Clinical trial NCT02229344: Study of Clinical Course of Newly Diagnosed Moderate to Severe Ulcerative Colitis in Korea
Official title: Cohort Study of Newly Diagnosed Moderate to Severe Ulcerative Colitis in Tertiary Referral Hospital Setting in Korea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colitis, Ulcerative
Keywords: colitis, ulcerative
MOSAIK
REMICADE
Infliximab
Lead sponsor: Janssen Korea, Ltd., Korea
Sponsor class: INDUSTRY
First posted: 2014-09-01
Enrollment: 368
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

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

Primary outcomes:
measure: Total Number of Relapses in Year 1
timeFrame: Year 1
measure: Total Number of Relapses in Year 3
timeFrame: Year 3
measure: Total Number of Relapses in Year 5
timeFrame: Year 5
measure: Percentage of Participants With Sustained Remission in Year 1
timeFrame: Year 1
measure: Percentage of Participants With Sustained Remission in Year 3
timeFrame: Year 3
measure: Percentage of Participants With Sustained Remission in Year 5
timeFrame: Year 5
Secondary outcomes:
measure: Mean Time to Relapse
timeFrame: Year 1, 3 and 5
measure: Percentage of Participants With Sustained Clinical Response
timeFrame: Year 1, 3 and 5
measure: Total Number of Ulcerative Colitis-Related Hospitalizations
timeFrame: Year 3 and 5
measure: Total Days of Ulcerative Colitis-Related Hospitalizations
timeFrame: Year 3 and 5
measure: Percentage of Participants With Colectomy
timeFrame: Year 3 and 5
measure: Percentage of Participants With Death
timeFrame: Year 3 and 5
measure: Mean Change From Baseline in Disease Extent at Year 1, 3 and 5
timeFrame: Baseline, Year 1, 3 and 5
measure: Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Year 1, 3 and 5
timeFrame: Baseline and Year 1, 3 and 5
measure: Mean Change From Baseline in Short Form Survey (SF 12) Score at Year 1, 3 and 5
timeFrame: Baseline, Year 1, 3 and 5
measure: Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score at Year 1, 3 and 5
timeFrame: Baseline, Year 1, 3 and 5
measure: Percentage of Participants Treated With Immune Modulators, Systemic Steroids and Biologics
timeFrame: Baseline up to Year 5
measure: Mean Time to First Treatment With Immune Modulators, Systemic Steroids and Biologics From Baseline
timeFrame: Baseline up to Year 5
measure: Number of Participants With Complementary and Alternative Medicine (CAM) use and Satisfaction
timeFrame: Baeline up to Year 5
Other outcomes:
Locations:
city: Ansan-si
country: Korea, Republic of
city: Busan
country: Korea, Republic of
city: Cheonan
country: Korea, Republic of
city: Cheongju-si
country: Korea, Republic of
city: Daegu
country: Korea, Republic of
city: Daejeon
country: Korea, Republic of
city: Guri-Si
country: Korea, Republic of
city: Gwangju
country: Korea, Republic of
city: Iksan
country: Korea, Republic of
city: Incheon
country: Korea, Republic of
city: Kwanju
country: Korea, Republic of
city: Seongnam-Si
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Suwon
country: Korea, Republic of
city: Wonju
country: Korea, Republic of
Study officials:
affiliation: Janssen Korea, Ltd., Korea
name: Janssen Korea, Ltd., Korea Clinical Trial
role: STUDY_DIRECTOR
References: