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A Study of Symptom Improvement of Ulcerative Colitis After an Induction Dose of Ustekinumab in Japanese Clinical Practice

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04963725
Recruitment Status : Active, not recruiting
First Posted : July 15, 2021
Last Update Posted : December 8, 2022
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutical K.K.

Brief Summary:
The purpose of this study is to describe the initial response to ustekinumab induction treatment for ulcerative colitis (UC) in Japan.

Condition or disease Intervention/treatment
Ulcerative Colitis Drug: Ustekinumab

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Study Type : Observational
Actual Enrollment : 122 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Symptom Improvement of Ulcerative Colitis After an Induction Dose of Ustekinumab in Japanese Clinical Practice, Measured Using Patient-Reported Outcomes
Actual Study Start Date : July 18, 2021
Estimated Primary Completion Date : December 14, 2022
Estimated Study Completion Date : March 17, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Ustekinumab

Group/Cohort Intervention/treatment
Participants Initiating Therapy with Ustekinumab
Data will be collected for participants in Japan who have had an inadequate response, or been intolerant to, conventional or biologic therapies. The treating physician has made the decision to initiate ustekinumab induction therapy in the routine clinical practice - either as a first or subsequent biologic therapy initiating for their moderate to severe ulcerative colitis.
Drug: Ustekinumab
No intervention or treatment will be administered as part of this study. Data available per routine clinical practice at clinic visits as well as directly from participant using a smartphone/tablet application will be collected.




Primary Outcome Measures :
  1. Percentage of Participants With a Rectal Bleeding Score of 0 or 1 [ Time Frame: Up to Week 8 ]
    The rectal bleeding scores of 0 and 1 using physician's global assessment will be reported where 0 indicates 'No blood seen' and 1 indicates 'Streaks of blood with stool less than half the time'.

  2. Percentage of Participants With a Stool Frequency Score of 0 or 1 [ Time Frame: Up to Week 8 ]
    The stool bleeding scores of 0 and 1 using physician's global assessment will be reported where 0 will indicate 'Normal number of stools' and 1 will indicate '1 to 2 stools more than normal'.


Secondary Outcome Measures :
  1. Change From Baseline in Rectal Bleeding Score Through Week 8 [ Time Frame: Baseline, Up to Week 8 ]
    Change from baseline in rectal bleeding score through Week 8 will be reported.

  2. Change from Baseline in Stool Frequency Score Through Week 8 [ Time Frame: Baseline, Up to Week 8 ]
    Change from baseline in stool frequency score through Week 8 will be reported.

  3. Percentage of Participants with a Reduction in Rectal Bleeding Score of Greater than or Equal to (>=) 1 From Baseline [ Time Frame: Up to Week 8 ]
    Percentage of participants with a reduction in rectal bleeding score of >= 1 from baseline through Week 8 will be reported.

  4. Percentage of Participants with Reduction in Stool Frequency Score of >= 1 From Baseline [ Time Frame: Up to Week 8 ]
    Percentage of participants with a reduction in stool frequency score of >= 1 from baseline through Week 8 will be reported.

  5. Change from Baseline in Calculated Partial Mayo Score at Week 8 and Week 16 or Week 20 [ Time Frame: Baseline, Week 8 and Week 16 or Week 20 ]
    The partial Mayo (pMayo) is a composite score to indicate ulcerative colitis status without the requirement for endoscopy. It records participant-reported stool frequency over three days relative to normal on a 0-3 subscale (stool frequency, rectal bleeding, and physician global assessment of disease severity) each graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 9; where higher scores indicating more severe disease.

  6. Change from Baseline in Rectal Bleeding Score at Week 16 or Week 20 [ Time Frame: Baseline, Week 16 or Week 20 ]
    Change from baseline in rectal bleeding score Week 16 or Week 20 will be reported.

  7. Change from Baseline in Stool Frequency Score at Week 16 or Week 20 [ Time Frame: Baseline, Week 16 or Week 20 ]
    Change from baseline in stool frequency score at Week 16 or Week 20 will be reported.

