A Study of Symptom Improvement of Ulcerative Colitis After an Induction Dose of Ustekinumab in Japanese Clinical Practice
NCT ID: NCT04963725
Last Updated: 2025-04-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
137 participants
OBSERVATIONAL
2021-07-18
2022-12-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of Adalimumab in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis
NCT00853099
A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis
NCT02407236
Real-world Effectiveness of Ustekinumab in Participants Suffering From Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis) With Extra-intestinal Manifestations or Immune-mediated Inflammatory Diseases
NCT03606499
Long-term Safety and Efficacy Study of Adalimumab in Pediatric Subjects With Ulcerative Colitis
NCT02632175
A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis (UC)
NCT04630028
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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)
16 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Janssen Pharmaceutical K.K.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Janssen Pharmaceutical K.K., Japan Clinical Trial
Role: STUDY_DIRECTOR
Janssen Pharmaceutical K.K.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Tokyo Medical and Dental University Hospital
Bunkyō City, , Japan
Juntendo University Hospital
Bunkyō City, , Japan
Chiba University Hospital
Chiba, , Japan
Toho University Sakura Medical Center
Chiba, , Japan
Kyushu University Hospital
Fukuoka, , Japan
Fukuoka University Hospital
Fukuoka, , Japan
Hamamatsu University Hospital
Hamamatsu, , Japan
Shimane University Hospital
Izumo, , Japan
Tsujinaka Hospital Kashiwanoha
Kashiwa, , Japan
Saitama Medical University Saitama Medical Center
Kawagoe, , Japan
University Hospital Kyoto Prefectural University of Medicine
Kyoto, , Japan
Kitasato University Kitasato Institute Hospital
Minatoku, , Japan
Kyorin University Hospital
Mitaka, , Japan
Nagoya University Hospital
Nagoya, , Japan
Okayama University Hospital
Okayama, , Japan
Ishida Clinic of IBD and Gastroenterology
Ōita, , Japan
Shiga University of Medical Science Hospital
Ōtsu, , Japan
Sapporo Medical University Hospital
Sapporo, , Japan
Tohoku University Hospital
Sendai, , Japan
Tokyo Yamate Medical Center
Shinjuku-ku, , Japan
Osaka Medical and Pharmaceutical University Hospital
Takatsuki, , Japan
Toyama Prefectural Central Hospital
Toyama, , Japan
Yokkaichi Hazu Medical Center
Yokkaichi, , Japan
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CNTO1275UCO4004
Identifier Type: OTHER
Identifier Source: secondary_id
CR108984
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.