Assessment of 5-Aminosalicylic Acid Prescription Patterns and Treatment Outcomes in Patients With Ulcerative Colitis in Korea

Study Purpose

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. 5-Aminosalicylic acid (5-ASA), immunomodulator, or biologics, etc are prescribed to treat UC, however 5-ASA is generally considered the first-line therapy. The recent UC treatment guideline in Korea and the United States/ European Union (US/EU) have recommended higher daily dose for patients with mild or moderate severity than the previous guidelines since 2017. Accordingly, it is assumed that the average daily treatment dose of 5-ASA would increase in patients who were initially diagnosed with UC in real-world clinical practice in Korea. However, there are not many studies evaluating the treatment patterns and health outcomes of 5-ASA based on the recent treatment guideline in South Korea. This study, hence, aims to investigate the impact of changes in daily dose of 5-ASA on the treatment patterns and health outcomes such as recurrence rate, hospitalization rate, and surgery rate in real world practice using Health Insurance Review and Assessment (HIRA) claims database.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	15 Years and Over
Gender	All

More Inclusion & Exclusion 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).

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04499495
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Ferring Pharmaceuticals
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Global Clinical Compliance
Principal Investigator Affiliation	Ferring Pharmaceuticals
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Ulcerative Colitis