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

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.