Recruiting studies for Crohn’s disease

The IBD trial unit currently has six 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@amc.uva.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.

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

Protocol: 2014-100757
IP: vedolizumab

Contact: ibdstudies@amc.uva.nl

Status: RECRUITING

An open label observational phase 4 study to Evaluate Efficacy, Safety and Mucosal Healing of early versus late use of vedolizumab in Crohn’s disease: the LOVE-CD study (LOw countries VEdolizumab in CD study)

Main inclusion criteria
Early Crohn’s disease
Diagnosis of CD < 24 months prior to enrollment
– Demonstrated failure to respond to topical or systemic corticosteroids or intolerance to corticosteroids or: need for 1 course of steroids since diagnosis or: steroid dependency at any dose since diagnosis.

Late Crohn’s disease
– Diagnosis of CD > 24 months prior to treatment
– Demonstrated failure to respond to at least 3 months of thiopurines or intolerance to thiopurines and: failure to respond to at least 1 anti-TNF or intolerance to anti-TNF or loss of response to at least 1 anti-TNF.

Main exclusion criteria
– Prior treatment with vedolizumab
– Presence of ostomy

STOC STUDY
Investigator:
Dr. M. Löwenberg

Protocol: STOC STUDY
IP: PCCE 2 capsule

Contact: ibdstudies@amc.uva.nl

Status: RECRUITING

A prospective study to assess the performance of the second generation pillcam colon capsule (PCCE 2) in Crohn’s Disease before and after treatment with anti-TNF agents. The objective is to examine sensitivity and specificity of the PCCE 2 (Pillcam) to detect mucosal healing in Crohn’s patients.

20 patients with active ileocolonic Crohn’s disease undergoing capsule endoscopy instead of  a colonoscopy before and 8-12 weeks after treatment initiation with Infliximab or Adalimumab.
Duration study: 1-14 weeks

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

StudyAcronym: SPICY -trial

Design: Multicenter Randomised Controlled Trial

Aim: 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

PISA-Trial
Investigator:
Prof. dr. G. D’Haens (PI)
Dr. C. Buskens (PI)
Prof. dr. W. Bemelman (PI)

Contact: k.a.wasmann@amc.nl

Status: RECRUITING

Study to evaluate three treatment strategies for complex perianal fistulas in Crohn’s disease: chronic seton drainage vs anti-TNF vs surgical closure (advancement plasty / LIFT).

If patients don’t want to be randomised, the preferred treatment can be assessed in the PISA registration study (patient preference model).

Follow-up of 1.5 year to assess the primary outcome reinterventions and secondary the efficacy, quality of life and cost-effectiveness. To eventually aim for consensus about the treatment strategy.