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Observationele studie naar de rol van α4β7 en andere afweercellen in pouchitis


- candidate number27330
- NTR NumberNTR6478
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-mei-2017
- Secondary IDsNL60196.018.16  AMC
- Public TitleObservationele studie naar de rol van α4β7 en andere afweercellen in pouchitis
- Scientific TitleLymphocyte trafficking and the effect of vedolizumab in pouchitis
- ACRONYMn/a
- hypothesisLymhocyte homing plays a role in the pathofysiology of pouchitis and vedolizumab could be a therapeutic target.
- Healt Condition(s) or Problem(s) studiedPouchitis, Pouch, IPAA
- Inclusion criteriaGroup 1:
- The subject has a history of ileal pouch anal anastomosis (IPAA) for Ulcerative Colitis completed at least 3 months prior to screening.
- The patient is scheduled for a surveillance or diagnostic endoscopy of the pouch.
- Age from 18 years, either male or female.
- Ability to give informed consent.


Group 2 and 3:
- The subject has a history of ileal pouch anal anastomosis (IPAA) for Ulcerative Colitis completed at least 3 months prior to screening.
- Age from 18 years, either male or female.
- Ability to give informed consent.
- The subject has chronic or recurrent pouchitis and may have antibiotic-dependent or antibiotic-refractory chronic pouchitis.
- Exclusion criteriaGroup 1:
- The subject has an IPAA that is less than 3 months old.
- The subject has a history of a perforation of the intestine after endoscopy or surgery.
- The subject currently has acute or chronic pouchitis, or had pouchitis in the past 3 months.
- The subject had prior exposure to vedolizumab, natalizumab, rituximab, etrolizumab or anti-MAdCAM-1 therapy in the past 6 months.
- Inability to give informed consent.
- The patient has Crohnís disease.


Group 2 and 3:
- The subject has an IPAA that is less than 3 months old.
- The subject currently uses or has prior exposure to vedolizumab, natalizumab, rituximab, etrolizumab or anti-MAdCAM-1 therapy in the past 6 months.
- The subject has a history of a perforation of the intestine after endoscopy or surgery.
- Inability to give informed consent.
- The patient has Crohnís disease.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 22-mrt-2017
- planned closingdate31-jan-2019
- Target number of participants30
- InterventionsGroup 1 and 2:
Day of endoscopy (scheduled in regular care):
- PDAI questionnaire
- Fecal sample
- 9ml Heparin tube
During endoscopy:
- 6 biopsies


Group 3:
Day of endoscopy (scheduled for EARNEST trial):
- PDAI questionnaire
- Fecal sample
- 9ml Heparin tube
During endoscopy:
- 6 biopsies


Additional endoscopy after 1 year (scheduled for EARNEST trial):
Day of endoscopy:
- PDAI questionnaire
- 5ml serum tube
- 9ml Heparin tube
During endoscopy:
- 6 biopsies
- Primary outcomeSemi-quantitative analysis of α4β7+ T-lymphocytes in ileal pouch biopsies of chronic pouchitis patients and changes thereof after resolution of endoscopic inflammation.
- Secondary outcome1. Semi-quantitative analysis of key-players of lymphocyte trafficking in pouchitis (e.g. MAdCAM-1, CCR9, CCR10, CCL25, CCL28, αEβ7)
2. Changes of lymphocyte subsets after treatment with vedolizumab
3. Vedolizumab serum levels in peripheral blood of patients treated with vedolizumab

- TimepointsGroup 1 and 2: 1 endoscopy
Group 3: 2 subsequent endoscopies, 1 year in between
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD. PhD. Cyriel Y. Ponsioen
- CONTACT for SCIENTIFIC QUERIESMD. PhD. Cyriel Y. Ponsioen
- Sponsor/Initiator Academic Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Takeda
- Publications
- Brief summaryBecause of medically refractory disease or colorectal neoplasia development, about 15% of ulcerative colitis (UC) patients will need a proctocolectomy with ileal-anal pouch reconstruction (IPAA). A common complication of IPAA is pouchitis, a nonspecific inflammation of the pouch, which occurs in about 50% of UC patients with IPAA. The pathogenesis of pouchitis is not well understood, but the innate and adaptive immune responses, microbiota-host interactions or defects in intestinal epithelial cells may play a role in this. Vedolizumab, a humanized monoclonal antibody that specifically binds to the lymphocyte integrin α4β7 may be beneficial for the treatment of pouchitis. However, blocking the interaction between MAdCAM-1 and α4β7 integrin on memory T and B cells by vedolizumab, which has been shown to be beneficial in IBD, hasnít been studied in pouchitis yet. With this observational study, we will look into different key players of lymphocyte trafficking in pouch biopsies of patients with and without pouchitis. We will also look at changes after treatment with vedolizumab.
- Main changes (audit trail)
- RECORD29-mei-2017 - 25-jul-2017


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