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

April 25, 2025 updated by: Janssen Korea, Ltd., Korea

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
368

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Ansan-si, Korea, Republic of
      • Busan, Korea, Republic of
      • Cheonan, Korea, Republic of
      • Cheongju-si, Korea, Republic of
      • Daegu, Korea, Republic of
      • Daejeon, Korea, Republic of
      • Guri-Si, Korea, Republic of
      • Gwangju, Korea, Republic of
      • Iksan, Korea, Republic of
      • Incheon, Korea, Republic of
      • Kwanju, Korea, Republic of
      • Seongnam-Si, Korea, Republic of
      • Seoul, Korea, Republic of
      • Suwon, Korea, Republic of
      • Wonju, Korea, Republic of

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

7 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Participants with newly diagnosed moderate to severe ulcerative colitis in a tertiary referral hospital within 4 weeks before prior to enrollment will be observed.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Year 1
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).
Year 3
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).
Year 5
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).
Year 1
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).
Year 3
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).
Year 5

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Time to Relapse
Time Frame: Year 1, 3 and 5
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.
Year 1, 3 and 5
Percentage of Participants With Sustained Clinical Response
Time Frame: Year 1, 3 and 5
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.
Year 1, 3 and 5
Total Number of Ulcerative Colitis-Related Hospitalizations
Time Frame: Year 3 and 5
Total number of ulcerative colitis-related hospitalizations will be observed.
Year 3 and 5
Total Days of Ulcerative Colitis-Related Hospitalizations
Time Frame: Year 3 and 5
Total days of ulcerative colitis-related hospitalizations will be observed.
Year 3 and 5
Percentage of Participants With Colectomy
Time Frame: Year 3 and 5
Percentage of participants who will be going for surgery to remove part or all of the colon will be observed.
Year 3 and 5
Percentage of Participants With Death
Time Frame: Year 3 and 5
Percentage of participants with death (ulcerative colitis related and non-ulcerative colitis related) will be observed.
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
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.
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
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.
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
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.
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
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.
Baseline, Year 1, 3 and 5
Percentage of Participants Treated With Immune Modulators, Systemic Steroids and Biologics
Time Frame: Baseline up to Year 5
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.
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
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.
Baseline up to Year 5
Number of Participants With Complementary and Alternative Medicine (CAM) use and Satisfaction
Time Frame: Baeline up to Year 5
Number of participants with CAM use and satisfaction will be reported.
Baeline up to Year 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Korea, Ltd., Korea

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Janssen Korea, Ltd., Korea Clinical Trial, Janssen Korea, Ltd., Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 22, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 22, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 28, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 1, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR103116
  • REMICADECRD4016 (Other Identifier: Janssen Korea, Ltd., Korea)
  • INF-KOR-5005 (Other Identifier: Janssen Korea, Ltd., Korea)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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