Effects of MEDI-522 On Disease Activity and Progression of Joint Damage in Patients With Active Rheumatoid Arthritis Suboptimally Responding to Methotrexate

Completed · Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT00069017

Run by

MedImmune LLC

People needed

300

Starts

2003-09-01

Expected to finish

2006-04-01

Last updated by the study team

2007-11-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• Known bleeding disorder or significant risk of clinically important abnormal bleeding due to anticoagulant therapy with warfarin or heparin
• Elective surgery planned during the study period through Study Day 413
• 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)
• Neurological disease, such as multiple sclerosis, previous stroke, clinically significant cerebrovascular disease, or other forms of organic brain disease that is clinically significant
• Pulmonary, hepatic, renal, or hematological disease that is unstable and progressive, or clinically severe
• 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)
• Nursing mother
• History of alcohol or drug abuse within past 2 years
• Evidence on physical examination of rheumatoid or other types of vasculitis.

Where it is running

• 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

Full record on ClinicalTrials.gov

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