Recruiting studies for Crohn’s disease

The IBD clinical trial unit currently has several investigator initiated studies available for patients with Crohn’s disease.

The following studies are open for recruitment:

I-CARE
Investigator:
Dr. M. Löwenberg

Contact: ibdstudies@amsterdamumc.nl

Status: RECRUITING

This is a European prospective longitudinal observational multicenter cohort study.

The primary objective of I-CARE is to assess prospectively the presence and the extent of safety concerns (cancers (especially lymphoma) and serious infections risks) for anti-TNF alone or in combination with thiopurines among IBD patients.

Main inclusion criteria:
– Patient with an established diagnosis of Crohn’s disease, ulcerative colitis or IBD-unclassified, made at least 3 months earlier based on usual radiological, endoscopic or histological criteria.

Study duration 4 years; one year inclusion period and three-year follow-up period.
Number of patients needed: 17.000
Patient need to complete an e-Diary on a monthly basis and ePRO questionnaires once a year.

REPREVIO
Investigator:
Prof. dr. G.R.A.M. D’Haens

Protocol: 100752
IP: vedolizumab

Contact: ibdstudies@amsterdamumc.nl

Status: RECRUITING

This phase 4 multi-centre, randomized, placebo-controlled study will look into the effect of vedolizumab to prevent recurrence of CD after ileocolonic resection.

Patients will be consented to participate with 2-3 weeks following ileocolonic resection. The first study-infusion will also be given within 4 weeks if all inclusion and exclusion criteria are met.

Patients will receive intravenous infusions of 300 mg of VDZ or 250 ml or 0,9% sodium chloride only (placebo) at Week 0, Week 8, Week 16 and 24 in a 1:1 ratio.

This study will be 26 weeks in duration. Final dose of study drug will be administered at week 24.
All patients will undergo an ileocolonoscopy at week 26 following surgery.

The endpoint is the proportion of patients with clinically significant recurrence of CD after 6 months after surgery.

LOVE-CD
Investigator:
Prof. dr. G.R.A.M. D’Haens

Protocol: 2014-100757
IP: vedolizumab

Contact: ibdstudies@amsterdamumc.nl

Status: RECRUITING

An open label multi-centre observational phase 4 study to Evaluate Efficacy, Safety and Mucosal Healing of early versus late use of vedolizumab in Crohn’s disease.

2 cohorts:
– Patients with ‘early CD’
defined as disease duration < 24 months and no other treatments than corticosteroids and/or thiopurines
– Patients with ‘late CD’
defined as active disease despite treatment with immunosuppressives and anti-TNF.

Patients with intolerance to IS and anti-TNF will also be allowed in the latter group.

Participants will be treated with 12 months of open label vedolizumab and undergo monitoring of endoscopic, histological and clinical disease parameters.

SPICY Trial
Investigator:
Dr. C.J. Buskens (PI)
Prof. dr. W.A. Bemelman (PI)
E.M.L. van der Does de Willebois (Study Coordinator)

Contact: e.vanderdoesdewillebois@amsterdamumc.nl

Status: RECRUITING

This is a multi-center, randomised controlled trial to analyse the 6 month endoscopic recurrence following a mesenteric sparing versus a central mesenterectomy performing an ileocolic resection for Crohn’s disease

Patients will be randomised to mesenteric sparing ileocolic resection or to central mesenterectomy ileocolic resection.

The primary endpoint is endoscopic recurrence at six months as following ileocolic resection defined as Rutgeerts >i2b by central reading