hOKT3gamma1 (Ala-Ala) for the Treatment of Psoriatic Arthritis

Arthritis, Psoriatic Clinical Trial

— PART  

Official title:

Treatment of Psoriatic Arthritis With hOKT3gamma1 (Ala-Ala)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00239720
• Other study ID #: DAIT ITN011AI
• Status: Terminated
• Phase: Phase 2
• First received: October 13, 2005
• Last updated: February 15, 2012
• Start date: March 2006
• Est. completion date: June 2008

Study information

• Verified date: February 2012
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: June 2008
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

• 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

• Pregnant or breastfeeding

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic

Intervention

Drug:
• hOKT3gamma1(Ala-Ala)
Escalating dose given IV over 5 days (1mg, 2mg, 4mg on days 3-5) of each 28 day cycle
• Placebo
i.v. given over 5 days of each 28 day cycle

Locations

Country	Name	City	State
United States	University of Colorado	Aurora	Colorado
United States	University of Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Immune Tolerance Network (ITN)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Participants Who Received at Least Two Cycles of Treatment and Who Showed Predefined Levels of Improvement in Primary Efficacy Parameter at Six Months	Participants who improve by at least 1 unit from baseline in either the physician or participant global assessment and have at least 30% improvement from baseline in either tender or swollen joint scores[1] at 6 months from start of treatment and received at least 2 cycles of treatment; The tender and swollen joint scores assess 68 and 66 joints, respectively, with each joint rated from 0 to 3. Total scores range from 0-204 for tenderness and 0-198 for swelling, with higher scores indicating more severe symptoms[2].; Ref: Clegg DO et al. Arthritis Rheum. 1996; 39(12):2013-20.	6 Months	No

External Links

•   Click here for the Immune Tolerance Network Web site
•   Click here for the Psoriatic Arthritis Research and Treatment Study Web site