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 @ 10:23 PM
Ignite Modification Date:
2025-12-24 @ 10:23 PM
NCT ID:
NCT02822235
Eligibility Criteria:
Inclusion Criteria:
1. Male or female.
2. 18 years or older (at the time of diagnosis of moderate to severe UC or CD).
3. Diagnosis of moderate to severe CD or UC for at least 6 months prior to Day 1 appointment according the clinical or endoscopic \\ criteria.
4. Has provided the written informed consent. For the prospective period, eligible participants should present at least one of the following criteria that will only be applied at Day 1:
5. For CD participants:
* Harvey Bradshaw Index (HBI) ≥8 or
* Crohn's Disease Activity Index (CDAI) ≥220 or Considering that for CD participants, the disease activity may not be clearly documented only with clinical data, some objective criteria may be considered as entry criteria for the 12-month prospective period:
* Colonoscopy in the previous year suggestive of inadequate control of activity or,
* Calprotectin levels in the previous year suggestive of inadequate control of activity (i.e, calprotectin \>200 µg/g).
6. For UC: partial Mayo Score ≥5.
Note: Participants with colostomy and prospective period: Although clinical scales defined above are impacted by colostomy these participants will not be excluded from the protocol to ensure the assessment of different clinical presentations of the IBD. In addition, participants with colostomy must follow the same criteria as above to be eligible to the prospective phase.
Exclusion Criteria:
1. Indeterminate or not classified colitis.
2. Current or previous participation in interventional clinical trial (within the last 3 years). In addition, for the 12-month prospective period, participants will be excluded if:
3. Presenting mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
4. Hospitalized participants at Day 1.
5. Current off label treatment with Vedolizumab.
Study Discontinuation Criteria It will be considered a premature termination the situation in which the participant discontinues the participation, i.e. they are withdrawn from the study before completing the 12 months of follow up period (365 days ± 14 days from Day 1), due to any of the reasons listed below:
1. Withdrawal of consent: participants who for any reason withdraw the free and informed consent;
2. Lost to follow-up (no return of the participant on the expected date of visit - drop-out from the protocol);
3. Death;
4. Study termination;
5. Any situation that places the participant within one of the exclusion criteria.
Note: Participants who are eligible for the prospective period, it means, with active disease at Day 1 but who during the 12 months period presents disease remission and/or no activity disease condition, are allowed to continue the participation in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02822235
Study Brief:
Protocol Section:
NCT02822235