra (Tocilizumab) Versus Placebo in Patients With Systemic Sclerosis
Launched by HOFFMANN-LA ROCHE · Feb 14, 2012
Trial Information
Current as of June 20, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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
- Exclusion Criteria:
- • 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
About Hoffmann La Roche
Hoffmann-La Roche, commonly known as Roche, is a global leader in biotechnology and pharmaceuticals, committed to advancing healthcare through innovative research and development. With a strong focus on oncology, immunology, infectious diseases, and central nervous system disorders, Roche leverages cutting-edge science to deliver transformative therapies and diagnostics. The company is dedicated to improving patient outcomes by conducting rigorous clinical trials and collaborating with healthcare professionals and organizations worldwide. Roche's unwavering commitment to precision medicine and personalized healthcare positions it at the forefront of the industry, driving progress in the quest for effective treatments and improved patient care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Cleveland, Ohio, United States
Edinburgh, , United Kingdom
Los Angeles, California, United States
London, , United Kingdom
Chicago, Illinois, United States
Baltimore, Maryland, United States
Chicago, Illinois, United States
Seattle, Washington, United States
Montreal, Quebec, Canada
Washington, District Of Columbia, United States
Salt Lake City, Utah, United States
Oklahoma City, Oklahoma, United States
New Brunswick, New Jersey, United States
Houston, Texas, United States
New York, New York, United States
Baltimore, Maryland, United States
Caen, , France
Newcastle Upon Tyne, , United Kingdom
Salt Lake City, Utah, United States
Toronto, Ontario, Canada
Bochum, , Germany
Erlangen, , Germany
Paris, , France
Bordeaux, , France
Tübingen, , Germany
Strasbourg, , France
Dundee, , United Kingdom
Farmington, Connecticut, United States
Boston, Massachusetts, United States
Lille, , France
Köln, , Germany
Toledo, Ohio, United States
Ulm, , Germany
Washington, District Of Columbia, United States
Pittsburgh, Pennsylvania, United States
Oklahoma City, Oklahoma, United States
London, Ontario, Canada
Dresden, , Germany
Cannock, , United Kingdom
Liverpool, , United Kingdom
Middlesborough, , United Kingdom
Lake Success, New York, United States
Bad Nauheim, , Germany
Baden Baden, , Germany
Toulouse, , France
Leeds, , United Kingdom
Charleston, South Carolina, United States
Hamburg, , Germany
Philadelphia, Pennsylvania, United States
Frankfurt, , Germany
San Diego, California, United States
Romford, , United Kingdom
Ann Arbor, Michigan, United States
Stanford, California, United States
Berlin, , Germany
Patients applied
Trial Officials
Clinical Trials
Study Director
Hoffmann-La Roche
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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