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| Sponsor: | MedImmune LLC |
|---|---|
| Information provided by: | MedImmune LLC |
| ClinicalTrials.gov Identifier: | NCT00069017 |
Purpose
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: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
|---|---|
|
Active Comparator: 1
MEDI-522 - 4 mg/kg of MEDI-522 (N=200)
|
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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Placebo Comparator: 2
Placebo (N=100)
|
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).
Eligibility| 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:
Contacts and Locations
Show 40 Study Locations
More Information
| ClinicalTrials.gov Identifier: | NCT00069017 History of Changes |
| Other Study ID Numbers: | MI-CP100 |
| Study First Received: | September 12, 2003 |
| Last Updated: | November 26, 2007 |
| Health Authority: | United States: Food and Drug Administration |
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Methotrexate Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs |
Pharmacologic Actions Therapeutic Uses Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors |