Rheumatoid Arthritis
Conditions
Brief summary
The purpose of this study is to determine whether a humanized monoclonal antibody (efalizumab) is safe and effective in the treatment of rheumatoid arthritis.
Interventions
DRUGefalizumab
Sponsors
XOMA (US) LLC
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of moderate to severe rheumatoid arthritis. * On stable dose of methotrexate. * 18 to 80 years of age. * Less than 275 lbs.
Exclusion criteria
* Joint replacement surgery within 60 days of the start of drug dosing. * Intra-articular cortisone injections within 28 days of the start of drug dosing. * Pregnancy. * History of severe allergic or anaphylactic reactions. * Active bacterial, viral, fungal, mycobacterium tuberculosis. * Positive PPD test. * History of any opportunistic infection. * Serious persisting local or systemic infection. * History of malignancy within the past five years. * Received any vaccine within 28 days of the start of study drug dosing. * Joint replacement therapy planned within nine months of the start of study drug dosing. * Chronic disorders apart from RA affecting the joints. * Significant systemic involvement secondary to RA. * COPD, asthma, or other pulmonary disease. * Received any DMARD other than methotrexate in the 28 days prior to the start of study drug dosing. * Approved biologic RA therapy during the 28 days or 7 half-lives of the drug prior to the start of drug dosing. * Investigational drug and/or treatment during the 28 days or seven half-lives of the investigational drug prior to the start of study drug dosing. * Liver disease or abnormal hepatic function. * Serum creatinine level \> 1.5 mg/dL. * Platelet count \< 125,000 cells/mm3. * WBC count \< 3,500 cells/mm3. * Seropositive for hepatitis B surface antigen. * Seropositive for hepatitis C antibody. * Known seropositivity for HIV.
Countries
United States
Outcome results
None listed