Effects of MEDI-522 On Disease Activity and Progression of Joint Damage in Patients With Active Rheumatoid Arthritis Suboptimally Responding to Methotrexate
NCT ID: NCT00069017
Last Updated: 2007-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
300 participants
INTERVENTIONAL
2003-09-30
2006-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Study Groups
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1
MEDI-522 - 4 mg/kg of MEDI-522 (N=200)
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 (N=100)
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
8. Able and willing to complete assessment questionnaires.
9. Willing to participate in study through Study Day 413.
Exclusion Criteria
1. Severe active RA, which in the opinion of the investigator currently requires an alternative form of therapy
2. Acute illness at the start of the study
3. Evidence of significant active infection, such as fever greater than or equal to 38.0°C (100.5°F)
4. Known or suspected infection with human immunodeficiency virus (HIV) or other evidence of clinically significant immune deficiencies
5. Evidence of active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, such as positive HBsAg or positive anti-hepatitis C antibody
6. Insulin-dependent diabetes mellitus that is recent-onset or unstable
7. 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
8. 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
9. 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)
10. Current or any past therapy with anti-TNF biologic antagonists including etanercept, infliximab, and adalimumab
11. 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.
12. 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.
13. History of allergic disease or reactions likely to be exacerbated by any component of MEDI-522
14. History of gastrointestinal bleeding (i.e., stool positive for occult blood or overt bleeding) within the previous 6 months
15. Known bleeding disorder or significant risk of clinically important abnormal bleeding due to anticoagulant therapy with warfarin or heparin
16. Elective surgery planned during the study period through Study Day 413
17. Cardiovascular disease that is unstable, such as recent-onset angina, or angina with increasing frequency or severity, or recent myocardial infarction (within past 1 year without definitive corrective surgery such as coronary bypass graft or angioplasty)
18. Neurological disease, such as multiple sclerosis, previous stroke, clinically significant cerebrovascular disease, or other forms of organic brain disease that is clinically significant
19. Pulmonary, hepatic, renal, or hematological disease that is unstable and progressive, or clinically severe
20. Pregnancy (all females, unless surgically sterile or at least one year post-menopausal, must have a negative urine pregnancy test on Study Day 0, prior to dosing)
21. Nursing mother
22. History of alcohol or drug abuse within past 2 years
23. Evidence on physical examination of rheumatoid or other types of vasculitis.
18 Years
ALL
No
Sponsors
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MedImmune LLC
INDUSTRY
Locations
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The University of Alabama at Birmingham
Birmingham, Alabama, United States
Sun Valley Arthritis Center
Glendale, Arizona, United States
Arizona Research & Education
Phoenix, Arizona, United States
University of Arizona
Tucson, Arizona, United States
Fayetteville Diagnostic Clinic, Ltd.
Fayetteville, Arkansas, United States
Thornton Hospital
La Jolla, California, United States
Boling Clinical Trials
Rancho Cucamonga, California, United States
Pacific Arthritis Center Medical Group
Santa Maria, California, United States
Arthritis and Rheumatic Disease Specialty
Aventura, Florida, United States
Centre for Rheumatology, Immunology & Arthritis
Fort Lauderdale, Florida, United States
Ocala Rheumatology Research Center
Ocala, Florida, United States
Sarasota Arthritis Research Center
Sarasota, Florida, United States
Sanford S. Hartman
Decatur, Georgia, United States
Center for Rheumatology and Bone Research
Wheaton, Maryland, United States
RIMA
St Louis, Missouri, United States
Arthritis Consultants, Inc.
St Louis, Missouri, United States
Rheumatology Associates of New Jersey
Teaneck, New Jersey, United States
The Center for Rheumatology
Albany, New York, United States
Health Research Institute
Oklahoma City, Oklahoma, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Oklahoma Center for Arthritis Therapy and Research Inc.
Tulsa, Oklahoma, United States
Amarillo Center for Clinical Research
Amarillo, Texas, United States
Radiant Research
Dallas, Texas, United States
Arthritis & Osteoporosis Associates, LLP
Lubbock, Texas, United States
University of Utah Medical Hospital
Salt Lake City, Utah, United States
The Physician's Clinic of Spokane
Spokane, Washington, United States
Rheumatology Northwest/Clinical Trials Northwest
Yakima, Washington, United States
Gundersen Clinic Ltd.
La Crosse, Wisconsin, United States
University of Wisconsin Hospital & Clinics
Madison, Wisconsin, United States
Richmond Health Science Center
Richmond, British Columbia, Canada
Manitoba Clinic
Winnipeg, Manitoba, Canada
Arthritis Centre
Winnipeg, Manitoba, Canada
Centre Inflammatory Arthritis Disease Studies
Winnipeg, Manitoba, Canada
Charlton Medical Center
Hamilton, Ontario, Canada
MAC Research, Inc.
Hamilton, Ontario, Canada
K-W Musculoskeletal Research, Inc.
Kitchener, Ontario, Canada
The Arthritis Program Research Group Inc.
Newmarket, Ontario, Canada
Ottawa General Hospital
Ottawa, Ontario, Canada
Rheumatic Disease Center of Montreal
Montreal, Quebec, Canada
Midtown Medical Center
Saskatoon, Saskatchewan, Canada
Countries
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Other Identifiers
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MI-CP100
Identifier Type: -
Identifier Source: org_study_id