A Study of RoActemra/Actemra (Tocilizumab) Versus Placebo in Patients With Systemic Sclerosis
Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sclerosis, Systemic
Intervention: Placebo (Drug); tocilizumab [RoActemra/Actemra] (Drug); tocilizumab [RoActemra/Actemra] (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Hoffmann-La Roche Official(s) and/or principal investigator(s): Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche
Summary
This multicenter, randomized, double-blind, placebo-controlled, two-arm, parallel-group
study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in patients
with systemic sclerosis. Patients will be randomized to receive either RoActemra/Actemra 162
mg subcutaneously weekly or placebo for 48 weeks. From Week 49 to Week 96, all patients will
receive open-label RoActemra/Actemra 162 mg subcutaneously weekly. Anticipated time on study
treatment is 96 weeks.
Clinical Details
Official title: A PHASE II/III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Change in modified Rodnan skin score (mRSS)Safety: Incidence of adverse events
Secondary outcome: Change in physical function, assessed by Scleroderma Health Assessment Questionnaire-Disability Index (SHAQ-DI)Change in joint tenderness, assessed by 28 tender joint count (TJC), in patients with joint involvement at baseline Pharmacokinetics: Area under the concentration--time curve (AUC) Pharmacodynamics: sIL-6R/IL-6 levels Immunogenicity: anti-tocilizumab antibody level
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Bordeaux 33075, France
Caen 14033, France
Lille 59037, France
Paris 75679, France
Strasbourg 67091, France
Toulouse 31000, France
Bad Nauheim 61231, Germany
Baden-Baden 76530, Germany
Berlin 10177, Germany
Bochum 44791, Germany
Dresden 01067, Germany
Erlangen 91054, Germany
Frankfurt 60528, Germany
Hamburg 22763, Germany
Köln 50937, Germany
Tübingen 72076, Germany
Ulm 89081, Germany
Cannock WS11 5XY, United Kingdom
Dundee DD1 9SY, United Kingdom
Edinburgh EX4 2HU, United Kingdom
Leeds LS7 4SA, United Kingdom
Liverpool L9 7AL, United Kingdom
London NW3 2QG, United Kingdom
Middlesborough TS4 3BW, United Kingdom
Newcastle Upon Tyne NE7 7DN, United Kingdom
Romford RM7 0AG, United Kingdom
Los Angeles, California 90025, United States
San Diego, California 44122, United States
Stanford, California 94305-5317, United States
Farmington, Connecticut 06030, United States
Washington, District of Columbia 20007, United States
Chicago, Illinois 60611, United States
Baltimore, Maryland 21224, United States
Boston, Massachusetts 02118, United States
Ann Arbor, Michigan 48109-0934, United States
New Brunswick, New Jersey 08903, United States
Lake Success, New York 11042, United States
New York, New York 10021, United States
Cleveland, Ohio 44195, United States
Toledo, Ohio 43614, United States
Oklahoma City, Oklahoma 73103, United States
London, Ontario N6A 4V2, Canada
Toronto, Ontario M5G 1X5, Canada
Philadelphia, Pennsylvania 19131, United States
Pittsburgh, Pennsylvania 15261, United States
Montreal, Quebec H3T 1E2, Canada
Charleston, South Carolina 29425, United States
Houston, Texas 77030, United States
Salt Lake City, Utah 84132, United States
Seattle, Washington 98104, United States
Additional Information
Starting date: March 2012
Last updated: July 1, 2015
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