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Taking people in JapanNo phase

Tracks disease activity in Japanese adults on risankizumab for ulcerative colitis

Observes how moderate to severe ulcerative colitis changes in people treated with risankizumab.

Plain-language title generated from the registry record
Registry title: Study to Assess Change in Disease Activity of Risankizumab Treatment in Japanese Participants With Moderate to Severe Ulcerative Colitis

Key facts

Where
Bunkyo-ku, Chiba, Fukuoka, Hamamatsu, Hirakata-shi, Hirosaki, Hiroshima, Kashiwa-shi, Kawagoe, Kobe, Kyoto, Mibu, Minato-ku, Mitaka-shi, Nagakute, Nagoya, Nishinomiya-shi, Okayama, Ōtsu, Saga, Sakura, Sapporo, Sunto-gun, Tokyo, and Toyama, JapanSee the 29 sites

Where in Japan

  • Institute of Science Tokyo Hospital /ID# 277538Bunkyo-ku, JapanTaking people
  • Chiba University Hospital /ID# 277669Chiba, JapanTaking people
  • Fukuoka University Hospital /ID# 277677Fukuoka, JapanTaking people
  • Kyushu University Hospital /ID# 278077Fukuoka, JapanTaking people
  • Hamamatsu University Hospital /ID# 277539Hamamatsu, JapanTaking people
  • Kansai Medical University Hospital /ID# 278619Hirakata-shi, JapanTaking people
  • Hirosaki University Hospital /ID# 278153Hirosaki, JapanTaking people
  • Hiroshima University Hospital /ID# 277542Hiroshima, JapanTaking people
  • Tsujinaka Hospital - Kashiwanoha /ID# 277672Kashiwa-shi, JapanTaking people
  • Saitama Medical Center /ID# 278076Kawagoe, JapanTaking people
  • Kobe University Hospital /ID# 278292Kobe, JapanTaking people
  • University Hospital Kyoto Prefectural University of Medicine /ID# 277541Kyoto, JapanTaking people
  • Dokkyo Medical University Hospital /ID# 278152Mibu, JapanTaking people
  • Kitasato University Kitasato Institute Hospital /ID# 278154Minato-ku, JapanTaking people
  • Kyorin University Hospital /ID# 277534Mitaka-shi, JapanTaking people
  • Aichi Medical University Hospital /ID# 278155Nagakute, JapanTaking people
  • Nagoya University Hospital /ID# 278159Nagoya, JapanTaking people
  • Hyogo Medical University Hospital /ID# 277676Nishinomiya-shi, JapanTaking people
  • Okayama University Hospital /ID# 281615Okayama, JapanTaking people
  • Shiga University of Medical Science Hospital /ID# 277540Ōtsu, JapanTaking people
  • Saga University Hospital /ID# 278160Saga, JapanTaking people
  • Toho University Sakura Medical Center /ID# 277536Sakura, JapanTaking people
  • Hokkaido University Hospital /ID# 277668Sapporo, JapanTaking people
  • Sapporo Higashi Tokushukai Hospital /ID# 278123Sapporo, JapanTaking people
  • Sapporo Kosei General Hospital /ID# 278048Sapporo, JapanTaking people
  • Sapporo Medical University Hospital /ID# 277535Sapporo, JapanTaking people
  • NHO Shizuoka Medical Center /ID# 278075Sunto-gun, JapanTaking people
  • The Jikei University Hospital /ID# 278122Tokyo, JapanTaking people
  • Toyama University Hospital /ID# 277675Toyama, JapanTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
AbbVie
Trial code
NCT07136116
Record updated
14 August 2026
Original description
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.Read full original descriptionShow less

A Prospective, Real-World Study Evaluating the Impact of RISankizumab on BurdEn of Disease in Ulcerative Colitis in JaPan (RISE UP)

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.

Inclusion: Participants with a diagnosis of moderate to severe Ulcerative Colitis (UC) commenced on Risankizumab (RZB) treatment prescribed as part of their routine clinical care at their clinical's discretion according to Japan approved label and treatment prescription recommendations/guidelines; The decision to prescribe RZB is made prior to and independently of study participation; Participants able to provide voluntary informed consent before any study-related activities or procedures (obtained/documented as per regulations). If the patient is under 18 years old, a patient's parent or legal guardian must be willing to give written informed consent; Participants who can understand and communicate with the investigator and comply with the requirements of the study, including collection of PRO data using a smart device (i.e., mobile phone) and continued PRO data collection after cessation of RZB; Participants without previous exposure to RZB; Participants who are not currently participating in interventional research (not including non-interventional studies, PMOS, or registry participation).

Exclusion: See Inclusion Criteria.

ClinicalTrials.gov NCT07136116