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

NCT03802214 | Terminated FDA Drug

• 1 other identifier: IRB48889
• Study Type: observational
• Target: 1
• Locations: 2 countries
• Sites: 2

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

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• Analysis of blood and tissue leukocytes (T cells, B cells and Dendritic cells)

  Analysis of blood and tissue leukocytes (T cells, B cells and Dendritic cells) in patients with and without prior anti-TNF exposure

  changes from enrollment to end of treatment (week 14)

Secondary Outcomes (2)

• Analysis of the serum and tissue concentrations of inflammatory markers (interleukins)

  changes from enrollment to end of treatment (week 14)

• Analysis of the serum and tissue concentrations of vedolizumab

  changes from enrollment to end of treatment (week 14)

Study Arms (2)

vedolizumab-UC-naïve to TNF-antagonist

standard vedolizumab induction therapy for ulcerative colitis patients who are naïve to TNF-antagonist therapy

Drug: Vedolizumab

vedolizumab-UC- previous TNF-antagonist

standard vedolizumab induction therapy for ulcerative colitis patients with previous TNF-antagonist exposure

Drug: Vedolizumab

Interventions

Vedolizumab DRUG

standard vedolizumab induction (300mg IV at week 0, 2, 6)

Also known as: Entyvio

vedolizumab-UC- previous TNF-antagonist; vedolizumab-UC-naïve to TNF-antagonist

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead
• Takeda: collaborator
• University of Western Ontario, Canada: collaborator
• University of California, San Diego: collaborator

Study Sites (2)

Stanford University

Stanford, California, 94305, United States

Location

University of Western Ontario

London, Ontario, N6A5A5, Canada

Location

Related Publications (7)

• Schmitt H, Billmeier U, Dieterich W, Rath T, Sonnewald S, Reid S, Hirschmann S, Hildner K, Waldner MJ, Mudter J, Hartmann A, Grutzmann R, Neufert C, Munster T, Neurath MF, Atreya R. Expansion of IL-23 receptor bearing TNFR2+ T cells is associated with molecular resistance to anti-TNF therapy in Crohn's disease. Gut. 2019 May;68(5):814-828. doi: 10.1136/gutjnl-2017-315671. Epub 2018 May 30.

  PMID: 29848778 BACKGROUND

• Boden EK, Shows DM, Chiorean MV, Lord JD. Identification of Candidate Biomarkers Associated with Response to Vedolizumab in Inflammatory Bowel Disease. Dig Dis Sci. 2018 Sep;63(9):2419-2429. doi: 10.1007/s10620-018-4924-8. Epub 2018 Jan 25.

  PMID: 29372476 BACKGROUND

• Suzawa K, Kobayashi M, Sakai Y, Hoshino H, Watanabe M, Harada O, Ohtani H, Fukuda M, Nakayama J. Preferential induction of peripheral lymph node addressin on high endothelial venule-like vessels in the active phase of ulcerative colitis. Am J Gastroenterol. 2007 Jul;102(7):1499-509. doi: 10.1111/j.1572-0241.2007.01189.x. Epub 2007 Apr 24.

  PMID: 17459027 BACKGROUND

• Kobayashi M, Hoshino H, Masumoto J, Fukushima M, Suzawa K, Kageyama S, Suzuki M, Ohtani H, Fukuda M, Nakayama J. GlcNAc6ST-1-mediated decoration of MAdCAM-1 protein with L-selectin ligand carbohydrates directs disease activity of ulcerative colitis. Inflamm Bowel Dis. 2009 May;15(5):697-706. doi: 10.1002/ibd.20827.

  PMID: 19067429 BACKGROUND

• Sandborn WJ, Feagan BG, Rutgeerts P, Hanauer S, Colombel JF, Sands BE, Lukas M, Fedorak RN, Lee S, Bressler B, Fox I, Rosario M, Sankoh S, Xu J, Stephens K, Milch C, Parikh A; GEMINI 2 Study Group. Vedolizumab as induction and maintenance therapy for Crohn's disease. N Engl J Med. 2013 Aug 22;369(8):711-21. doi: 10.1056/NEJMoa1215739.

  PMID: 23964933 BACKGROUND

• Feagan BG, Rutgeerts P, Sands BE, Hanauer S, Colombel JF, Sandborn WJ, Van Assche G, Axler J, Kim HJ, Danese S, Fox I, Milch C, Sankoh S, Wyant T, Xu J, Parikh A; GEMINI 1 Study Group. Vedolizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2013 Aug 22;369(8):699-710. doi: 10.1056/NEJMoa1215734.

  PMID: 23964932 BACKGROUND

• Rosario M, Dirks NL, Gastonguay MR, Fasanmade AA, Wyant T, Parikh A, Sandborn WJ, Feagan BG, Reinisch W, Fox I. Population pharmacokinetics-pharmacodynamics of vedolizumab in patients with ulcerative colitis and Crohn's disease. Aliment Pharmacol Ther. 2015 Jul;42(2):188-202. doi: 10.1111/apt.13243. Epub 2015 May 20.

  PMID: 25996351 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

collection of blood and tissue specimens for immunology and drug assessment

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

vedolizumab

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Aida Habtezion, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 10, 2018
• First Posted: January 14, 2019
• Study Start: October 29, 2020
• Primary Completion: December 11, 2020
• Study Completion: December 11, 2020
• Last Updated: December 21, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); CA (1)