Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). This study will assess the change in disease activity of risankizumab treatment in adult participants with moderate to severe UC in real-world clinical practice.
Risankizumab is an approved drug for treating participants with ulcerative colitis. Approximately 200 participants who are prescribed risankizumab by their physician in accordance with local label will be enrolled in approximately 30 sites across Japan.
Participants will receive risankizumab as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 156 weeks.
There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Risankizumab | Participants will receive risankizumab as prescribed by their physician according to local label. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| To assess the achievement of clinical remission per Partial Adapted Mayo Score of Risankizumab treatment in participants with moderate to severe Ulcerative Colitis (UC) | Defined as stool frequency subscore [SFS] ≤1 and rectal bleeding subscore [RBS]=0 | At Week 52 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
See Inclusion Criteria
Not provided
Not provided
Not provided
The study population will include adult participants with moderate to severe UC who are being treated with RZB according to the relevant approved license and who are eligible according to the study eligibility criteria.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AbbVie GK Clinical Trial Registration Desk | Contact | +81-3-4577-1111 | abbvie_jpn_info_clingov@abbvie.com |
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aichi Medical University Hospital /ID# 278155 | Recruiting | Nagakute | Aichi-ken | 480-1195 | Japan | |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Nagoya University Hospital /ID# 278159 |
| Recruiting |
| Nagoya |
| Aichi-ken |
| 466-8560 |
| Japan |
| Hirosaki University Hospital /ID# 278153 | Recruiting | Hirosaki | Aomori | 036-8563 | Japan |
| Chiba University Hospital /ID# 277669 | Recruiting | Chiba | Chiba | 260-8677 | Japan |
| Tsujinaka Hospital - Kashiwanoha /ID# 277672 | Recruiting | Kashiwa-shi | Chiba | 277-0871 | Japan |
| Toho University Sakura Medical Center /ID# 277536 | Recruiting | Sakura | Chiba | 285-0841 | Japan |
| Kyushu University Hospital /ID# 278077 | Recruiting | Fukuoka | Fukuoka | 812-8582 | Japan |
| Sapporo Medical University Hospital /ID# 277535 | Recruiting | Sapporo | Hokkaido | 060-8543 | Japan |
| Hokkaido University Hospital /ID# 277668 | Recruiting | Sapporo | Hokkaido | 060-8648 | Japan |
| Sapporo Higashi Tokushukai Hospital /ID# 278123 | Recruiting | Sapporo | Hokkaido | 065-0033 | Japan |
| Kobe University Hospital /ID# 278292 | Recruiting | Kobe | Hyōgo | 650-0017 | Japan |
| Hyogo Medical University Hospital /ID# 277676 | Recruiting | Nishinomiya-shi | Hyōgo | 663-8501 | Japan |
| University Hospital Kyoto Prefectural University of Medicine /ID# 277541 | Recruiting | Kyoto | Kyoto | 602-8566 | Japan |
| Kansai Medical University Hospital /ID# 278619 | Recruiting | Hirakata-shi | Osaka | 573-1191 | Japan |
| Saga University Hospital /ID# 278160 | Recruiting | Saga | Saga-ken | 849-8501 | Japan |
| Saitama Medical Center /ID# 278076 | Recruiting | Kawagoe | Saitama | 350-8550 | Japan |
| Shiga University of Medical Science Hospital /ID# 277540 | Recruiting | Ōtsu | Shiga | 520-2192 | Japan |
| Hamamatsu University Hospital /ID# 277539 | Recruiting | Hamamatsu | Shizuoka | 431-3192 | Japan |
| NHO Shizuoka Medical Center /ID# 278075 | Recruiting | Sunto-gun | Shizuoka | 411-8611 | Japan |
| Dokkyo Medical University Hospital /ID# 278152 | Recruiting | Mibu | Tochigi | 321-0293 | Japan |
| Institute of Science Tokyo Hospital /ID# 277538 | Recruiting | Bunkyo-ku | Tokyo | 113-8519 | Japan |
| Kitasato University Kitasato Institute Hospital /ID# 278154 | Recruiting | Minato-ku | Tokyo | 108-8642 | Japan |
| Kyorin University Hospital /ID# 277534 | Recruiting | Mitaka-shi | Tokyo | 181-8611 | Japan |
| Fukuoka University Hospital /ID# 277677 | Recruiting | Fukuoka | 814-0180 | Japan |
| Hiroshima University Hospital /ID# 277542 | Not yet recruiting | Hiroshima | 734-8551 | Japan |
| Sapporo Kosei General Hospital /ID# 278048 | Recruiting | Sapporo | 060-0033 | Japan |
| The Jikei University Hospital /ID# 278122 | Recruiting | Tokyo | 105-8461 | Japan |
| Toyama University Hospital /ID# 277675 | Recruiting | Toyama | 930-0194 | 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 |
Not provided
Not provided