  8. Change from Baseline in Abdominal Pain Through Week 8 [ Time Frame: Baseline, Up to Week 8 ]
    Change from baseline in abdominal pain through Week 8 will be reported. Abdominal Pain will be evaluated based on numeric rating scale (NRS) ranging from 0 to 10 with lower score of 0 indicating 'no pain', score of 5 indicating 'moderate pain' and higher score of 10 indicating 'worst pain'. The abdominal pain score represents the most severe pain of the day.

  9. Percentage of Participants with Presence of Nocturnal Diarrhea [ Time Frame: Up to Week 8 ]
    Percentage of participants with presence of nocturnal diarrhea will be reported. Nocturnal Diarrhea will be evaluated based on 'Yes/No' questionnaire, completed by participants using a smartphone/tablet-based application.

  10. Percentage of Participants with Presence of Tenesmus [ Time Frame: Up to Week 8 ]
    Percentage of participants with presence of tenesmus will be reported. Tenesmus will be evaluated based on 'Yes/No' questionnaire, completed by participants using a smartphone/tablet-based application.

  11. Percentage of Participants with Perceived Improvement in Ulcerative Colitis (UC) [ Time Frame: Up to Week 8 ]
    Percentage of participants with perceived improvement in UC will be reported. Perceived Improvement in UC will be evaluated based on NRS ranging from 0 to 10 with lower score of 0 indicating 'completely better (no UC symptoms)', score of 5 indicating 'starting condition (condition immediately before the induction of ustekinumab)' and higher score of 10 indicating 'poor condition (lots of UC symptoms).' Improvement is shown by recording a number less than 5 and worsening by recording a number greater than 5.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Study population will consist of participants who have had previously inadequate response, or have been intolerant to, conventional or biologic therapies and will be initiating ustekinumab for their ulcerative colitis.
Criteria

Inclusion Criteria:

  • Must have a confirmed diagnosis of ulcerative colitis (UC) in accordance with local practice
  • Has a current UC severity that is judged by the treating physician to be moderate to severe (being a partial Mayo score of 5 to 9, inclusive)
  • A decision has been made by the treating physician and the participant within routine clinical practice to commence treatment with ustekinumab, having been deemed to have an inadequate response to, or intolerant to, previous UC therapy
  • Must sign an informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements. If the participant is 16 to 19, informed consent might be obtained from each study participant according to the regulation of institution/hospital and their legally acceptable representative must sign an ICF
  • Must be able to read, understand, and complete participant-reported outcome instruments, and intend to cooperate with completion of participant-reported outcome instruments using smartphone/tablet

Exclusion Criteria:

  • Has ever previously received ustekinumab (including clinical trial use)
  • Are currently receiving, or have received within the past 3 months, systemic treatment with a biologic therapy for any other indication (example Crohn's disease, psoriasis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis)
  • Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 3 months before the start of the study or the first data collection time point
  • Currently enrolled in an interventional study or another Janssen-sponsored observational study (including post-marketing surveillance)
  • Based on physician judgement has i) severe extensive colitis and is at imminent risk of colectomy OR ii) a stoma or history of a fistula OR iii) previously had extensive colonic resection (example, less than 30 centimeter (cm) of colon remaining) OR iv) current fulminant colitis OR v) currently hospitalized for worsening of UC-related symptoms (not excluded if the reason for hospitalization is first dose of ustekinumab)

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): NCT04963725


Locations
Show Show 24 study locations
Sponsors and Collaborators
Janssen Pharmaceutical K.K.
Investigators
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Study Director: Janssen Pharmaceutical K.K., Japan Clinical Trial Janssen Pharmaceutical K.K.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier: NCT04963725    
Other Study ID Numbers: CR108984
CNTO1275UCO4004 ( Other Identifier: Janssen Pharmaceutical K.K., Japan )
First Posted: July 15, 2021    Key Record Dates
Last Update Posted: December 8, 2022
Last Verified: December 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Ustekinumab
Dermatologic Agents