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Trial record 36 of 36 for:    complementary and alternative medicine AND Survey

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

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ClinicalTrials.gov Identifier: NCT02229344
Recruitment Status : Active, not recruiting
First Posted : September 1, 2014
Last Update Posted : October 4, 2018
Sponsor:
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea

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.

Condition or disease Intervention/treatment
Colitis, Ulcerative Other: No Intervention

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 : Observational
Actual Enrollment : 368 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cohort Study of Newly Diagnosed Moderate to Severe Ulcerative Colitis in Tertiary Referral Hospital Setting in Korea
Actual Study Start Date : July 1, 2014
Estimated Primary Completion Date : February 22, 2022
Estimated Study Completion Date : February 28, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. 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).

  2. 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).

  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).

  4. 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).

  5. 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).

  6. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Total Number of Ulcerative Colitis-Related Hospitalizations [ Time Frame: Year 3 and 5 ]
    Total number of ulcerative colitis-related hospitalizations will be observed.

  4. Total Days of Ulcerative Colitis-Related Hospitalizations [ Time Frame: Year 3 and 5 ]
    Total days of ulcerative colitis-related hospitalizations will be observed.

  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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.


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.


Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02229344


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
Sponsors and Collaborators
Janssen Korea, Ltd., Korea
Investigators
Study Director: Janssen Korea, Ltd., Korea Clinical Trial Janssen Korea, Ltd., Korea

Responsible Party: Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier: NCT02229344     History of Changes
Other Study ID Numbers: CR103116
REMICADECRD4016 ( Other Identifier: Janssen Korea, Ltd., Korea )
INF-KOR-5005 ( Other Identifier: Janssen Korea, Ltd., Korea )
First Posted: September 1, 2014    Key Record Dates
Last Update Posted: October 4, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Janssen Korea, Ltd., Korea:
colitis, ulcerative
MOSAIK
REMICADE
Infliximab

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases