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Sponsors and Collaborators: |
Elan Pharmaceuticals Biogen Idec |
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Information provided by: | Elan Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00083759 |
The purpose of this study is to determine the safety, tolerability and efficacy of natalizumab in subjects diagnosed with moderate to severe rheumatoid arthritis (RA) receiving concomitant treatment with methotrexate (MTX). It is thought that natalizumab may stop the movement of certain white blood cells, known as lymphocytes, into joint tissue. These cells are thought to cause damage in the joints leading to the symptoms of RA.
Condition | Intervention | Phase |
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Rheumatoid Arthritis |
Drug: natalizumab Drug: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II, Multicenter, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, and Tolerability of Intravenous Natalizumab (300 mg) in Subjects With Moderate to Severe Rheumatoid Arthritis (RA) Receiving Concomitant Treatment With Methotrexate (MTX) |
Enrollment: | 299 |
Study Start Date: | May 2004 |
Estimated Study Completion Date: | September 2005 |
Primary Completion Date: | February 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
natalizumab: Active Comparator | Drug: natalizumab |
placebo: Placebo Comparator | Drug: placebo |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects will be eligible to begin study participation if they meet all of the following inclusion criteria:
Exclusion Criteria:
Subjects will be excluded from the study if they meet any of the following exclusion criteria:
United States, Alabama | |
University of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35294 | |
United States, Arizona | |
Clinical Research Unit / University of Arizona | |
Tucson, Arizona, United States, 85719 | |
United States, California | |
Arthritis Medical Clinic of North County, Inc. | |
Escondido, California, United States, 92025-4402 | |
United States, Florida | |
Jacksonville Center for Clinical Research | |
Jacksonville, Florida, United States, 32216 | |
United States, Maine | |
Massachusetts General Hospital | |
Boston, Maine, United States, 02114 | |
United States, Massachusetts | |
Clinical Pharmacology Study Group | |
Worcester, Massachusetts, United States, 01610 | |
United States, Michigan | |
Justus Fiechtner, MD, PC | |
Lansing, Michigan, United States, 48910 | |
United States, Pennsylvania | |
Rheumatic Disease Associates | |
Willow Grove, Pennsylvania, United States, 19090 | |
Altoona Center for Clinical Research | |
Duncansville, Pennsylvania, United States, 16635 | |
United States, Texas | |
Radiant Research | |
Dallas, Texas, United States, 75235 | |
Canada, Newfoundland and Labrador | |
St. Clare's Mercy Hospital | |
St. John's, Newfoundland and Labrador, Canada, A1C 5B8 | |
Canada, Ontario | |
The Arthritis Program Research Group Inc. | |
Newmarket, Ontario, Canada, L3Y 3R7 |
Study ID Numbers: | ELN100226-RA201 |
Study First Received: | June 1, 2004 |
Results First Received: | January 27, 2009 |
Last Updated: | June 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00083759 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Antimetabolites Autoimmune Diseases Immunologic Factors Joint Diseases Arthritis, Rheumatoid Folate Rheumatic Diseases Folinic Acid Folic Acid Antagonists |
Immunosuppressive Agents Vitamin B9 Folic Acid Musculoskeletal Diseases Arthritis Connective Tissue Diseases Methotrexate Antirheumatic Agents |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Arthritis, Rheumatoid Reproductive Control Agents Musculoskeletal Diseases Arthritis Therapeutic Uses Abortifacient Agents Connective Tissue Diseases |
Methotrexate Dermatologic Agents Nucleic Acid Synthesis Inhibitors Autoimmune Diseases Immune System Diseases Joint Diseases Enzyme Inhibitors Rheumatic Diseases Abortifacient Agents, Nonsteroidal Folic Acid Antagonists Immunosuppressive Agents Pharmacologic Actions Antirheumatic Agents |