Effects of MEDI-522 On Disease Activity and Progression of Joint Damage in Patients With Active Rheumatoid Arthritis Suboptimally Responding to Methotrexate
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
1 other identifier
interventional
300
2 countries
40
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 rheumatoid-arthritis
Started Sep 2003
Typical duration for phase_2 rheumatoid-arthritis
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 12, 2003
CompletedFirst Posted
Study publicly available on registry
September 17, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2006
CompletedNovember 27, 2007
November 1, 2007
September 12, 2003
November 26, 2007
Conditions
Study Arms (2)
1
ACTIVE COMPARATORMEDI-522 - 4 mg/kg of MEDI-522 (N=200)
2
PLACEBO COMPARATORPlacebo (N=100)
Interventions
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.
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.
Eligibility Criteria
You may not qualify if:
- Patients must have none of the following:
- Severe active RA, which in the opinion of the investigator currently requires an alternative form of therapy
- Acute illness at the start of the study
- Evidence of significant active infection, such as fever greater than or equal to 38.0°C (100.5°F)
- Known or suspected infection with human immunodeficiency virus (HIV) or other evidence of clinically significant immune deficiencies
- Evidence of active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, such as positive HBsAg or positive anti-hepatitis C antibody
- Insulin-dependent diabetes mellitus that is recent-onset or unstable
- Evidence of active or latent tuberculosis, which may include a positive PPD skin test result (greater than or equal to 10 mm induration), unless appropriate INH prophylaxis for tuberculosis previously given; a chest X-ray possibly consistent with tuberculosis; or household contact with a patient with active tuberculosis
- A medical history or evidence of clinically important chronic infection, recurrent (3 or more) infections in the past 6 months requiring antibiotics, or an infection in the past month requiring systemic antibiotics
- Receipt of any investigational drug therapy, except MEDI-522, within 3 months prior to study randomization (use of licensed agents for indications not listed in the package insert is permitted)
- Current or any past therapy with anti-TNF biologic antagonists including etanercept, infliximab, and adalimumab
- Current therapy with cyclosporin A, leflunomide, cyclophosphamide, azathioprine, gold salts, d-penicillamine, mycophenylate mofetil, minocycline or anakinra. These drugs must have been discontinued at least 4 weeks prior to study randomization.
- Prednisone or equivalent at \>10 mg per day orally in the 8 weeks before study randomization. Intraarticular, periarticular, or other forms of parenteral injection of corticosteroids are also not permitted in the 8 weeks prior to study randomization.
- History of allergic disease or reactions likely to be exacerbated by any component of MEDI-522
- History of gastrointestinal bleeding (i.e., stool positive for occult blood or overt bleeding) within the previous 6 months
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MedImmune LLClead
Study Sites (40)
The University of Alabama at Birmingham
Birmingham, Alabama, 35249-7201, United States
Sun Valley Arthritis Center
Glendale, Arizona, 85308, United States
Arizona Research & Education
Phoenix, Arizona, 85012, United States
University of Arizona
Tucson, Arizona, 85724, United States
Fayetteville Diagnostic Clinic, Ltd.
Fayetteville, Arkansas, 72703, United States
Thornton Hospital
La Jolla, California, 92037-0943, United States
Boling Clinical Trials
Rancho Cucamonga, California, 91730, United States
Pacific Arthritis Center Medical Group
Santa Maria, California, 93454, United States
Arthritis and Rheumatic Disease Specialty
Aventura, Florida, 33180, United States
Centre for Rheumatology, Immunology & Arthritis
Fort Lauderdale, Florida, 33334, United States
Ocala Rheumatology Research Center
Ocala, Florida, 34474, United States
Sarasota Arthritis Research Center
Sarasota, Florida, 34239, United States
Sanford S. Hartman
Decatur, Georgia, 30033, United States
Center for Rheumatology and Bone Research
Wheaton, Maryland, 20902, United States
RIMA
St Louis, Missouri, 63131, United States
Arthritis Consultants, Inc.
St Louis, Missouri, 63141, United States
Rheumatology Associates of New Jersey
Teaneck, New Jersey, 07666, United States
The Center for Rheumatology
Albany, New York, 12206, United States
Health Research Institute
Oklahoma City, Oklahoma, 73109, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Oklahoma Center for Arthritis Therapy and Research Inc.
Tulsa, Oklahoma, 74114, United States
Amarillo Center for Clinical Research
Amarillo, Texas, 79124, United States
Radiant Research
Dallas, Texas, 75235, United States
Arthritis & Osteoporosis Associates, LLP
Lubbock, Texas, 79410, United States
University of Utah Medical Hospital
Salt Lake City, Utah, 84132, United States
The Physician's Clinic of Spokane
Spokane, Washington, 99204, United States
Rheumatology Northwest/Clinical Trials Northwest
Yakima, Washington, 98902, United States
Gundersen Clinic Ltd.
La Crosse, Wisconsin, 54601, United States
University of Wisconsin Hospital & Clinics
Madison, Wisconsin, 53792-3244, United States
Richmond Health Science Center
Richmond, British Columbia, V7C 5L9, Canada
Manitoba Clinic
Winnipeg, Manitoba, R3A 1M1, Canada
Arthritis Centre
Winnipeg, Manitoba, R3A 1M4, Canada
Centre Inflammatory Arthritis Disease Studies
Winnipeg, Manitoba, R3N OK6, Canada
Charlton Medical Center
Hamilton, Ontario, L8N 1Y2, Canada
MAC Research, Inc.
Hamilton, Ontario, L8N 2B6, Canada
K-W Musculoskeletal Research, Inc.
Kitchener, Ontario, N2M 5N6, Canada
The Arthritis Program Research Group Inc.
Newmarket, Ontario, L3Y 3R7, Canada
Ottawa General Hospital
Ottawa, Ontario, K1H 8L6, Canada
Rheumatic Disease Center of Montreal
Montreal, Quebec, H3Z 2Z3, Canada
Midtown Medical Center
Saskatoon, Saskatchewan, S7K 0H6, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 12, 2003
First Posted
September 17, 2003
Study Start
September 1, 2003
Study Completion
April 1, 2006
Last Updated
November 27, 2007
Record last verified: 2007-11