Remote Monitoring of Patients With an Inflammatory Bowel Disease Under no or Maintenance Therapy

Inclusion Criteria:

Participants eligible for inclusion in this Trial must meet all of the following criteria:

1. Patients with Crohn's disease, or ulcerative colitis, or IBD type unclassified
2. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
3. At least 18 years of age at the time of signing the Informed Consent Form (ICF)
4. Patients with access to Mynexuzhealth via smartphone or internet
5. Patients must fluently speak, write, read Dutch.
6. Patients under stable treatment with oral mesalamine, thiopurines, methotrexate, subcutaneous biologicals and/or oral small molecules or under no such therapies at all for at least two years
7. Patients having access to mynexuzhealth (plexus hospitals) or HiX (ZOL)
8. Patients willing to perform a home-based fecal calprotectin measurement every three months through CalproSmart or a similar application, or to go to their general practitioner or a hospital close by to perform a classical ELISA to measure fecal calprotectin every three months*
9. Patients willing to go to their general practitioner or a hospital close by to perform a blood test every year*
10. Patients willing to go to their general practitioner or a hospital close by to perform the required three-monthly blood tests in case of treatment with thiopurines or methotrexate (evaluation of liver tests and complete blood count)*

    * On the day of the classical outpatient clinic organized every two years, this can be performed at UZ Leuven All participants that are considered for Trial participation, per the above criteria will be documented via applicable log forms in Investigator Site File (including Screen Failures).

Exclusion Criteria:

Participants eligible for this Trial must not meet any of the following criteria:

1. Patients receiving an intravenous biological therapy or any form of corticosteroids (with the exception of inhaled or dermatological corticosteroids) in the last two years,
2. Patients with a change in concomitant IBD therapies in the last two years (except for rectal therapies),
3. Patients with IBD-related surgery in the past two years,
4. Patients in whom the IBD team estimates that a more frequent follow-up is required (e.g., due to previous non-compliance, need for additional support, comorbidities such as primary sclerosing cholangitis, cancer, …)
5. Participation in an interventional Trial with an investigational medicinal product (IMP) or device
6. Pregnant patients at screening should be excluded. If the participant becomes pregnant during the study, case-by-case will be evaluated. Study participation or stop should be a mutual decision after clear discussion between physician and patient.

Participants who meet one or more of the above exclusion criteria must not proceed to be enrolled/randomized in the Trial and will be identified via applicable log forms in Investigator Site File.