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

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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

Tracking Information
First Submitted Date December 10, 2018
First Posted Date January 14, 2019
Last Update Posted Date May 29, 2020
Estimated Study Start Date June 1, 2020
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 9, 2019)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 9, 2019)
  • 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
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Ulcerative Colitis - Vedolizumab- With/Without Prior Exposure to Anti-TNF(Tumor Necrosis Factor)Therapy
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
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
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.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
collection of blood and tissue specimens for immunology and drug assessment
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.
Condition Ulcerative Colitis
Intervention Drug: Vedolizumab
standard vedolizumab induction (300mg IV at week 0, 2, 6)
Other Name: Entyvio
Study Groups/Cohorts
  • vedolizumab-UC-naïve to TNF-antagonist
    standard vedolizumab induction therapy for ulcerative colitis patients who are naïve to TNF-antagonist therapy
    Intervention: Drug: Vedolizumab
  • vedolizumab-UC- previous TNF-antagonist
    standard vedolizumab induction therapy for ulcerative colitis patients with previous TNF-antagonist exposure
    Intervention: Drug: Vedolizumab
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 9, 2019)
20
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Aida Habtezion, MD 650-723-5488 aidah@stanford.edu
Contact: Reena Khanna, MD 519-685-8500 ext 34945 rkhanna3@uwo.ca
Listed Location Countries Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03802214
Other Study ID Numbers IRB48889
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
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.
Responsible Party Aida Habtezion, Stanford University
Study Sponsor Stanford University
Collaborators
  • Takeda
  • University of Western Ontario, Canada
  • University of California, San Diego
Investigators
Principal Investigator: Aida Habtezion, MD Stanford University
PRS Account Stanford University
Verification Date May 2020