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Trial record 27 of 147 for:    visilizumab

Oral OKT3 for the Treatment of Active Ulcerative Colitis

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ClinicalTrials.gov Identifier: NCT01287195
Recruitment Status : Completed
First Posted : February 1, 2011
Results First Posted : June 14, 2017
Last Update Posted : February 11, 2019
Sponsor:
Information provided by (Responsible Party):
Scott B. Snapper, M.D., Ph.D., Brigham and Women's Hospital

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Ulcerative Colitis
Interventions Drug: Oral OKT3
Drug: Omeprazole
Enrollment 6
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Oral OKT3
Hide Arm/Group Description Participants with ulcerative colitis received 1 milligram (mg) Oral OKT3 given with 20 mg oral Omeprazole once daily for 30 days.
Period Title: Overall Study
Started 6
Completed 4
Not Completed 2
Reason Not Completed
Withdrawal by Subject             2
Arm/Group Title Oral OKT3
Hide Arm/Group Description Participants with ulcerative colitis received 1 mg Oral OKT3 given with 20 mg oral Omeprazole once daily for 30 days.
Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
All participants enrolled in the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants
39.5  (13.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
1
  16.7%
Male
5
  83.3%
1.Primary Outcome
Title Number of Participants With Adverse Events
Hide Description An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Time Frame From baseline to Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
All participants enrolled in the study.
Arm/Group Title Oral OKT3
Hide Arm/Group Description:
Participants with ulcerative colitis received 1 mg Oral OKT3 given with 20 mg oral Omeprazole once daily for 30 days.
Overall Number of Participants Analyzed 6
Measure Type: Count of Participants
Unit of Measure: Participants
3
  50.0%
2.Primary Outcome
Title Number of Participants With Anti-Drug Antibodies
Hide Description Serum samples were obtained to measure anti-drug antibodies during the study.
Time Frame From baseline to Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
All participants enrolled in the study.
Arm/Group Title Oral OKT3
Hide Arm/Group Description:
Participants with ulcerative colitis received 1 mg Oral OKT3 given with 20 mg oral Omeprazole once daily for 30 days.
Overall Number of Participants Analyzed 6
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
3.Primary Outcome
Title Percentage of Biomarker-positive Immune Cells
Hide Description Peripheral blood mononuclear cells were (PBMCs) were isolated from blood samples taken from each participant at baseline and Week 5. PBMCs were stained with a panel of fluorochrome-conjugated antibodies against multiple surface and intracellular biomarkers, including Cluster of Differentiation (CD) 3, CD4, CD8, Forkhead box P3 protein (FOXP3) and latency-associated peptide (LAP). The percentage of T cells positive for each of these biomarkers was determined by fluorescence activated cell sorting (FACS) and the mean percentage of positive T cells for each biomarker for all analyzed participants is reported.
Time Frame Baseline, Week 5
Hide Outcome Measure Data
Hide Analysis Population Description
All participants enrolled in the study for whom data were available at both time points.
Arm/Group Title Oral OKT3
Hide Arm/Group Description:
Participants with ulcerative colitis received 1 mg Oral OKT3 given with 20 mg oral Omeprazole once daily for 30 days.
Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: percentage of biomarker-positive T cells
CD3, Baseline Number Analyzed 6 participants
38  (19)
CD3, Week 5 Number Analyzed 4 participants
30  (22)
CD4, Baseline Number Analyzed 6 participants
59  (30)
CD4, Week 5 Number Analyzed 4 participants
75  (11)
CD8, Baseline Number Analyzed 6 participants
31  (16)
CD8, Week 5 Number Analyzed 4 participants
24  (11)
FOXP3, Baseline Number Analyzed 6 participants
5  (2.5)
FOXP3, Week 5 Number Analyzed 4 participants
4  (2)
LAP, Baseline Number Analyzed 6 participants
0.9  (0.5)
LAP, Week 5 Number Analyzed 4 participants
0.5  (0.4)
4.Primary Outcome
Title T Cell Proliferation of PBMCs in Cell Culture
Hide Description PBMCs isolated from whole blood obtained from participants at baseline, Weeks 1, 3, and 5 were assessed for proliferation in cell culture using a radioactive thymidine incorporation assay. A higher number indicates a higher level of proliferation.
Time Frame Baseline, Weeks 1, 3 and 5
Hide Outcome Measure Data
Hide Analysis Population Description
All participants enrolled in the study for whom data were available at each time point.
Arm/Group Title Oral OKT3
Hide Arm/Group Description:
Participants with ulcerative colitis received 1 mg Oral OKT3 given with 20 mg oral Omeprazole once daily for 30 days.
Overall Number of Participants Analyzed 6
Mean (Standard Error)
Unit of Measure: radioactive counts of cells per minute
Baseline 27470  (12340)
Week 1 49617  (17168)
Week 3 46575  (26762)
Week 5 20993  (15805)
5.Primary Outcome
Title Cytokine Production by PBMCs in Cell Culture
Hide Description Cytokine production was assessed in cell cultures of PBMCs obtained from participants at baseline, Weeks 1, 3 and 5. The following cytokines were detected and are reported here: interferon gamma (IFN-gamma), interleukin (IL)-17A, IL-6, IL-1 beta, tumor necrosis factor (TNF) and IL-10.
Time Frame Baseline, Weeks 1, 3 and 5
Hide Outcome Measure Data
Hide Analysis Population Description
All participants enrolled in the study for whom data were available at each time point.
Arm/Group Title Oral OKT3
Hide Arm/Group Description:
Participants with ulcerative colitis received 1 mg Oral OKT3 given with 20 mg oral Omeprazole once daily for 30 days.
Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: picograms/milliliter (pg/mL)
IFN gamma, Baseline Number Analyzed 6 participants
4935  (5520)
IFN gamma, Week 1 Number Analyzed 6 participants
11521  (6659)
IFN gamma, Week 3 Number Analyzed 4 participants
10178  (11671)
IFN gamma, Week 5 Number Analyzed 4 participants
2832  (2569)
IL-17A, Baseline Number Analyzed 6 participants
69  (93)
IL-17A, Week 1 Number Analyzed 6 participants
114  (117)
IL-17A, Week 3 Number Analyzed 5 participants
181  (368)
IL-17A, Week 5 Number Analyzed 4 participants
74  (95)
IL-6, Baseline Number Analyzed 6 participants
1470  (21010)
IL-6, Week 1 Number Analyzed 6 participants
2678  (3270)
IL-6, Week 3 Number Analyzed 4 participants
1978  (3491)
IL-6, Week 5 Number Analyzed 4 participants
567  (57980)
IL-1 beta, Baseline Number Analyzed 6 participants
110  (133)
IL-1 beta, Week 1 Number Analyzed 6 participants
155  (197)
IL-1 beta, Week 3 Number Analyzed 4 participants
185  (209)
IL-1 beta, Week 5 Number Analyzed 4 participants
38  (30)
TNF, Baseline Number Analyzed 6 participants
361  (282)
TNF, Week 1 Number Analyzed 6 participants
585  (324)
TNF, Week 3 Number Analyzed 3 participants
715  (724)
TNF, Week 5 Number Analyzed 4 participants
195  (157)
IL-10, Baseline Number Analyzed 6 participants
63  (79)
IL-10, Week 1 Number Analyzed 6 participants
115  (124)
IL-10, Week 3 Number Analyzed 4 participants
120  (97)
IL-10, Week 5 Number Analyzed 4 participants
15  (17)
6.Secondary Outcome
Title Mayo Score
Hide Description The Mayo Score is determined by the investigator by assigning a score to the following four assessments: stool frequency, rectal bleeding, physician’s global assessment and endoscopy. Total range for Mayo score is 0-12 with a higher score indicating a worse outcome.
Time Frame Baseline, Week 5
Hide Outcome Measure Data
Hide Analysis Population Description
All participants enrolled in the study for whom data were available at each time point.
Arm/Group Title Oral OKT3
Hide Arm/Group Description:
Participants with ulcerative colitis received 1 mg Oral OKT3 given with 20 mg oral Omeprazole once daily for 30 days.
Overall Number of Participants Analyzed 6
Mean (Standard Error)
Unit of Measure: score on a scale
Baseline Number Analyzed 6 participants
8.8  (1.6)
Week 5 Number Analyzed 4 participants
7.5  (1.7)
7.Secondary Outcome
Title Simple Clinical Colitis Activity Index (SCCAI) Score
Hide Description SCCAI is a symptom based questionnaire addressing five assessments, including bowel frequency day, bowel frequency night, urgency of defecation, blood in stool and general well-being. Score ranges from 0-15 with one additional point added for each manifestation of extracolonic features. A higher score indicates a worse outcome.
Time Frame Baseline, Week 5
Hide Outcome Measure Data
Hide Analysis Population Description
All participants enrolled in the study for whom data were available at each time point.
Arm/Group Title Oral OKT3
Hide Arm/Group Description:
Participants with ulcerative colitis received 1 mg Oral OKT3 given with 20 mg oral Omeprazole once daily for 30 days.
Overall Number of Participants Analyzed 6
Mean (Standard Error)
Unit of Measure: score on a scale
Baseline Number Analyzed 6 participants
7.7  (1.6)
Week 5 Number Analyzed 4 participants
6  (2.5)
8.Secondary Outcome
Title Score in Histologic Evaluation of Flexible Sigmoidoscopy
Hide Description Mucosal biopsies were obtained from the most inflamed area seen during flexible sigmoidoscopy and blindly scored by a single pathologist with scores ranging 0-3 with a higher score indicating a worse outcome.
Time Frame Baseline, Week 5
Hide Outcome Measure Data
Hide Analysis Population Description
All participants enrolled in the study for whom data were available at each time point.
Arm/Group Title Oral OKT3
Hide Arm/Group Description:
Participants with ulcerative colitis received 1 mg Oral OKT3 given with 20 mg oral Omeprazole once daily for 30 days.
Overall Number of Participants Analyzed 6
Mean (Standard Error)
Unit of Measure: score on a scale
Baseline Number Analyzed 6 participants
2.2  (0.7)
Week 5 Number Analyzed 4 participants
1.75  (0.9)
Time Frame From baseline up to Week 10
Adverse Event Reporting Description The safety population included all participants who received at least one dose of study medication.
 
Arm/Group Title Oral OKT3
Hide Arm/Group Description Participants with ulcerative colitis received 1 mg Oral OKT3 given with 20 mg oral Omeprazole once daily for 30 days.
All-Cause Mortality
Oral OKT3
Affected / at Risk (%)
Total   0/6 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Oral OKT3
Affected / at Risk (%)
Total   2/6 (33.33%) 
Gastrointestinal disorders   
Ulcerative colitis   1/6 (16.67%) 
Infections and infestations   
Anorectal abscess   1/6 (16.67%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Oral OKT3
Affected / at Risk (%)
Total   1/6 (16.67%) 
Eye disorders   
Periorbital edema   1/6 (16.67%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Scott B. Snapper, M.D., Ph.D.
Organization: Brigham and Women’s Hospital
Phone: 617-919-4973
EMail: ssnapper@partners.org
Publications:
Layout table for additonal information
Responsible Party: Scott B. Snapper, M.D., Ph.D., Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01287195     History of Changes
Other Study ID Numbers: 2009P001448
First Submitted: January 28, 2011
First Posted: February 1, 2011
Results First Submitted: April 11, 2017
Results First Posted: June 14, 2017
Last Update Posted: February 11, 2019