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Ulcerative Colitis - Vedolizumab- With/Without Prior Exposure to Anti-TNF(Tumor Necrosis Factor)Therapy

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03802214
Recruitment Status : Recruiting
First Posted : January 14, 2019
Last Update Posted : May 29, 2020
Sponsor:
Collaborators:
Takeda
University of Western Ontario, Canada
University of California, San Diego
Information provided by (Responsible Party):
Aida Habtezion, Stanford University

Brief Summary:
A case-control study to evaluate the immunoinflammatory effect of prior exposure to anti-TNF therapy in patients with ulcerative colitis starting vedolizumab therapy

Condition or disease Intervention/treatment
Ulcerative Colitis Drug: Vedolizumab

Detailed Description:
Inflammatory bowel disease (IBD)- ulcerative colitis (UC) and Crohn's disease (CD)- are chronic conditions of the gastrointestinal tract. Treatment generally consists of immunosuppression to modify the dysregulated immune responses. Vedolizumab, an inhibitor of α4β7, is a highly effective therapy for treating IBD, that minimized adverse effects through its gut selective inhibition of lymphocyte trafficking. However, the mechanism of action remains incompletely characterized especially in those previously treated to other biologics and why some patients are either vedolizumab non-responders or fail to respond over time. We would like to address the question whether anti-TNF non-responders as well as those that either do not respond or fail overtime to respond to vedolizumab identifies a specific population with difficult to treat disease that have alternate trafficking patterns and whether prior exposure to anti-TNF alters the mucosal immune responses, and/or trafficking patterns when compared to anti-TNF naive patients that may help explain impaired response to vedolizumab induction therapy.

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: A Case-control Study to Evaluate the Immunoinflammatory Effect of Prior Exposure to Anti-TNF Therapy in Patients With Ulcerative Colitis Starting Vedolizumab Therapy
Estimated Study Start Date : June 1, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Vedolizumab

Group/Cohort Intervention/treatment
vedolizumab-UC-naïve to TNF-antagonist
standard vedolizumab induction therapy for ulcerative colitis patients who are naïve to TNF-antagonist therapy
Drug: Vedolizumab
standard vedolizumab induction (300mg IV at week 0, 2, 6)
Other Name: Entyvio

vedolizumab-UC- previous TNF-antagonist
standard vedolizumab induction therapy for ulcerative colitis patients with previous TNF-antagonist exposure
Drug: Vedolizumab
standard vedolizumab induction (300mg IV at week 0, 2, 6)
Other Name: Entyvio




Primary Outcome Measures :
  1. Analysis of blood and tissue leukocytes (T cells, B cells and Dendritic cells) [ Time Frame: changes from enrollment to end of treatment (week 14) ]
    Analysis of blood and tissue leukocytes (T cells, B cells and Dendritic cells) in patients with and without prior anti-TNF exposure


Secondary Outcome Measures :
  1. Analysis of the serum and tissue concentrations of inflammatory markers (interleukins) [ Time Frame: changes from enrollment to end of treatment (week 14) ]
    Analysis of the serum and tissue concentrations of inflammatory markers (interleukins) in vedolizumab responders versus non-responders

  2. Analysis of the serum and tissue concentrations of vedolizumab [ Time Frame: changes from enrollment to end of treatment (week 14) ]
    Analysis of the serum and tissue concentrations of vedolizumab in patients with and without prior anti-TNF exposure


Biospecimen Retention:   Samples Without DNA
collection of blood and tissue specimens for immunology and drug assessment


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
clinical indication for biologic therapy, adult patients (>18) with the diagnosis of inflammatory bowel disease (Ulcerative Colitis) who are naive or failed anti-TNF therapy previously.
Criteria

Inclusion Criteria:

  • adult patients (>18 years old)
  • clinical diagnosis of inflammatory bowel disease (Ulcerative Colitis)
  • clinical indication for biologic therapy
  • naive or failed anti-TNF therapy previously

Exclusion Criteria:

  • patients allergic or intolerant to vedolizumab,
  • past use of vedolizumab;
  • patient unable to give consent to enter the study

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): NCT03802214


Contacts
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Contact: Aida Habtezion, MD 650-723-5488 aidah@stanford.edu
Contact: Reena Khanna, MD 519-685-8500 ext 34945 rkhanna3@uwo.ca

Locations
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United States, California
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: John Gubatan, MD    650-736-5555    jgubatan@stanford.edu   
Canada, Ontario
University of Western Ontario Active, not recruiting
London, Ontario, Canada, N6A5A5
Sponsors and Collaborators
Stanford University
Takeda
University of Western Ontario, Canada
University of California, San Diego
Investigators
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Principal Investigator: Aida Habtezion, MD Stanford University
Publications:

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Responsible Party: Aida Habtezion, Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT03802214    
Other Study ID Numbers: IRB48889
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We will share the data through the publication of results. Individual participant data was not promised to be shared.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Vedolizumab
Gastrointestinal Agents