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

NCT ID: NCT02229344

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 368 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-07-01
• Study Completion Date: 2022-02-22

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Newly Diagnosed Moderate to Severe Ulcerative Colitis

Participants with newly diagnosed moderate to severe ulcerative colitis in a tertiary referral hospital within 4 weeks before prior to enrollment will be observed.

No Intervention

Intervention Type: OTHER

Participants with newly diagnosed moderate to severe ulcerative colitis in a tertiary referral hospital within 4 weeks before prior to enrollment will be observed.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Participant is newly diagnosed with moderate to severe ulcerative colitis in a tertiary referral hospital within 4 weeks prior to enrollment
• The diagnosis was based on symptoms consistent with ulcerative colitis lasting for more than 4 weeks, excluding infections and other acute or chronic non-infectious bowel syndrome conditions
• Participants meet diagnostic criteria for ulcerative colitisif at least 3 out of 4 of the following are met: 1) A History of diarrhea and/or blood/pus in stool, 2) Macroscopic appearance at endoscopy, with continuous mucosal inflammation affecting the rectum in continuity with some or all of the colon, 3) Microscopic features on biopsy consistent with ulcerative colitis, 4) No suspicion of Crohn's disease or indeterminate colitis
• Participants are willing to participate in regular follow-up visits
• Participant is willing to participate in the study and has signed the informed consent

Exclusion Criteria

• Participants in an interventional clinical trial with systemic corticosteroid, biologics (including, but not limited to, infliximab, golimumab, adalimumab and vedolizumab, etc) and other drugs (sulfasalazine, medalamine, azathioprine, tofacitinib, etc) for ulcerative colitis
• Having experienced colectomy such as subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Koch pouch, or ileostomy for ulcerative colitis, or planning surgical treatment within 1 year from enrollment
• A current diagnosis of indeterminate colitis, or current diagnosis or history of Crohn's disease

• Minimum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Korea, Ltd., Korea

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Korea, Ltd., Korea Clinical Trial

Role: STUDY_DIRECTOR

Janssen Korea, Ltd., Korea

Locations

Ansan-si, , South Korea

Busan, , South Korea

Cheonan, , South Korea

Cheongju-si, , South Korea

Daegu, , South Korea

Daejeon, , South Korea

Guri-si, , South Korea

Gwangju, , South Korea

Iksan, , South Korea

Incheon, , South Korea

Kwanju, , South Korea

Seongnam-si, , South Korea

Seoul, , South Korea

Suwon, , South Korea

Wŏnju, , South Korea

Countries

South Korea

Other Identifiers

REMICADECRD4016

Identifier Type: OTHER

Identifier Source: secondary_id

INF-KOR-5005

Identifier Type: OTHER

Identifier Source: secondary_id

CR103116

Identifier Type: -

Identifier Source: org_study_id