Study team decision-impact(s) of change in hOKT3γ1 (Ala-Ala) manufacturer during study.

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.

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.

Data access is provided in TrialShare, the Immune Tolerance Network (ITN) Clinical Trials Research Portal that makes data from the consortium's clinical trials publicly available.

Baseline to end of study (up to 24 months post baseline visit)

This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)

This study was put on voluntary clinical hold after a serious adverse event occurred. After a review of the data, the team decided to close the study to further enrollment. Due to limited participants, no formal statistical analyses were performed