PsA Treatment With hOKT3γ1 (Ala-Ala)

NCT ID: NCT00239720

Last Updated: 2017-04-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-16
• Study Completion Date: 2008-06-25

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 psoriatic arthritis patients who are unable to control their arthritis with methotrexate or azathioprine.

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, 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.

Conditions

Arthritis, Psoriatic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

hOKT3gamma1 (Ala-Ala)

Escalating dose of hOKT3gamma1 (Ala-Ala) given intravenously over 5 days of each 28 day cycle

Group Type: EXPERIMENTAL

hOKT3gamma1(Ala-Ala)

Intervention Type: DRUG

Escalating dose given IV over 5 days (1mg, 2mg, 4mg on days 3-5) of each 28 day cycle

Placebo

Intravenous dose of placebo given over 5 days of each 28 day cycle

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Intravenous dose of placebo given over 5 days of each 28 day cycle

Interventions

hOKT3gamma1(Ala-Ala)

Escalating dose given IV over 5 days (1mg, 2mg, 4mg on days 3-5) of each 28 day cycle

Intervention Type: DRUG

Placebo

Intravenous dose of placebo given over 5 days of each 28 day cycle

Intervention Type: DRUG

Other Intervention Names

anti-CD3 monoclonal antibody; Placebo comparator

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Immune Tolerance Network (ITN)

NETWORK

Sponsor Role: collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marcus Clark, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

University of Colorado

Aurora, Colorado, United States

University of Chicago

Chicago, Illinois, United States

Countries

United States

Study Documents

Document Type: Study overview, - synopsis, -navigator, -schedule of events, -available biospecimen(s) et al.

TrialShare is the ITN clinical research portal that provides public access to study data.

View Document

Related Links

https://www.niaid.nih.gov/

National Institute of Allergy and Infectious Diseases (NIAID) website

http://www.immunetolerance.org

Immune Tolerance Network (ITN) website

Other Identifiers

DAIT ITN011AI

Identifier Type: -

Identifier Source: org_study_id