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Sponsored by: |
MedImmune LLC |
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Information provided by: | MedImmune LLC |
ClinicalTrials.gov Identifier: | NCT00069017 |
To compare, as a preliminary analysis, the effects of MEDI-522 versus placebo at 6 months on disease activity (ACR20) and progression of structural joint damage.
Condition | Intervention | Phase |
---|---|---|
Rheumatoid Arthritis |
Biological: MEDI-522 Other: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Efficacy Study |
Official Title: | A Phase II, Randomized, Double-Blind Study to Evaluate the Effects of MEDI-522, a Humanized MAb to Integrin Alpha V Beta 3, On Disease Activity and Progression of Joint Damage in Pts With Active Rheumatoid Arthritis Suboptimally Responding to Methotrexate |
Enrollment: | 300 |
Study Start Date: | September 2003 |
Study Completion Date: | April 2006 |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
MEDI-522 - 4 mg/kg of MEDI-522 (N=200)
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Biological: MEDI-522
MEDI-522 is formulated in a sterile isotonic solution of 10 mM histidine-HCl at pH 6 containing 100 mg of MEDI-522 protein at a concentration of 100 mg/mL.
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2: Placebo Comparator
Placebo (N=100)
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Other: Placebo
Placebo for MEDI-522 contains 10 mM histidine-HCl at pH 6, 0.1% Tween-80, 1.5% Mannitol, 4.3 µg/mL Vitamin B12, and 2 µg/mL D&C Yellow #10.
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To compare, as a preliminary analysis, the effects of subcutaneously administered MEDI-522 versus placebo at 6 months on disease activity and progression of structural joint damage in patients with rheumatoid arthritis (RA), who have active disease despite ongoing treatment with methotrexate (MTX) with or without hydroxychloroquine (HCQ) and/or sulfasalazine (SSZ).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Patients must meet all of the following criteria:
Exclusion Criteria
Patients must have none of the following:
Study ID Numbers: | MI-CP100 |
Study First Received: | September 12, 2003 |
Last Updated: | November 26, 2007 |
ClinicalTrials.gov Identifier: | NCT00069017 |
Health Authority: | United States: Food and Drug Administration |
Autoimmune Diseases Joint Diseases Hydroxocobalamin Arthritis, Rheumatoid Disease Progression Vitamin B 12 Rheumatic Diseases |
Folic Acid Musculoskeletal Diseases Mannitol Arthritis Connective Tissue Diseases Methotrexate |
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Immune System Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Reproductive Control Agents |
Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Immunosuppressive Agents Pharmacologic Actions Therapeutic Uses Abortifacient Agents Antirheumatic Agents Dermatologic Agents Nucleic Acid Synthesis Inhibitors |