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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 16 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04963725
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Janssen Pharmaceutical K.K.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Janssen Pharmaceutical K.K., Japan Clinical Trial
Principal Investigator Affiliation Janssen Pharmaceutical K.K.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Japan
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Ulcerative Colitis
Arms & Interventions

Arms

: 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.

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Juntendo University Hospital, Bunkyo-ku, Japan

Status

Recruiting

Address

Juntendo University Hospital

Bunkyo-ku, , 113-8431

Bunkyo-Ku, Japan

Status

Recruiting

Address

Tokyo Medical and Dental University Hospital

Bunkyo-Ku, , 113-8519

Chiba University Hospital, Chiba, Japan

Status

Recruiting

Address

Chiba University Hospital

Chiba, , 260-8677

Toho University Sakura Medical Center, Chiba, Japan

Status

Recruiting

Address

Toho University Sakura Medical Center

Chiba, , 285-8741

Kyushu University Hospital, Fukuoka, Japan

Status

Recruiting

Address

Kyushu University Hospital

Fukuoka, , 812-8582

Fukuoka University Hospital, Fukuoka, Japan

Status

Recruiting

Address

Fukuoka University Hospital

Fukuoka, , 814-0180

Hamamatsu University Hospital, Hamamatsu, Japan

Status

Recruiting

Address

Hamamatsu University Hospital

Hamamatsu, , 431-3192

Tsujinaka Hospital Kashiwanoha, Kashiwa, Japan

Status

Recruiting

Address

Tsujinaka Hospital Kashiwanoha

Kashiwa, , 277-0871

Kawagoe, Japan

Status

Recruiting

Address

Saitama Medical University Saitama Medical Center

Kawagoe, , 350-8550

Kyoto, Japan

Status

Recruiting

Address

University Hospital Kyoto Perfectural University of Medicine

Kyoto, , 602-8566

Minato-ku, Japan

Status

Recruiting

Address

Kitasato University Kitasato Institute Hospital

Minato-ku, , 108-8642

Kyorin University Hospital, Mitaka, Japan

Status

Not yet recruiting

Address

Kyorin University Hospital

Mitaka, , 181-8611

Nagoya University Hospital, Nagoya, Japan

Status

Recruiting

Address

Nagoya University Hospital

Nagoya, , 466-8560

Oita, Japan

Status

Recruiting

Address

Ishida Clinic of IBD and Gastroenterology

Oita, , 870-0823

Okayama University Hospital, Okayama, Japan

Status

Recruiting

Address

Okayama University Hospital

Okayama, , 700-8558

Otsu, Japan

Status

Recruiting

Address

Shiga University of Medical Science Hospital

Otsu, , 520-2192

Sapporo Medical University Hospital, Sapporo, Japan

Status

Recruiting

Address

Sapporo Medical University Hospital

Sapporo, , 060-8543

Tohoku University Hospital, Sendai, Japan

Status

Recruiting

Address

Tohoku University Hospital

Sendai, , 980-8574

Takatsuki, Japan

Status

Recruiting

Address

Osaka Medical and Pharmaceutical University Hospital

Takatsuki, , 569-8686

Tokyo Yamate Medical Center, Tokyo, Japan

Status

Recruiting

Address

Tokyo Yamate Medical Center

Tokyo, , 169-0073

Toyama Prefectural Central Hospital, Toyama, Japan

Status

Recruiting

Address

Toyama Prefectural Central Hospital

Toyama, , 930-8550

Fujita Health University Hospital, Toyoake, Japan

Status

Recruiting

Address

Fujita Health University Hospital

Toyoake, , 470-1192

Yokkaichi Hazu Medical Center, Yokkaichi, Japan

Status

Recruiting

Address

Yokkaichi Hazu Medical Center

Yokkaichi, , 510-0016

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