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| ID | Type | Description | Link |
|---|---|---|---|
| CNTO1275UCO4004 | Other Identifier | Janssen Pharmaceutical K.K., Japan |
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The purpose of this study is to describe the initial response to ustekinumab induction treatment for ulcerative colitis (UC) in Japan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Pharmaceutical K.K., Japan Clinical Trial | Janssen Pharmaceutical K.K. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tokyo Medical and Dental University Hospital | Bunkyō City | 113 8519 | Japan | |||
| Juntendo University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35508346 | Derived | 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. |
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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 |
| Bunkyō City |
| 113-8431 |
| Japan |
| Chiba University Hospital | Chiba | 260 8677 | Japan |
| Toho University Sakura Medical Center | Chiba | 285-8741 | Japan |
| Kyushu University Hospital | Fukuoka | 812 8582 | Japan |
| Fukuoka University Hospital | Fukuoka | 814-0180 | Japan |
| Hamamatsu University Hospital | Hamamatsu | 431 3192 | Japan |
| Shimane University Hospital | Izumo | 693-8501 | Japan |
| Tsujinaka Hospital Kashiwanoha | Kashiwa | 277-0871 | Japan |
| Saitama Medical University Saitama Medical Center | Kawagoe | 350-8550 | Japan |
| University Hospital Kyoto Prefectural University of Medicine | Kyoto | 602-8566 | Japan |
| Kitasato University Kitasato Institute Hospital | Minatoku | 108-8642 | Japan |
| Kyorin University Hospital | Mitaka | 181-8611 | Japan |
| Nagoya University Hospital | Nagoya | 466 8560 | Japan |
| Okayama University Hospital | Okayama | 700 8558 | Japan |
| Ishida Clinic of IBD and Gastroenterology | Ōita | 870-0823 | Japan |
| Shiga University of Medical Science Hospital | Ōtsu | 520-2192 | Japan |
| Sapporo Medical University Hospital | Sapporo | 060-8543 | Japan |
| Tohoku University Hospital | Sendai | 980 8574 | Japan |
| Tokyo Yamate Medical Center | Shinjuku-ku | 169-0073 | Japan |
| Osaka Medical and Pharmaceutical University Hospital | Takatsuki | 569-8686 | Japan |
| Toyama Prefectural Central Hospital | Toyama | 930 8550 | Japan |
| Yokkaichi Hazu Medical Center | Yokkaichi | 510-0016 | Japan |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D000069549 | Ustekinumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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