Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:37 PM
Ignite Modification Date:
2025-12-24 @ 7:37 PM
NCT ID:
NCT03917303
Eligibility Criteria:
Inclusion Criteria:
* Newly diagnosed CD patients or CD patients with a flare, visiting the outpatient clinic or endoscopy ward of the participating centres
* CD diagnosis according to ECCO-guidelines + complete ileo-colonoscopy + complete small bowel imaging at diagnosis (MRI or CT-enterography )
* Naïve to biologicals
* Sufficient knowledge of Dutch language
* 18 years old ≤ 70 years old
* Smartphone with internet access
* Use of myIBDcoach or willingness to start using myIBDcoach
Exclusion Criteria:
* Use of prednisone for longer than 4 weeks in the year before screening
* Use of budesonide (≥6 mg daily) for a duration longer than 3 months in the year before screening
* Use of thiopurines in the 3 years before screening
* Indication for primary treatment with biologicals or surgery
* Malignancy in 5 years before treatment. Exception is adequately treated non-melanoma skin cancer
* Contra-indication for TNF-blockers or immunosuppressive agents
* Contra-indication for MRI- and CT-enterography
* Patients with short bowel syndrome or an ostomy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03917303
Study Brief:
Protocol Section:
NCT03917303