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

NCT02229344 | Completed

• 3 other identifiers: CR103116REMICADECRD4016INF-KOR-5005
• Study Type: observational
• Target: 368
• Locations: 1 country
• Sites: 15

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.

Conditions

Colitis, Ulcerative

Keywords

colitis, ulcerative; MOSAIK; REMICADE; Infliximab

Outcome Measures

Primary Outcomes (6)

• Total Number of Relapses in Year 1

  Relapse is defined as increase in Mayo or partial Mayo score of more than or equal to (\>=) 3 points from clinical response or remission. Mayo score is a discrete ordinal scale with total score ranging from 0 (normal or inactive disease) to 12 (severe disease) and partial Mayo score ranges from 0 (normal or inactive disease) to 9 (severe disease). Relapses will be categorized as: infrequent (less than or equal to \[\<=\] 1 relapse per year), frequent pattern (\>=2 relapses per year) and continuous (persistent symptoms of active ulcerative colitis without a period of remission).

  Year 1

• Total Number of Relapses in Year 3

  Relapse is defined as increase in Mayo or partial Mayo score of \>=3 points from clinical response or remission. Mayo score is a discrete ordinal scale with total score ranging from 0 (normal or inactive disease) to 12 (severe disease) and partial Mayo score ranges from 0 (normal or inactive disease) to 9 (severe disease). Relapses will be categorized as: infrequent (\<=1 relapse per year), frequent pattern (\>=2 relapses per year) and continuous (persistent symptoms of active ulcerative colitis without a period of remission).

  Year 3

• Total Number of Relapses in Year 5

  Relapse is defined as increase in Mayo or partial Mayo score of \>=3 points from clinical response or remission. Mayo score is a discrete ordinal scale with total score ranging from 0 (normal or inactive disease) to 12 (severe disease) and partial Mayo score ranges from 0 (normal or inactive disease) to 9 (severe disease). Relapses will be categorized as: infrequent (\<=1 relapse per year), frequent pattern (\>=2 relapses per year) and continuous (persistent symptoms of active ulcerative colitis without a period of remission).

  Year 5

• Percentage of Participants With Sustained Remission in Year 1

  Clinical remission is \<=2 points with no individual sub-score \>1 point using total or partial Mayo Score. Mayo score is a discrete ordinal scale with total score ranging from 0 (normal or inactive disease) to 12 (severe disease) and partial Mayo Score score ranges from 0 (normal or inactive disease) to 9 (severe disease).

  Year 1

• Percentage of Participants With Sustained Remission in Year 3

  Clinical remission is \<=2 points with no individual sub-score \>1 point using total or partial Mayo Score. Mayo score is a discrete ordinal scale with total score ranging from 0 (normal or inactive disease) to 12 (severe disease) and partial Mayo Score score ranges from 0 (normal or inactive disease) to 9 (severe disease).

  Year 3

• Percentage of Participants With Sustained Remission in Year 5

  Clinical remission is \<=2 points with no individual sub-score \>1 point using total or partial Mayo Score. Mayo score is a discrete ordinal scale with total score ranging from 0 (normal or inactive disease) to 12 (severe disease) and partial Mayo Score score ranges from 0 (normal or inactive disease) to 9 (severe disease).

  Year 5

Secondary Outcomes (13)

• Mean Time to Relapse

  Year 1, 3 and 5

• Percentage of Participants With Sustained Clinical Response

  Year 1, 3 and 5

• Total Number of Ulcerative Colitis-Related Hospitalizations

  Year 3 and 5

• Total Days of Ulcerative Colitis-Related Hospitalizations

  Year 3 and 5

• Percentage of Participants With Colectomy

  Year 3 and 5

Study Arms (1)

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.

Other: No Intervention

Interventions

No Intervention 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.

Newly Diagnosed Moderate to Severe Ulcerative Colitis

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Korea, Ltd., Korea: lead

Study Sites (15)

Unknown Facility

Ansan-si, South Korea

Location

Unknown Facility

Busan, South Korea

Location

Unknown Facility

Cheonan, South Korea

Location

Unknown Facility

Cheongju-si, South Korea

Location

Unknown Facility

Daegu, South Korea

Location

Unknown Facility

Daejeon, South Korea

Location

Unknown Facility

Guri-si, South Korea

Location

Unknown Facility

Gwangju, South Korea

Location

Unknown Facility

Iksan, South Korea

Location

Unknown Facility

Incheon, South Korea

Location

Unknown Facility

Kwanju, South Korea

Location

Unknown Facility

Seongnam-si, South Korea

Location

Unknown Facility

Seoul, South Korea

Location

Unknown Facility

Suwon, South Korea

Location

Unknown Facility

Wŏnju, South Korea

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample will be collected and stored for genetic and biomarker research from participants who agree to give additional informed consent form.

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Janssen Korea, Ltd., Korea Clinical Trial

  Janssen Korea, Ltd., Korea

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2014
• First Posted: September 1, 2014
• Study Start: July 1, 2014
• Primary Completion: February 22, 2022
• Study Completion: February 22, 2022
• Last Updated: April 27, 2025

Record last verified: 2025-04

Locations

KR (15)