PsA Treatment With hOKT3γ1 (Ala-Ala)

• Status: Terminated
• Trial end date: 2008-06-25
• Target enrollment: 0
• Participant gender: All

Summary

hOKT3gamma1 (Ala-Ala) is a man-made antibody that is commonly used to prevent organ rejection. The purpose of this study is to determine whether hOKT3gamma1 (Ala-Ala) is safe and effective in psoriatic arthritis patients who are unable to control their arthritis with methotrexate or azathioprine.

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

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Immune Tolerance Network (ITN)
• Treatments: Muromonab-CD3

Criteria

Inclusion Criteria:

• Diagnosis of psoriatic arthritis. Participants do not need to have concurrent psoriasis to participate in the study;

• Active inflammation in 3 or more joints;

• Currently receiving ongoing therapy with methotrexate or azathioprine; and

• Willing to use acceptable forms of contraception.

Exclusion Criteria:

• Active infection with HIV, hepatitis C virus, or hepatitis B virus;

• Uncompensated heart failure or a recent myocardial infarction (heart attack) within the 6 months prior to study entry;

• Certain other serious illnesses or cancers;

• Participation in another clinical trial within the 6 weeks prior to study entry; or

• Pregnant or breastfeeding.