Status:
COMPLETED
Assessment of 5-Aminosalicylic Acid Prescription Patterns and Treatment Outcomes in Patients With Ulcerative Colitis in Korea
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
15+ years
Brief Summary
The prevalence of ulcerative colitis (UC), which is one of the inflammatory bowel diseases, is known to be increasing and the majority of patients (≥ 85%) have experienced mild or moderate severity. ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
October 25 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 31 2022
Estimated Enrollment :
11385 Patients enrolled
Trial Details
Trial ID
NCT04499495
Start Date
October 25 2021
End Date
July 31 2022
Last Update
September 10 2022
Active Locations (1)
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1
Severance Hospital
Seoul, Seodaemun-gu, South Korea