NCT00034203CompletedPhase 2
Safety and Efficacy of a Monoclonal Antibody for Treatment of Rheumatoid Arthritis.
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- XOMA (US) LLC
- Locations
- 52
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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/mm
- •WBC count < 3,500 cells/mm
- •Seropositive for hepatitis B surface antigen.
- •Seropositive for hepatitis C antibody.
- •Known seropositivity for HIV.
Arms & Interventions
Untitled Study
Intervention: efalizumab (Drug)
Investigators
Study Sites (52)
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