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 @ 2:16 PM
Ignite Modification Date:
2025-12-24 @ 2:16 PM
NCT ID:
NCT04499495
Eligibility Criteria:
Inclusion Criteria:
* Patients who were diagnosed with UC during the index period.
* Patients who had at least two claims of 5-ASA (sulfasalazine, balsalazide, mesalamine) during the index period.
* Patients who underwent at least one endoscopy within a 3-month period prior to the index date (i.e. the first date of diagnosis with UC).
* Defined as a claim with relevant endoscopy procedure code.
* Include the upper gastrointestinal endoscopy, colonoscopy, sigmoidoscopy, which are identified using the procedure code.
* Patients who were treated with 5-ASA continuously for at least 1-month after the index date.
* Defined as those who were treated with 5-ASA for more than 30 days within 6-month after the index date (i.e. the first date of diagnosis with UC).
Exclusion Criteria:
* Patients less than 15 years old as of the index date (\<15 years old).
* Patients who were treated with 5-ASA during the baseline period (i.e. 12-month prior to the index date).
* Patients who were diagnosed with UC during the baseline period.
* Patients who received steroids, immunosuppressants, or biologics during the baseline period.
* Steroid includes both oral medication and intravenous (IV) injection. The analysis will include the moderate- to high-dose of cumulative steroid use, which is defined as \>=30mg of prednisolone, \>= 50mg of methylprednisolone, or \>=50mg of hydrocortisone.
* Immunosuppressants is defined as at least one claim with Azathioprine or 6-Mercaptopurine.
* Biologics is defined as at least one claim with Infliximab, Adalimumab, Ustekinumab, Vedolizumab, Golimumab, or Tofacitinib.
* Patients who were diagnosed with Crohn's disease at any time in the overall study period.
* Defined as a claim with relevant Crohn's disease code recorded as primary diagnosis during the baseline period or follow-up period (i.e. entire study period).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Study:
NCT04499495
Study Brief:
Protocol Section:
NCT04499495