Colitis, UlcerativeMOSAIKNCT02229344

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

An observational study of Colitis, Ulcerative, run by Janssen Korea, Ltd., Korea at 15 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 7 years and older
Conditions the study is for: Colitis, Ulcerative
How many people: 368 participants
Where: 15 sitesSouth Korea
Study dates: 1 Jul 2014to 22 Feb 2022
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 7 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

South Korea15 sites

Study site
Ansan-si
Study site
Busan
Study site
Cheonan
Study site
Cheongju-si
Study site
Daegu
Study site
Daejeon
Study site
Guri-si
Study site
Gwangju
Study site
Iksan
Study site
Incheon
Study site
Kwanju
Study site
Seongnam-si
Study site
Seoul
Study site
Suwon
Study site
Wŏnju

Other trials in South Korea

About this study

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

Read the 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
Being tested: No Intervention
Keywords: colitis, ulcerative, MOSAIK, REMICADE, Infliximab
Medical subject headings: Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT02229344
Study group	Role	What they receive
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. Receives: Other: No Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Year 5

Secondary outcomes (13)

Mean Time to Relapse
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). Average time taken to occurrence of first relapse will be observed.
Measured: Year 1, 3 and 5
Percentage of Participants With Sustained Clinical Response
Response is defined as decrease in Mayo or partial Mayo score of >=3 points from Baseline and decrease in Mayo score of >=30 percent (%) from Baseline and decrease in the rectal bleeding score >=1 or an absolute rectal bleeding score of 0 or 1.
Measured: Year 1, 3 and 5
Total Number of Ulcerative Colitis-Related Hospitalizations
Total number of ulcerative colitis-related hospitalizations will be observed.
Measured: Year 3 and 5
Total Days of Ulcerative Colitis-Related Hospitalizations
Total days of ulcerative colitis-related hospitalizations will be observed.
Measured: Year 3 and 5
Percentage of Participants With Colectomy
Percentage of participants who will be going for surgery to remove part or all of the colon will be observed.
Measured: Year 3 and 5
Percentage of Participants With Death
Percentage of participants with death (ulcerative colitis related and non-ulcerative colitis related) will be observed.
Measured: Year 3 and 5
Mean Change From Baseline in Disease Extent at Year 1, 3 and 5
Colonoscopy (a medical examination of the colon by a physician using a colonoscope) will be conducted to explore the extent of lesion to determine extent of disease.
Measured: Baseline, Year 1, 3 and 5
Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Year 1, 3 and 5
The IBDQ evaluates the effect of the participants' inflammatory bowel disease on the quality of life Scores range from 32 to 224 with higher scores indicating better quality of life.
Measured: Baseline and Year 1, 3 and 5
Mean Change From Baseline in Short Form Survey (SF 12) Score at Year 1, 3 and 5
The SF12 is a generic measure physical and mental health, it is is weighted and summed to provide easily interpretable scales. Physical and Mental Health Composite Scores (PCS \& MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
Measured: Baseline, Year 1, 3 and 5
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score at Year 1, 3 and 5
The HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 14 items, and each item is rated on a four-point scale (0-3). All seven answers are summarized and calculated to a total score to the anxiety scale and to the depression scale with a maximum score of 21 points for each scale.
Measured: Baseline, Year 1, 3 and 5
Percentage of Participants Treated With Immune Modulators, Systemic Steroids and Biologics
Percentage of participants treated with immune modulators (azathioprine or 6-mercaptoprine at least a consecutive 3-month course), systemic steroids and biologics will be reported.
Measured: Baseline up to Year 5
Mean Time to First Treatment With Immune Modulators, Systemic Steroids and Biologics From Baseline
Time to first administration of immune modulators like azathioprine or 6-mercaptoprine for at least a consecutive 3-month course, systemic steroids and biologics from Baseline will be observed.
Measured: Baseline up to Year 5
Number of Participants With Complementary and Alternative Medicine (CAM) use and Satisfaction
Number of participants with CAM use and satisfaction will be reported.
Measured: Baeline up to Year 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 201422 Feb 2022

