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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: | 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)
|
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.
|
|
2: Placebo Comparator
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.
|
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
Hide Study Locations| United States, Alabama | |
| The University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35249-7201 | |
| United States, Arizona | |
| Arizona Research & Education | |
| Phoenix, Arizona, United States, 85012 | |
| Sun Valley Arthritis Center | |
| Glendale, Arizona, United States, 85308 | |
| University of Arizona | |
| Tucson, Arizona, United States, 85724 | |
| United States, Arkansas | |
| Fayetteville Diagnostic Clinic, Ltd. | |
| Fayetteville, Arkansas, United States, 72703 | |
| United States, California | |
| Boling Clinical Trials | |
| Rancho Cucamonga, California, United States, 91730 | |
| Pacific Arthritis Center Medical Group | |
| Santa Maria, California, United States, 93454 | |
| Thornton Hospital | |
| La Jolla, California, United States, 92037-0943 | |
| United States, Florida | |
| Arthritis and Rheumatic Disease Specialty | |
| Aventura, Florida, United States, 33180 | |
| Ocala Rheumatology Research Center | |
| Ocala, Florida, United States, 34474 | |
| Sarasota Arthritis Research Center | |
| Sarasota, Florida, United States, 34239 | |
| Centre for Rheumatology, Immunology & Arthritis | |
| Fort Lauderdale, Florida, United States, 33334 | |
| United States, Georgia | |
| Sanford S. Hartman | |
| Decatur, Georgia, United States, 30033 | |
| United States, Maryland | |
| Center for Rheumatology and Bone Research | |
| Wheaton, Maryland, United States, 20902 | |
| United States, Missouri | |
| Arthritis Consultants, Inc. | |
| St. Louis, Missouri, United States, 63141 | |
| RIMA | |
| St. Louis, Missouri, United States, 63131 | |
| United States, New Jersey | |
| Rheumatology Associates of New Jersey | |
| Teaneck, New Jersey, United States, 07666 | |
| United States, New York | |
| The Center for Rheumatology | |
| Albany, New York, United States, 12206 | |
| United States, Oklahoma | |
| Oklahoma Center for Arthritis Therapy and Research Inc. | |
| Tulsa, Oklahoma, United States, 74114 | |
| Lynn Health Science Institute | |
| Oklahoma City, Oklahoma, United States, 73112 | |
| Health Research Institute | |
| Oklahoma City, Oklahoma, United States, 73109 | |
| United States, Texas | |
| Radiant Research | |
| Dallas, Texas, United States, 75235 | |
| Amarillo Center for Clinical Research | |
| Amarillo, Texas, United States, 79124 | |
| Arthritis & Osteoporosis Associates, LLP | |
| Lubbock, Texas, United States, 79410 | |
| United States, Utah | |
| University of Utah Medical Hospital | |
| Salt Lake City, Utah, United States, 84132 | |
| United States, Washington | |
| Rheumatology Northwest/Clinical Trials Northwest | |
| Yakima, Washington, United States, 98902 | |
| The Physician's Clinic of Spokane | |
| Spokane, Washington, United States, 99204 | |
| United States, Wisconsin | |
| Gundersen Clinic Ltd. | |
| La Crosse, Wisconsin, United States, 54601 | |
| University of Wisconsin Hospital & Clinics | |
| Madison, Wisconsin, United States, 53792-3244 | |
| Canada, British Columbia | |
| Richmond Health Science Center | |
| Richmond, British Columbia, Canada, V7C 5L9 | |
| Canada, Manitoba | |
| Arthritis Centre | |
| Winnipeg, Manitoba, Canada, R3A 1M4 | |
| Manitoba Clinic | |
| Winnipeg, Manitoba, Canada, R3A 1M1 | |
| Centre Inflammatory Arthritis Disease Studies | |
| Winnipeg, Manitoba, Canada, R3N OK6 | |
| Canada, Ontario | |
| The Arthritis Program Research Group Inc. | |
| Newmarket, Ontario, Canada, L3Y 3R7 | |
| Ottawa General Hospital | |
| Ottawa, Ontario, Canada, K1H 8L6 | |
| Charlton Medical Center | |
| Hamilton, Ontario, Canada, L8N 1Y2 | |
| MAC Research, Inc. | |
| Hamilton, Ontario, Canada, L8N 2B6 | |
| K-W Musculoskeletal Research, Inc. | |
| Kitchener, Ontario, Canada, N2M 5N6 | |
| Canada, Quebec | |
| Rheumatic Disease Center of Montreal | |
| Montreal, Quebec, Canada, H3Z 2Z3 | |
| Canada, Saskatchewan | |
| Midtown Medical Center | |
| Saskatoon, Saskatchewan, Canada, S7K 0H6 | |
More Information
| Study ID Numbers: | MI-CP100 |
| Study First Received: | September 12, 2003 |
| Last Updated: | November 26, 2007 |
| ClinicalTrials.gov Identifier: | NCT00069017 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
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 |