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Completed

NCT Number: NCT04963725

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

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

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Juntendo University Hospital, Bunkyō City, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Ustekinumab

Drug

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Janssen Pharmaceutical K.K.

Industry

Registry information

Official study title

Symptom Improvement of Ulcerative Colitis After an Induction Dose of Ustekinumab in Japanese Clinical Practice, Measured Using Patient-Reported Outcomes

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 15, 2021
Registry last updated
Apr 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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