First posted1 Sep 2014 (estimated)
Study start1 Jul 2014
Primary completion22 Feb 2022
Study completion22 Feb 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Colitis, UlcerativeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 368 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02229344
Sponsor's protocol ID: CR103116
Other IDs: REMICADECRD4016, INF-KOR-5005
Acronym: MOSAIK
Status last verified: Apr 2025
First submitted: 28 Aug 2014
Last updated: 27 Apr 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis
Ulcerative Colitis
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Ibd CAncer and seRious Infections in France (I-CARE 2)
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MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
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All Colitis, Ulcerative trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cohort Study of Newly Diagnosed Moderate to Severe Ulcerative Colitis in Tertiary Referral Hospital Setting in Korea
ClinicalTrials.gov ID: NCT02229344
Acronym / sponsor ID: MOSAIK / CR103116
Conditions: Colitis, Ulcerative
Keywords: colitis, ulcerative, MOSAIK, REMICADE, Infliximab
Study type: Observational
Recruitment status: Completed
Enrolment: 368 participants (actual)
Lead sponsor: Janssen Korea, Ltd., KoreaIndustry (pharma, biotech, devices)
Study start: 1 Jul 2014 (actual)
Primary completion: 22 Feb 2022 (actual)
Study completion: 22 Feb 2022 (actual)
First posted: 1 Sep 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Newly Diagnosed Moderate to Severe Ulcerative Colitis	–	Other: No InterventionParticipants with newly diagnosed moderate to severe ulcerative colitis in a tertiary referral hospital within 4 weeks before prior to enrollment will be observed.

Who may qualify

Ages: 7 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
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.

Key inclusion criteria (5 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
No InterventionParticipants with newly diagnosed moderate to severe ulcerative colitis in a tertiary referral hospital within 4 weeks before prior to enrollment will be observed.	Other	Newly Diagnosed Moderate to Severe Ulcerative Colitis

Primary outcome

Total Number of Relapses in Year 1
Time frame: 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).
Total Number of Relapses in Year 3
Time frame: 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).
Total Number of Relapses in Year 5
Time frame: 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).
Percentage of Participants With Sustained Remission in Year 1
Time frame: 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).
Percentage of Participants With Sustained Remission in Year 3
Time frame: 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).
Percentage of Participants With Sustained Remission in Year 5
Time frame: 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).

13 secondary outcomes

Mean Time to Relapse
Time frame: Year 1, 3 and 5
Percentage of Participants With Sustained Clinical Response
Time frame: Year 1, 3 and 5
Total Number of Ulcerative Colitis-Related Hospitalizations
Time frame: Year 3 and 5
Total Days of Ulcerative Colitis-Related Hospitalizations
Time frame: Year 3 and 5
Percentage of Participants With Colectomy
Time frame: Year 3 and 5
Percentage of Participants With Death
Time frame: Year 3 and 5
Mean Change From Baseline in Disease Extent at Year 1, 3 and 5
Time frame: Baseline, Year 1, 3 and 5
Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Year 1, 3 and 5
Time frame: Baseline and Year 1, 3 and 5
Mean Change From Baseline in Short Form Survey (SF 12) Score at Year 1, 3 and 5
Time frame: Baseline, Year 1, 3 and 5
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score at Year 1, 3 and 5
Time frame: Baseline, Year 1, 3 and 5
Percentage of Participants Treated With Immune Modulators, Systemic Steroids and Biologics
Time frame: Baseline up to Year 5
Mean Time to First Treatment With Immune Modulators, Systemic Steroids and Biologics From Baseline
Time frame: Baseline up to Year 5
Number of Participants With Complementary and Alternative Medicine (CAM) use and Satisfaction
Time frame: Baeline up to Year 5

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.

Related trials for Colitis, Ulcerative

Active, not recruitingPhase 3
An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Janssen Korea, Ltd., Korea Clinical Trial study director

Janssen Korea, Ltd., Korea

15 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Colitis, Ulcerative, run by Janssen Korea, Ltd., Korea at 15 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Number of Relapses in Year 1 (time frame: Year 1). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02229344.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025; AzTrials last refreshed its copy on 8 Nov 2026.