A Study of RoActemra/Actemra (Tocilizumab) Versus Placebo in Patients With Systemic Sclerosis
NCT ID: NCT01532869
Last Updated: 2016-09-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
87 participants
INTERVENTIONAL
2012-03-31
2015-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Placebo
Subcutaneously weekly, Weeks 0-48
tocilizumab [RoActemra/Actemra]
162 mg subcutaneously weekly, Week 48-96
Tocilizumab
tocilizumab [RoActemra/Actemra]
162 mg subcutaneously weekly, Weeks 0-48
tocilizumab [RoActemra/Actemra]
162 mg subcutaneously weekly, Week 48-96
Interventions
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Placebo
Subcutaneously weekly, Weeks 0-48
tocilizumab [RoActemra/Actemra]
162 mg subcutaneously weekly, Weeks 0-48
tocilizumab [RoActemra/Actemra]
162 mg subcutaneously weekly, Week 48-96
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Los Angeles, California, United States
San Diego, California, United States
Stanford, California, United States
Farmington, Connecticut, United States
Washington D.C., District of Columbia, United States
Chicago, Illinois, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
New Brunswick, New Jersey, United States
Lake Success, New York, United States
New York, New York, United States
Cleveland, Ohio, United States
Toledo, Ohio, United States
Oklahoma City, Oklahoma, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Charleston, South Carolina, United States
Houston, Texas, United States
Salt Lake City, Utah, United States
Seattle, Washington, United States
London, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Bordeaux, , France
Caen, , France
Lille, , France
Paris, , France
Strasbourg, , France
Toulouse, , France
Bad Nauheim, , Germany
Baden-Baden, , Germany
Berlin, , Germany
Bochum, , Germany
Cologne, , Germany
Dresden, , Germany
Erlangen, , Germany
Frankfurt, , Germany
Hamburg, , Germany
Tübingen, , Germany
Ulm, , Germany
Cannock, , United Kingdom
Dundee, , United Kingdom
Edinburgh, , United Kingdom
Leeds, , United Kingdom
Liverpool, , United Kingdom
London, , United Kingdom
Middlesbrough, , United Kingdom
Newcastle upon Tyne, , United Kingdom
Romford, , United Kingdom
Countries
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References
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Gao X, Jia G, Guttman A, DePianto DJ, Morshead KB, Sun KH, Ramamoorthi N, Vander Heiden JA, Modrusan Z, Wolters PJ, Jahreis A, Arron JR, Khanna D, Ramalingam TR. Osteopontin Links Myeloid Activation and Disease Progression in Systemic Sclerosis. Cell Rep Med. 2020 Nov 17;1(8):100140. doi: 10.1016/j.xcrm.2020.100140. eCollection 2020 Nov 17.
Stifano G, Sornasse T, Rice LM, Na L, Chen-Harris H, Khanna D, Jahreis A, Zhang Y, Siegel J, Lafyatis R. Skin Gene Expression Is Prognostic for the Trajectory of Skin Disease in Patients With Diffuse Cutaneous Systemic Sclerosis. Arthritis Rheumatol. 2018 Jun;70(6):912-919. doi: 10.1002/art.40455.
Denton CP, Ong VH, Xu S, Chen-Harris H, Modrusan Z, Lafyatis R, Khanna D, Jahreis A, Siegel J, Sornasse T. Therapeutic interleukin-6 blockade reverses transforming growth factor-beta pathway activation in dermal fibroblasts: insights from the faSScinate clinical trial in systemic sclerosis. Ann Rheum Dis. 2018 Sep;77(9):1362-1371. doi: 10.1136/annrheumdis-2018-213031. Epub 2018 May 31.
Khanna D, Denton CP, Lin CJF, van Laar JM, Frech TM, Anderson ME, Baron M, Chung L, Fierlbeck G, Lakshminarayanan S, Allanore Y, Pope JE, Riemekasten G, Steen V, Muller-Ladner U, Spotswood H, Burke L, Siegel J, Jahreis A, Furst DE. Safety and efficacy of subcutaneous tocilizumab in systemic sclerosis: results from the open-label period of a phase II randomised controlled trial (faSScinate). Ann Rheum Dis. 2018 Feb;77(2):212-220. doi: 10.1136/annrheumdis-2017-211682. Epub 2017 Oct 24.
Khanna D, Denton CP, Jahreis A, van Laar JM, Frech TM, Anderson ME, Baron M, Chung L, Fierlbeck G, Lakshminarayanan S, Allanore Y, Pope JE, Riemekasten G, Steen V, Muller-Ladner U, Lafyatis R, Stifano G, Spotswood H, Chen-Harris H, Dziadek S, Morimoto A, Sornasse T, Siegel J, Furst DE. Safety and efficacy of subcutaneous tocilizumab in adults with systemic sclerosis (faSScinate): a phase 2, randomised, controlled trial. Lancet. 2016 Jun 25;387(10038):2630-2640. doi: 10.1016/S0140-6736(16)00232-4. Epub 2016 May 5.
Other Identifiers
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2011-001460-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
WA27788
Identifier Type: -
Identifier Source: org_study_id
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