Safety and Efficacy of a Monoclonal Antibody for Treatment of Rheumatoid Arthritis.

• Status: Completed
• Trial end date: 2003-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: XOMA (US) LLC

Criteria

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.