A Study of RoActemra/Actemra (Tocilizumab) Versus Placebo in Patients With Systemic Sclerosis

Completed · Phase 3 · Has a placebo group

Conditions studied: Sclerosis, Systemic

In brief

This multicenter, randomized, double-blind, placebo-controlled, two-arm, parallel-group study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in participants with systemic sclerosis. Participants will be randomized to receive either RoActemra/Actemra 162 mg subcutaneously weekly or placebo for 48 weeks. From Week 48 to Week 96, all participants will receive open-label RoActemra/Actemra 162 mg subcutaneously weekly. Anticipated time on study treatment is 96 weeks.

Key facts

Study ID

NCT01532869

Run by

Hoffmann-La Roche

People needed

87

Starts

2012-03-01

Expected to finish

2015-08-01

Last updated by the study team

2016-09-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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

Where it is running

• Study site — Los Angeles, California, United States
• Study site — San Diego, California, United States
• Study site — Stanford, California, United States
• Study site — Farmington, Connecticut, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Chicago, Illinois, United States
• Study site — Baltimore, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — New Brunswick, New Jersey, United States
• Study site — Lake Success, New York, United States
• Study site — New York, New York, United States
• Study site — Cleveland, Ohio, United States
• Study site — Toledo, Ohio, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Charleston, South Carolina, United States
• Study site — Houston, Texas, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Seattle, Washington, United States
• Study site — London, Ontario, Canada
• Study site — Toronto, Ontario, Canada
• Study site — Montreal, Quebec, Canada
• Study site — Bordeaux, France

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.