Effects of MEDI-522 On Disease Activity and Progression of Joint Damage in Patients With Active Rheumatoid Arthritis Suboptimally Responding to Methotrexate
- Conditions
- Rheumatoid Arthritis
- Interventions
- Biological: MEDI-522Other: Placebo
- Registration Number
- NCT00069017
- Lead Sponsor
- MedImmune LLC
- 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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 MEDI-522 MEDI-522 - 4 mg/kg of MEDI-522 (N=200) 2 Placebo Placebo (N=100)
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (40)
RIMA
๐บ๐ธSt. Louis, Missouri, United States
Midtown Medical Center
๐จ๐ฆSaskatoon, Saskatchewan, Canada
Thornton Hospital
๐บ๐ธLa Jolla, California, United States
Sun Valley Arthritis Center
๐บ๐ธGlendale, Arizona, United States
Boling Clinical Trials
๐บ๐ธRancho Cucamonga, California, United States
Richmond Health Science Center
๐จ๐ฆRichmond, British Columbia, Canada
Arthritis Consultants, Inc.
๐บ๐ธSt. Louis, Missouri, United States
University of Arizona
๐บ๐ธTucson, Arizona, United States
Fayetteville Diagnostic Clinic, Ltd.
๐บ๐ธFayetteville, Arkansas, United States
Arthritis & Osteoporosis Associates, LLP
๐บ๐ธLubbock, Texas, United States
Gundersen Clinic Ltd.
๐บ๐ธLa Crosse, Wisconsin, United States
Manitoba Clinic
๐จ๐ฆWinnipeg, Manitoba, Canada
Arthritis Centre
๐จ๐ฆWinnipeg, Manitoba, Canada
Ottawa General Hospital
๐จ๐ฆOttawa, Ontario, Canada
Charlton Medical Center
๐จ๐ฆHamilton, Ontario, Canada
MAC Research, Inc.
๐จ๐ฆHamilton, Ontario, Canada
Centre Inflammatory Arthritis Disease Studies
๐จ๐ฆWinnipeg, Manitoba, Canada
The University of Alabama at Birmingham
๐บ๐ธBirmingham, Alabama, United States
Arizona Research & Education
๐บ๐ธPhoenix, Arizona, United States
Health Research Institute
๐บ๐ธOklahoma City, Oklahoma, United States
University of Utah Medical Hospital
๐บ๐ธSalt Lake City, Utah, United States
The Physician's Clinic of Spokane
๐บ๐ธSpokane, Washington, United States
Centre for Rheumatology, Immunology & Arthritis
๐บ๐ธFort Lauderdale, Florida, United States
Ocala Rheumatology Research Center
๐บ๐ธOcala, Florida, United States
Pacific Arthritis Center Medical Group
๐บ๐ธSanta Maria, California, United States
Arthritis and Rheumatic Disease Specialty
๐บ๐ธAventura, Florida, United States
Sarasota Arthritis Research Center
๐บ๐ธSarasota, Florida, United States
Sanford S. Hartman
๐บ๐ธDecatur, Georgia, United States
Center for Rheumatology and Bone Research
๐บ๐ธWheaton, Maryland, United States
Rheumatology Associates of New Jersey
๐บ๐ธTeaneck, New Jersey, United States
The Center for Rheumatology
๐บ๐ธAlbany, New York, United States
Amarillo Center for Clinical Research
๐บ๐ธAmarillo, Texas, United States
Rheumatology Northwest/Clinical Trials Northwest
๐บ๐ธYakima, Washington, United States
Lynn Health Science Institute
๐บ๐ธOklahoma City, Oklahoma, United States
University of Wisconsin Hospital & Clinics
๐บ๐ธMadison, Wisconsin, United States
K-W Musculoskeletal Research, Inc.
๐จ๐ฆKitchener, Ontario, Canada
Rheumatic Disease Center of Montreal
๐จ๐ฆMontreal, Quebec, Canada
The Arthritis Program Research Group Inc.
๐จ๐ฆNewmarket, Ontario, Canada
Oklahoma Center for Arthritis Therapy and Research Inc.
๐บ๐ธTulsa, Oklahoma, United States
Radiant Research
๐บ๐ธDallas, Texas, United States