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:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT02634060
Eligibility Criteria:
Inclusion Criteria:
* At least 18 years of age;
* Established diagnosis of UC or CD for at least 3 months, with histopathological confirmation available in the record of the patient;
* Patients having failed steroids or immunomodulatory therapy for at least 3 months, or being intolerant to this therapy;
* Patients should have moderate-to-severe disease at baseline, defined as For CD: an Harvey-Bradshaw-Index above 7 and a C-reactive protein of at least 5 mg/L; For UC: a total Mayo score of at least 6 and an endoscopic sub-score of at least 2;
* Latent tuberculosis excluded within 3 months prior to ADA therapy using Chest X-ray and IFNγ release assay or tuberculin skin test; or adequate treatment for latent tuberculosis initiated for at least four weeks in case of positive screening;
* The patients should have a smartphone and be able to use a new smartphone application;
* Written informed consent must be obtained and documented;
Exclusion Criteria:
* Diagnosis of IBD type unclassified (IBDU);
* Previous (procto)colectomy for UC;
* Patients with an ostomy;
* Previous therapy with ADA;
* Patients with CD with a baseline CRP \< 5mg/L at baseline;
* Patients with CD and absence of luminal disease;
* Patient with UC lacking faecal blood loss (Mayo bleeding score 0);
* Patients with UC with an ileal pouch-anal or ileo-rectal anastomosis
* Patients with acute severe IV steroid refractory colitis;
* Patients with any condition that would prevent completion of the study including history of drug or alcohol abuse, history of mental illness, or history of noncompliance with treatments or visits;
* Patients with absolute or relative contraindications for anti-TNF therapy, including intra-abdominal collections, symptomatic strictures, demyelinating disease, heart failure, …;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02634060
Study Brief:
Protocol Section:
NCT02634060