Arthritis, Psoriatic Clinical Trial
Official title:
Treatment of Psoriatic Arthritis With hOKT3gamma1 (Ala-Ala)
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.
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, which suppress the immune system in a nonspecific fashion in
an attempt to control the immune responses causing the disease. In some severe cases of
psoriatic arthritis, these drugs cannot adequately control the disease, often requiring
patients to undergo continuous treatment to prevent or combat disease activity. hOKT3gamma1
(Ala-Ala) is a genetically engineered monoclonal antibody directed against the CD3 antigen
on T cells. hOKT3gamma1 (Ala-Ala) specifically targets immune cells that are actively
involved in destructive immune responses, such as those that cause psoriatic arthritis. In a
small pilot study of eight people with psoriatic arthritis who received a 2-week course of
hOKT3gamma1 (Ala-Ala), the drug appeared safe and caused no serious side effects. This study
will test the safety and efficacy of hOKT3gamma1 (Ala-Ala) in alleviating symptoms in
psoriatic arthritis patients.
This study will last 2 years. Individuals with psoriatic arthritis who are receiving
methotrexate or azathioprine therapy and have active disease are eligible to participate.
Participants will be randomly assigned to receive hOKT3gamma1 (Ala-Ala) or placebo.
Participants will receive a 5-day treatment with the drug or placebo every month for the
first 4 months of the study. There will be 5 study visits over 2 years to assess the safety
and effectiveness of hOKT3gamma1 (Ala-Ala) and to evaluate laboratory measures related to
the underlying immune problems that cause psoriatic arthritis.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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