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

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

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

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: Ustekinumab

• Study Type: Observational
• Enrollment (Actual): 137

Contacts and Locations

Study Locations

• Japan
  • Bunkyo Ku, Japan, 113 8519
    • Tokyo Medical and Dental University Hospital
  • Bunkyo-ku, Japan, 113-8431
    • Juntendo University Hospital
  • Chiba, Japan, 285-8741
    • Toho University Sakura Medical Center
  • Chiba, Japan, 260 8677
    • Chiba University Hospital
  • Fukuoka, Japan, 814-0180
    • Fukuoka University Hospital
  • Fukuoka, Japan, 812 8582
    • Kyushu University Hospital
  • Hamamatsu, Japan, 431 3192
    • Hamamatsu University Hospital
  • Izumo, Japan, 693-8501
    • Shimane University Hospital
  • Kashiwa, Japan, 277-0871
    • Tsujinaka Hospital Kashiwanoha
  • Kawagoe, Japan, 350-8550
    • Saitama Medical University Saitama Medical Center
  • Kyoto, Japan, 602-8566
    • University Hospital Kyoto Prefectural University of Medicine
  • Minato-ku, Japan, 108-8642
    • Kitasato University Kitasato Institute Hospital
  • Mitaka, Japan, 181-8611
    • Kyorin University Hospital
  • Nagoya, Japan, 466 8560
    • Nagoya University Hospital
  • Oita, Japan, 870-0823
    • Ishida Clinic of IBD and Gastroenterology
  • Okayama, Japan, 700 8558
    • Okayama University Hospital
  • Otsu, Japan, 520-2192
    • Shiga University of Medical Science Hospital
  • Sapporo, Japan, 060-8543
    • Sapporo Medical University Hospital
  • Sendai, Japan, 980 8574
    • Tohoku University Hospital
  • Shinjuku-ku, Japan, 169-0073
    • Tokyo Yamate Medical Center
  • Takatsuki, Japan, 569-8686
    • Osaka Medical and Pharmaceutical University Hospital
  • Toyama, Japan, 930 8550
    • Toyama Prefectural Central Hospital
  • Yokkaichi, Japan, 510-0016
    • Yokkaichi Hazu Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• 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.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With a Rectal Bleeding Score of 0 or 1	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'.	Up to Week 8
Percentage of Participants With a Stool Frequency Score of 0 or 1	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'.	Up to Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Rectal Bleeding Score Through Week 8	Change from baseline in rectal bleeding score through Week 8 will be reported.	Baseline, Up to Week 8
Change from Baseline in Stool Frequency Score Through Week 8	Change from baseline in stool frequency score through Week 8 will be reported.	Baseline, Up to Week 8
Percentage of Participants with a Reduction in Rectal Bleeding Score of Greater than or Equal to (>=) 1 From Baseline	Percentage of participants with a reduction in rectal bleeding score of >= 1 from baseline through Week 8 will be reported.	Up to Week 8
Percentage of Participants with Reduction in Stool Frequency Score of >= 1 From Baseline	Percentage of participants with a reduction in stool frequency score of >= 1 from baseline through Week 8 will be reported.	Up to Week 8
Change from Baseline in Calculated Partial Mayo Score at 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.	Baseline, Week 8 and Week 16 or Week 20
Change from Baseline in Rectal Bleeding Score at Week 16 or Week 20	Change from baseline in rectal bleeding score Week 16 or Week 20 will be reported.	Baseline, Week 16 or Week 20
Change from Baseline in Stool Frequency Score at Week 16 or Week 20	Change from baseline in stool frequency score at Week 16 or Week 20 will be reported.	Baseline, Week 16 or Week 20
Change from Baseline in Abdominal Pain Through 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.	Baseline, Up to Week 8
Percentage of Participants with Presence of Nocturnal Diarrhea	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.	Up to Week 8
Percentage of Participants with Presence of Tenesmus	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.	Up to Week 8
Percentage of Participants with Perceived Improvement in Ulcerative Colitis (UC)	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.	Up to Week 8

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Matsuoka K, Nagano K, Nagasaki S, Murata Y, Hisamatsu T. Symptom Improvement of ulceRative colitis after an Induction dose of UStekinumab in Japanese clinical practice (SIRIUS), measured using patient-reported outcomes: a prospective observational study. BMJ Open. 2022 May 4;12(5):e060081. doi: 10.1136/bmjopen-2021-060081.

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2021
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: July 8, 2021
• First Submitted That Met QC Criteria: July 8, 2021
• First Posted (Actual): July 15, 2021

Study Record Updates

• Last Update Posted (Actual): April 28, 2025
• Last Update Submitted That Met QC Criteria: April 25, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; Ulcer; Dermatologic Agents; Ustekinumab
• Other Study ID Numbers: CR108984; CNTO1275UCO4004 (Other Identifier: Janssen Pharmaceutical K.K., Japan)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No