- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00239720
PsA Treatment With hOKT3γ1 (Ala-Ala) (PART)
Treatment of Psoriatic Arthritis With hOKT3γ1 (Ala-Ala)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Colorado
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Aurora, Colorado, United States, 80010
- University of Colorado
-
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Illinois
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Chicago, Illinois, United States, 60637
- University of Chicago
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: hOKT3gamma1 (Ala-Ala)
Escalating dose of hOKT3gamma1 (Ala-Ala) given intravenously over 5 days of each 28 day cycle
|
Escalating dose given IV over 5 days (1mg, 2mg, 4mg on days 3-5) of each 28 day cycle
Other Names:
|
Placebo Comparator: Placebo
Intravenous dose of placebo given over 5 days of each 28 day cycle
|
Intravenous dose of placebo given over 5 days of each 28 day cycle
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: 6 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
|
6 Months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Marcus Clark, MD, University of Chicago
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DAIT ITN011AI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Study Data/Documents
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Study overview, - synopsis, -navigator, -schedule of events, -available biospecimen(s) et al.
Information identifier: ITN011AI/NPA01 is Study IDInformation comments: TrialShare is the ITN clinical research portal that provides public access to study data.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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