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

Sponsor
Janssen Pharmaceutical K.K. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04963725
Collaborator
(none)
122
24
19.9
5.1
0.3

Study Details

Study Description

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 Phase

Study Design

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 :
Jul 18, 2021
Anticipated Primary Completion Date :
Dec 15, 2022
Anticipated Study Completion Date :
Mar 17, 2023

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Percentage of Participants With a Rectal Bleeding Score of 0 or 1 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Juntendo University Hospital Bunkyo-ku Japan 113-8431
2 Tokyo Medical and Dental University Hospital Bunkyo-Ku Japan 113-8519
3 Chiba University Hospital Chiba Japan 260-8677
4 Toho University Sakura Medical Center Chiba Japan 285-8741
5 Kyushu University Hospital Fukuoka Japan 812-8582
6 Fukuoka University Hospital Fukuoka Japan 814-0180
7 Hamamatsu University Hospital Hamamatsu Japan 431-3192
8 Shimane University Hospital Izumo Japan 693-8501
9 Tsujinaka Hospital Kashiwanoha Kashiwa Japan 277-0871
10 Saitama Medical University Saitama Medical Center Kawagoe Japan 350-8550
11 University Hospital Kyoto Perfectural University of Medicine Kyoto Japan 602-8566
12 Kitasato University Kitasato Institute Hospital Minato-ku Japan 108-8642
13 Kyorin University Hospital Mitaka Japan 181-8611
14 Nagoya University Hospital Nagoya Japan 466-8560
15 Ishida Clinic of IBD and Gastroenterology Oita Japan 870-0823
16 Okayama University Hospital Okayama Japan 700-8558
17 Shiga University of Medical Science Hospital Otsu Japan 520-2192
18 Sapporo Medical University Hospital Sapporo Japan 060-8543
19 Tohoku University Hospital Sendai Japan 980-8574
20 Osaka Medical and Pharmaceutical University Hospital Takatsuki Japan 569-8686
21 Tokyo Yamate Medical Center Tokyo Japan 169-0073
22 Toyama Prefectural Central Hospital Toyama Japan 930-8550
23 Fujita Health University Hospital Toyoake Japan 470-1192
24 Yokkaichi Hazu Medical Center Yokkaichi Japan 510-0016

Sponsors and Collaborators

  • Janssen Pharmaceutical K.K.

Investigators

  • Study Director: Janssen Pharmaceutical K.K., Japan Clinical Trial, Janssen Pharmaceutical K.K.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier:
NCT04963725
Other Study ID Numbers:
  • CR108984
  • CNTO1275UCO4004
First Posted:
Jul 15, 2021
Last Update Posted:
Aug 18, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 18, 2022