Status:
TERMINATED
PsA Treatment With hOKT3γ1 (Ala-Ala)
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Immune Tolerance Network (ITN)
Conditions:
Arthritis, Psoriatic
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 psoriati...
Detailed Description
Psoriatic arthritis is a form of inflammatory arthritis that affects approximately 7% of people who have psoriasis. Treatment typically include drugs such as methotrexate, azathioprine, and etanercept...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 16 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 25 2008
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00239720
Start Date
March 16 2006
End Date
June 25 2008
Last Update
April 27 2017
Active Locations (2)
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1
University of Colorado
Aurora, Colorado, United States, 80010
2
University of Chicago
Chicago, Illinois, United States, 60637