Actively Recruiting
Study to Assess Change in Disease Activity of Risankizumab Treatment in Japanese Participants With Moderate to Severe Ulcerative Colitis
Led by AbbVie · Updated on 2026-04-13
200
Participants Needed
28
Research Sites
225 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study to Assess Change in Disease Activity of Risankizumab Treatment in Japanese Participants With Moderate to Severe Ulcerative Colitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of moderate to severe Ulcerative Colitis
- Started risankizumab treatment prescribed as routine care under Japan approved label
- Prescription decision made before and independently of study participation
- Able to provide voluntary informed consent (or parent/legal guardian consent if under 18)
- Able to understand, communicate, and comply with study requirements including use of a smart device for data collection
- No prior exposure to risankizumab
- Not currently participating in interventional research (excluding non-interventional studies, PMOS, or registries)
You will not qualify if you...
- See Inclusion Criteria
AI-Screening
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Trial Site Locations
Total: 28 locations
1
Aichi Medical University Hospital /ID# 278155
Nagakute, Aichi-ken, Japan, 480-1195
Actively Recruiting
2
Nagoya University Hospital /ID# 278159
Nagoya, Aichi-ken, Japan, 466-8560
Actively Recruiting
3
Hirosaki University Hospital /ID# 278153
Hirosaki, Aomori, Japan, 036-8563
Actively Recruiting
4
Chiba University Hospital /ID# 277669
Chiba, Chiba, Japan, 260-8677
Actively Recruiting
5
Tsujinaka Hospital - Kashiwanoha /ID# 277672
Kashiwa-shi, Chiba, Japan, 277-0871
Actively Recruiting
6
Toho University Sakura Medical Center /ID# 277536
Sakura, Chiba, Japan, 285-0841
Actively Recruiting
7
Kyushu University Hospital /ID# 278077
Fukuoka, Fukuoka, Japan, 812-8582
Actively Recruiting
8
Sapporo Medical University Hospital /ID# 277535
Sapporo, Hokkaido, Japan, 060-8543
Actively Recruiting
9
Hokkaido University Hospital /ID# 277668
Sapporo, Hokkaido, Japan, 060-8648
Actively Recruiting
10
Sapporo Higashi Tokushukai Hospital /ID# 278123
Sapporo, Hokkaido, Japan, 065-0033
Actively Recruiting
11
Kobe University Hospital /ID# 278292
Kobe, Hyōgo, Japan, 650-0017
Actively Recruiting
12
Hyogo Medical University Hospital /ID# 277676
Nishinomiya-shi, Hyōgo, Japan, 663-8501
Actively Recruiting
13
University Hospital Kyoto Prefectural University of Medicine /ID# 277541
Kyoto, Kyoto, Japan, 602-8566
Actively Recruiting
14
Kansai Medical University Hospital /ID# 278619
Hirakata-shi, Osaka, Japan, 573-1191
Actively Recruiting
15
Saga University Hospital /ID# 278160
Saga, Saga-ken, Japan, 849-8501
Actively Recruiting
16
Saitama Medical Center /ID# 278076
Kawagoe, Saitama, Japan, 350-8550
Actively Recruiting
17
Shiga University of Medical Science Hospital /ID# 277540
Ōtsu, Shiga, Japan, 520-2192
Actively Recruiting
18
Hamamatsu University Hospital /ID# 277539
Hamamatsu, Shizuoka, Japan, 431-3192
Actively Recruiting
19
NHO Shizuoka Medical Center /ID# 278075
Sunto-gun, Shizuoka, Japan, 411-8611
Actively Recruiting
20
Dokkyo Medical University Hospital /ID# 278152
Mibu, Tochigi, Japan, 321-0293
Actively Recruiting
21
Institute of Science Tokyo Hospital /ID# 277538
Bunkyo-ku, Tokyo, Japan, 113-8519
Actively Recruiting
22
Kitasato University Kitasato Institute Hospital /ID# 278154
Minato-ku, Tokyo, Japan, 108-8642
Actively Recruiting
23
Kyorin University Hospital /ID# 277534
Mitaka-shi, Tokyo, Japan, 181-8611
Actively Recruiting
24
Fukuoka University Hospital /ID# 277677
Fukuoka, Japan, 814-0180
Actively Recruiting
25
Hiroshima University Hospital /ID# 277542
Hiroshima, Japan, 734-8551
Not Yet Recruiting
26
Sapporo Kosei General Hospital /ID# 278048
Sapporo, Japan, 060-0033
Actively Recruiting
27
The Jikei University Hospital /ID# 278122
Tokyo, Japan, 105-8461
Actively Recruiting
28
Toyama University Hospital /ID# 277675
Toyama, Japan, 930-0194
Actively Recruiting
Research Team
A
AbbVie GK Clinical Trial Registration Desk
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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