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

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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 Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Arthritis, Psoriatic
Interventions Drug: hOKT3gamma1(Ala-Ala)
Drug: Placebo
Enrollment 4
Recruitment Details Two centers in the United States enrolled four participants between March 2006 and September 2006 who had psoriatic arthritis with three or more active joints despite ongoing therapy with methotrexate or azathioprine
Pre-assignment Details At screening visit, participants underwent procedures to establish inclusion/exclusion criteria and then sign the informed consent form
Arm/Group Title hOKT3gamma1 (Ala-Ala) Placebo
Hide Arm/Group Description Escalating dose of hOKT3gamma1 (Ala-Ala) given intravenously over 5 days of each 28 day cycle Intravenous dose of placebo given over 5 days of each 28 day cycle
Period Title: Overall Study
Started 3 1
Completed 2 [1] 0 [2]
Not Completed 1 1
Reason Not Completed
Adverse Event             1             0
Lost to Follow-up             0             1
[1]
One participant discontinued due to an adverse event
[2]
One participant lost to follow-up
Arm/Group Title hOKT3gamma1 (Ala-Ala) Placebo Total
Hide Arm/Group Description Escalating dose of hOKT3gamma1 (Ala-Ala) given intravenously over 5 days of each 28 day cycle Intravenous dose of placebo given over 5 days of each 28 day cycle Total of all reporting groups
Overall Number of Baseline Participants 3 1 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 1 participants 4 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
 100.0%
1
 100.0%
4
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 1 participants 4 participants
43.7  (9.6) 54  (0) 46.3  (9.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 1 participants 4 participants
Female
2
  66.7%
0
   0.0%
2
  50.0%
Male
1
  33.3%
1
 100.0%
2
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants 1 participants 4 participants
3 1 4
1.Primary Outcome
Title 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
Hide Description

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.
Time Frame 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat
Arm/Group Title hOKT3gamma1 (Ala-Ala) Placebo
Hide Arm/Group Description:
Escalating dose of hOKT3gamma1 (Ala-Ala) given intravenously over 5 days of each 28 day cycle
Intravenous dose of placebo given over 5 days of each 28 day cycle
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Baseline to end of study (up to 24 months post baseline visit)
Adverse Event Reporting Description 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)
 
Arm/Group Title hOKT3gamma1 (Ala-Ala) Placebo
Hide Arm/Group Description Escalating dose of hOKT3gamma1 (Ala-Ala) given intravenously over 5 days of each 28 day cycle Intravenous dose of placebo given over 5 days of each 28 day cycle
All-Cause Mortality
hOKT3gamma1 (Ala-Ala) Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
hOKT3gamma1 (Ala-Ala) Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/3 (33.33%)      0/1 (0.00%)    
Immune system disorders     
Cytokine release syndrome  1  1/3 (33.33%)  1 0/1 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 8.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
hOKT3gamma1 (Ala-Ala) Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/3 (66.67%)      1/1 (100.00%)    
Blood and lymphatic system disorders     
Leukopenia  1  1/3 (33.33%)  1 0/1 (0.00%)  0
Lymphopenia  1  2/3 (66.67%)  2 0/1 (0.00%)  0
Gastrointestinal disorders     
Dyspepsia  1  1/3 (33.33%)  1 0/1 (0.00%)  0
Nausea  1  2/3 (66.67%)  2 0/1 (0.00%)  0
General disorders     
Chills  1  2/3 (66.67%)  2 0/1 (0.00%)  0
Pyrexia  1  1/3 (33.33%)  1 0/1 (0.00%)  0
Infections and infestations     
Epstein-Barr virus infection  1  1/3 (33.33%)  1 0/1 (0.00%)  0
Hepatitis viral  1  1/3 (33.33%)  1 0/1 (0.00%)  0
Investigations     
CD4 lymphocytes decreased  1  1/3 (33.33%)  1 1/1 (100.00%)  1
Metabolism and nutrition disorders     
Hyperglycaemia  1  0/3 (0.00%)  0 1/1 (100.00%)  2
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/3 (33.33%)  1 0/1 (0.00%)  0
Back pain  1  1/3 (33.33%)  1 0/1 (0.00%)  0
Myalgia  1  2/3 (66.67%)  2 0/1 (0.00%)  0
Neck pain  1  1/3 (33.33%)  1 0/1 (0.00%)  0
Nervous system disorders     
Dizziness  1  1/3 (33.33%)  1 0/1 (0.00%)  0
Headache  1  2/3 (66.67%)  6 1/1 (100.00%)  1
Psychiatric disorders     
Insomnia  1  0/3 (0.00%)  0 1/1 (100.00%)  1
Renal and urinary disorders     
Dysuria  1  1/3 (33.33%)  1 0/1 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Nasal congestion  1  1/3 (33.33%)  1 0/1 (0.00%)  0
Skin and subcutaneous tissue disorders     
Hyperhidrosis  1  2/3 (66.67%)  2 0/1 (0.00%)  0
Rash papular  1  1/3 (33.33%)  1 0/1 (0.00%)  0
Vascular disorders     
Hypotension  1  1/3 (33.33%)  1 0/1 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 8.1
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
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Marcus Clark, MD
Organization: University of Chicago
Phone: 773-702-0202
EMail: mclark@medicine.bsd.uchicago.edu
Layout table for additonal information
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00239720     History of Changes
Other Study ID Numbers: DAIT ITN011AI
First Submitted: October 13, 2005
First Posted: October 17, 2005
Results First Submitted: February 15, 2012
Results First Posted: March 21, 2012
Last Update Posted: April 27, 2017