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Search / Trial NCT01532869

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.

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

0 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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