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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 manifestation)

- >/= 15 and

- 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

Page last updated: August 23, 2015

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