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PsA Treatment With hOKT3γ1 (Ala-Ala) (PART)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00239720
Recruitment Status : Terminated (Study team decision-impact(s) of change in hOKT3γ1 (Ala-Ala) manufacturer during study.)
First Posted : October 17, 2005
Results First Posted : March 21, 2012
Last Update Posted : April 27, 2017
Sponsor:
Collaborator:
Immune Tolerance Network (ITN)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Description
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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.

Condition or disease Intervention/treatment Phase
Arthritis, Psoriatic Drug: hOKT3gamma1(Ala-Ala) Drug: Placebo Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Psoriatic Arthritis With hOKT3γ1 (Ala-Ala)
Actual Study Start Date : March 16, 2006
Actual Primary Completion Date : December 2006
Actual Study Completion Date : June 25, 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: hOKT3gamma1 (Ala-Ala)
Escalating dose of hOKT3gamma1 (Ala-Ala) given intravenously over 5 days of each 28 day cycle
 Drug: hOKT3gamma1(Ala-Ala)
Escalating dose given IV over 5 days (1mg, 2mg, 4mg on days 3-5) of each 28 day cycle
Other Name: anti-CD3 monoclonal antibody
Placebo Comparator: Placebo
Intravenous dose of placebo given over 5 days of each 28 day cycle
 Drug: Placebo
Intravenous dose of placebo given over 5 days of each 28 day cycle
Other Name: Placebo comparator


Outcome Measures
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Primary Outcome Measures :
  1. 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

    1. 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].
    2. Ref: Clegg DO et al. Arthritis Rheum. 1996; 39(12):2013-20.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00239720


Locations
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United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80010
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Immune Tolerance Network (ITN)
Investigators
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Principal Investigator: Marcus Clark, MD University of Chicago
More Information
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Additional Information:

Study Data/Documents: Study overview, - synopsis, -navigator, -schedule of events, -available biospecimen(s) et al.  This link exits the ClinicalTrials.gov site
Identifier: ITN011AI/NPA01 is Study ID
TrialShare is the ITN clinical research portal that provides public access to study data.

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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00239720    
Other Study ID Numbers: DAIT ITN011AI
First Posted: October 17, 2005    Key Record Dates
Results First Posted: March 21, 2012
Last Update Posted: April 27, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Psoriatic Arthritis
Arthritis
Psoriasis
Psoriatic
PsA
Additional relevant MeSH terms:
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Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
 Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Muromonab-CD3
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents