Ulcerative ColitisNCT04963725
A Study of Symptom Improvement of Ulcerative Colitis After an Induction Dose of Ustekinumab in Japanese Clinical Practice
An observational study of Ulcerative Colitis, run by Janssen Pharmaceutical K.K. at 23 sites in Japan.
Trial summary
The purpose of this study is to describe the initial response to ustekinumab induction treatment for ulcerative colitis (UC) in Japan. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Ustekinumab
- Type of treatment
- Pill or oral medicine
- How many people
- 137 participants
- Where
- 23 sitesJapan
- Study dates
- 18 Jul 2021to 1 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
23 sites in 1 country.
23 sites in 1 country
Japan23 sites
Tokyo Medical and Dental University Hospital
Bunkyō City, 113 8519
Juntendo University Hospital
Bunkyō City, 113-8431
Chiba University Hospital
Chiba, 260 8677
Toho University Sakura Medical Center
Chiba, 285-8741
Kyushu University Hospital
Fukuoka, 812 8582
Fukuoka University Hospital
Fukuoka, 814-0180
Hamamatsu University Hospital
Hamamatsu, 431 3192
Shimane University Hospital
Izumo, 693-8501
Tsujinaka Hospital Kashiwanoha
Kashiwa, 277-0871
Saitama Medical University Saitama Medical Center
Kawagoe, 350-8550
University Hospital Kyoto Prefectural University of Medicine
Kyoto, 602-8566
Kitasato University Kitasato Institute Hospital
Minatoku, 108-8642
Kyorin University Hospital
Mitaka, 181-8611
Nagoya University Hospital
Nagoya, 466 8560
Ishida Clinic of IBD and Gastroenterology
Ōita, 870-0823
Okayama University Hospital
Okayama, 700 8558
Shiga University of Medical Science Hospital
Ōtsu, 520-2192
Sapporo Medical University Hospital
Sapporo, 060-8543
Tohoku University Hospital
Sendai, 980 8574
Tokyo Yamate Medical Center
Shinjuku-ku, 169-0073
Osaka Medical and Pharmaceutical University Hospital
Takatsuki, 569-8686
Toyama Prefectural Central Hospital
Toyama, 930 8550
Yokkaichi Hazu Medical Center
Yokkaichi, 510-0016
About this study
Official title: 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.
- Conditions
- Ulcerative Colitis
- Being tested
- Ustekinumab
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UstekinumabDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Ustekinumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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'.
Measured: 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'.
Measured: Up to Week 8
Secondary outcomes (11)
Change From Baseline in Rectal Bleeding Score Through Week 8
Change from baseline in rectal bleeding score through Week 8 will be reported.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start18 Jul 2021
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Pharmaceutical K.K.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Pharmaceutical K.K., Japan Clinical Trial, Study director, Janssen Pharmaceutical K.K.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04963725
- Sponsor's protocol ID
- CR108984
- Other IDs
- CNTO1275UCO4004
- Status last verified
- Apr 2025
- First submitted
- 8 Jul 2021
- Last updated
- 28 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nagano K, Emoto S, Nishimura Y, Sugi M, Amano M, Yoshigoe S, Nishimura K, Matsuoka K. Using Pre-Study Patient Interviews to Refine Electronic Patient-Reported Outcomes in Clinical Research of Ustekinumab Induction for Ulcerative Colitis (SIRIUS Study). Adv Ther. 2026 Sep 21. doi: 10.1007/s12325-026-03770-6. Online ahead of print.
PubMed 42766096Matsuoka 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.
PubMed 35508346
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptom Improvement of Ulcerative Colitis After an Induction Dose of Ustekinumab in Japanese Clinical Practice, Measured Using Patient-Reported Outcomes
- ClinicalTrials.gov ID
- NCT04963725
- Acronym / sponsor ID
- CR108984
- Conditions
- Ulcerative Colitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Janssen Pharmaceutical K.K.Industry (pharma, biotech, devices)
- Study start
- 18 Jul 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 15 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to describe the initial response to ustekinumab induction treatment for ulcerative colitis (UC) in Japan.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants Initiating Therapy with Ustekinumab | – | Drug: UstekinumabData 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UstekinumabNo 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. | Drug | Participants Initiating Therapy with Ustekinumab |
Primary outcome
Percentage of Participants With a Rectal Bleeding Score of 0 or 1
Time frame: 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'.
Percentage of Participants With a Stool Frequency Score of 0 or 1
Time frame: 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'.
11 secondary outcomes
Change From Baseline in Rectal Bleeding Score Through Week 8
Time frame: Baseline, Up to Week 8
Change from Baseline in Stool Frequency Score Through Week 8
Time frame: Baseline, Up to Week 8
Percentage of Participants with a Reduction in Rectal Bleeding Score of Greater than or Equal to (>=) 1 From Baseline
Time frame: Up to Week 8
Percentage of Participants with Reduction in Stool Frequency Score of >= 1 From Baseline
Time frame: Up to Week 8
Change from Baseline in Calculated Partial Mayo Score at Week 8 and Week 16 or Week 20
Time frame: Baseline, Week 8 and Week 16 or Week 20
Change from Baseline in Rectal Bleeding Score at Week 16 or Week 20
Time frame: Baseline, Week 16 or Week 20
Change from Baseline in Stool Frequency Score at Week 16 or Week 20
Time frame: Baseline, Week 16 or Week 20
Change from Baseline in Abdominal Pain Through Week 8
Time frame: Baseline, Up to Week 8
Percentage of Participants with Presence of Nocturnal Diarrhea
Time frame: Up to Week 8
Percentage of Participants with Presence of Tenesmus
Time frame: Up to Week 8
Percentage of Participants with Perceived Improvement in Ulcerative Colitis (UC)
Time frame: Up to Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2025.
- Derived from this study: PubMed 42766096Nagano K, Emoto S, Nishimura Y, Sugi M, Amano M, Yoshigoe S, Nishimura K, Matsuoka K. Using Pre-Study Patient Interviews to Refine Electronic Patient-Reported Outcomes in Clinical Research of Ustekinumab Induction for Ulcerative Colitis (SIRIUS Study). Adv Ther. 2026 Sep 21. doi: 10.1007/s12325-026-03770-6. Online ahead of print.
- Derived from this study: PubMed 35508346Matsuoka 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Pharmaceutical K.K., Japan Clinical Trial study director
Janssen Pharmaceutical K.K.
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis, run by Janssen Pharmaceutical K.K. at 23 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With a Rectal Bleeding Score of 0 or 1 (time frame: Up to Week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04963725, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2025.