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

NCT04963725 | Completed

• 2 other identifiers: CR108984CNTO1275UCO4004
• Study Type: observational
• Target: 137
• Locations: 1 country
• Sites: 23

Brief Summary

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

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• Change From Baseline in Rectal Bleeding Score Through Week 8

  Baseline, Up to Week 8

• Change from Baseline in Stool Frequency Score Through Week 8

  Baseline, Up to Week 8

• 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 Reduction in Stool Frequency Score of >= 1 From Baseline

  Up to Week 8

• 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

Study Arms (1)

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

Interventions

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.

Participants Initiating Therapy with Ustekinumab

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Janssen Pharmaceutical K.K.: lead

Study Sites (23)

Tokyo Medical and Dental University Hospital

Bunkyō City, 113 8519, Japan

Location

Juntendo University Hospital

Bunkyō City, 113-8431, Japan

Location

Chiba University Hospital

Chiba, 260 8677, Japan

Location

Toho University Sakura Medical Center

Chiba, 285-8741, Japan

Location

Kyushu University Hospital

Fukuoka, 812 8582, Japan

Location

Fukuoka University Hospital

Fukuoka, 814-0180, Japan

Location

Hamamatsu University Hospital

Hamamatsu, 431 3192, Japan

Location

Shimane University Hospital

Izumo, 693-8501, Japan

Location

Tsujinaka Hospital Kashiwanoha

Kashiwa, 277-0871, Japan

Location

Saitama Medical University Saitama Medical Center

Kawagoe, 350-8550, Japan

Location

University Hospital Kyoto Prefectural University of Medicine

Kyoto, 602-8566, Japan

Location

Kitasato University Kitasato Institute Hospital

Minatoku, 108-8642, Japan

Location

Kyorin University Hospital

Mitaka, 181-8611, Japan

Location

Nagoya University Hospital

Nagoya, 466 8560, Japan

Location

Okayama University Hospital

Okayama, 700 8558, Japan

Location

Ishida Clinic of IBD and Gastroenterology

Ōita, 870-0823, Japan

Location

Shiga University of Medical Science Hospital

Ōtsu, 520-2192, Japan

Location

Sapporo Medical University Hospital

Sapporo, 060-8543, Japan

Location

Tohoku University Hospital

Sendai, 980 8574, Japan

Location

Tokyo Yamate Medical Center

Shinjuku-ku, 169-0073, Japan

Location

Osaka Medical and Pharmaceutical University Hospital

Takatsuki, 569-8686, Japan

Location

Toyama Prefectural Central Hospital

Toyama, 930 8550, Japan

Location

Yokkaichi Hazu Medical Center

Yokkaichi, 510-0016, Japan

Location

Related Publications (1)

• 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.

  PMID: 35508346 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Ustekinumab

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Janssen Pharmaceutical K.K., Japan Clinical Trial

  Janssen Pharmaceutical K.K.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2021
• First Posted: July 15, 2021
• Study Start: July 18, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: April 28, 2025

Record last verified: 2025-04

Locations

JP (23)