NCT02229344

Study of Clinical Course of Newly Diagnosed Moderate to Severe Ulcerative Colitis in Korea

Cohort Study of Newly Diagnosed Moderate to Severe Ulcerative Colitis in Tertiary Referral Hospital Setting in Korea

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 368 (actual)
• Sponsor: Janssen Korea, Ltd., Korea · Industry
• Sex: All
• Age: 7 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to describe clinical course of newly diagnosed moderate to severe ulcerative colitis (chronic inflammatory disease of the colon) in tertiary referral hospitals in Korea for 5-year follow-up under usual care.

Detailed description

This is a multicenter (when medical research study takes place in more than one country), prospective (study following participants forward in time), disease-oriented and hospital-based 5-year follow-up longitudinal study in Korean participants with newly diagnosed moderate to severe ulcerative colitis who visit tertiary referral hospital. As the study is observational in nature, no intervention will be received by participants. Efficacy will primarily be assessed by number of relapses and percentage of participants achieving sustained remission (clinical, endoscopic and combined remission).

Conditions

• Colitis, Ulcerative

Interventions

Type	Name	Description
OTHER	No Intervention	Participants with newly diagnosed moderate to severe ulcerative colitis in a tertiary referral hospital within 4 weeks before prior to enrollment will be observed.

Timeline

• Start date: 2014-07-01
• Primary completion: 2022-02-22
• Completion: 2022-02-22
• First posted: 2014-09-01
• Last updated: 2025-04-27

Locations

15 sites across 1 country: South Korea