An Observational Study to Assess Change in Disease Activity and Adverse Events of Rinvoq in Adult Participants With Moderate to Severe Ulcerative Colitis (UC) in Japan

NCT05791526 | Completed

• 1 other identifier: P22-962
• Study Type: observational
• Target: 308
• Locations: 1 country
• Sites: 114

Brief Summary

Ulcerative colitis (UC) is an idiopathic, chronic, inflammatory disease affecting the colon. Participants with UC have mucosal inflammation starting in the rectum that can extend continuously to proximal segments of the colon. This study will assess how safe and effective Rinvoq is in treating adult participants with moderate to severe ulcerative colitis (UC). Adverse events and change in disease activity will be assessed. Rinvoq is a drug approved for the treatment of ulcerative colitis (UC). All study participants will receive Rinvoq as prescribed by their study doctor in accordance with approved local label. Approximately 300 adult participants will be enrolled in Japan. Participants will receive upadacitinib as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 60 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

Ulcerative Colitis

Keywords

Ulcerative colitis; UC; Rinvoq; Upadacitinib

Outcome Measures

Primary Outcomes (1)

• Incidence Percentage of Serious Infection Reported as Adverse Drug Reaction (ADR)

  An Adverse Event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with their treatment. Among AEs, an event whose causal relationship with the product cannot be ruled out is considered an adverse drug reaction.

  Up to 60 weeks

Study Arms (1)

Participants Receiving Upadacitinib

Participants receiving upadacitinib for moderate to severe Ulcerative colitis (UC) in real-world practice.

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants with moderately to severely active Ulcerative colitis (UC)

You may qualify if:

• Participants diagnosed with moderately to severely active Ulcerative colitis (UC).
• Participants who are within 14 days from the commencement of Rinvoq treatment for UC.
• Participants who are administered the first dose of Rinvoq for UC after approval for UC in Japan.

You may not qualify if:

• Participants currently participating in registrational clinical trial.
• Participants for whom Rinvoq is contraindicated.
• Participants that have been previously exposed to Rinvoq.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (114)

Anjou Kousei Hospital /ID# 256207

Anjo-shi, Aichi-ken, 446-8602, Japan

Location

Ichinomiyanishi Hospital /ID# 259498

Ichinomiya-shi, Aichi-ken, 494-0001, Japan

Location

Aikawa Minnano-shinryojo /ID# 258447

Nagoya, Aichi-ken, 458-0011, Japan

Location

Shimozato Clinic /ID# 261901

Nagoya, Aichi-ken, 458-0044, Japan

Location

Miwa Internist and Gastroenterology Clinic Aoi /ID# 267049

Nagoya, Aichi-ken, 461-0004, Japan

Location

Yamada Coloproctology Clinic /ID# 259508

Niwa-gun, Aichi-ken, 480-0147, Japan

Location

Toyohashi Municipal Hospital /ID# 267048

Toyohashi, Aichi-ken, 441-8570, Japan

Location

Ieda Hospital /ID# 257012

Toyota-shi, Aichi-ken, 470-1219, Japan

Location

Hachinohe City Hospital /ID# 256198

Hachinohe-shi, Aomori, 031-8555, Japan

Location

Asahi General Hospital /ID# 258446

Asahi, Chiba, 289-2511, Japan

Location

Chiba Clinic /ID# 257015

Chiba, Chiba, 260-0018, Japan

Location

Nippon Medical Chiba Hokusoh Hospital /ID# 259505

Inzai-shi, Chiba, 270-1613, Japan

Location

Tsujinaka Hospital - Kashiwanoha /ID# 257013

Kashiwa-shi, Chiba, 277-0871, Japan

Location

Juntendo University Urayasu Hospital /ID# 265635

Urayasu, Chiba, 279-0021, Japan

Location

Matsuyama Red Cross Hospital /ID# 260211

Matsuyama, Ehime, 790-8524, Japan

Location

Kobayashi Clinic /ID# 265631

Chikugo-shi, Fukuoka, 833-0005, Japan

Location

Fukuoka University Chikushi Hospital /ID# 255248

Chikushino-shi, Fukuoka, 818-8502, Japan

Location

Sakemi clinic /ID# 261889

Fukuoka, Fukuoka, 813-0003, Japan

Location

Tobata Kyoritsu Hospital /ID# 257043

Kitakyusyu-shi, Fukuoka, 803-0836, Japan

Location

Hidaka Clinic of Coloproctology /ID# 252879

Kurume-shi, Fukuoka, 839-0809, Japan

Location

Hoshi General Hospital /ID# 261292

Koriyama-shi, Fukushima, 963-8501, Japan

Location

Southern Tohoku General Hospital /ID# 267043

Kōriyama, Fukushima, 963-8563, Japan

Location

Fukutomi Icyo Clinic /ID# 267047

Gifu, Gifu, 500-8175, Japan

Location

Gifu Municipal Hospital /ID# 255254

Gifu, Gifu, 500-8323, Japan

Location

Gifu University Hospital /ID# 258435

Gifu, Gifu, 501-1194, Japan

Location

Mori Surgical Clinic /ID# 258445

Ogaki-shi, Gifu, 503-0031, Japan

Location

Chuno Kosei Hospital /ID# 263042

Seki-shi, Gifu, 501-3802, Japan

Location

Gifu Prefectural Tajimi Hosp /ID# 260213

Tajimi-shi, Gifu, 507-8522, Japan

Location

Kudo Gastroenterology Clinic /ID# 255251

Takasaki-shi, Gunma, 370-0848, Japan

Location

National Hospital Organization Fukuyama Medical Center /ID# 255246

Fukuyama-shi, Hiroshima, 720-8520, Japan

Location

Kaisei Clinic /ID# 258441

Hiroshima, Hiroshima, 730-0017, Japan

Location

Hiroshima University Hospital /ID# 257045

Hiroshima, Hiroshima, 734-8551, Japan

Location

Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 258437

Sapporo, Hokkaido, 060-0033, Japan

Location

Sapporo IBD Clinic /ID# 255255

Sapporo, Hokkaido, 064-0919, Japan

Location

Kobe University Hospital /ID# 260212

Kobe, Hyōgo, 650-0017, Japan

Location

Nishi-Kobe Medical Center /ID# 258433

Kobe, Hyōgo, 651-2273, Japan

Location

Hida Endoscopy Clinic /ID# 255252

Nishinomiya-shi, Hyōgo, 662-0973, Japan

Location

Hyogo Medical University Hospital /ID# 259500

Nishinomiya-shi, Hyōgo, 663-8501, Japan

Location

Hitachinaka General Hospital /ID# 256209

Hitachi-Naka, Ibaraki, 312-0057, Japan

Location

Tokyo Medical University Ibaraki Medical Center /ID# 260210

Inashiki-shi, Ibaraki, 300-0332, Japan

Location

Koyama Memorial Hospital /ID# 256212

Kashima-shi, Ibaraki, 314-0030, Japan

Location

Tsuchiura Kyodo General Hospital /ID# 260732

Tsuchiura-shi, Ibaraki, 300-0053, Japan

Location

Kanazawa Red Cross Hospital /ID# 262653

Kanazawa, Ishikawa-ken, 921-8162, Japan

Location

Takamatsu Red Cross Hospital /ID# 259493

Takamatsu, Kagawa-ken, 760-0017, Japan

Location

Sameshima Hospital /ID# 256215

Kagoshima, Kagoshima-ken, 892-0846, Japan

Location

Kagoshima IBD Gastroenterology Clinic /ID# 255191

Kagoshima, Kagoshima-ken, 8920804, Japan

Location

Atsugi Familly Clinic /ID# 259496

Atsugi-shi, Kanagawa, 243-0018, Japan

Location

Gokeikai Ofuna Chuo Hospital /ID# 259502

Kamakura-shi, Kanagawa, 247-0056, Japan

Location

Shin-Yurigaoka General Hospital /ID# 265634

Kawasaki-shi, Kanagawa, 215-0026, Japan

Location

Kitasato University Hospital /ID# 267442

Sagamihara-shi, Kanagawa, 252-0375, Japan

Location

Yokohama Municipal Citizen's Hospital /ID# 259503

Yokohama, Kanagawa, 221-0855, Japan

Location

Saiseikai Yokohamashi Tobu /ID# 261896

Yokohama, Kanagawa, 230-0012, Japan

Location

Koganecho Sukoyaka Clinic /ID# 257014

Yokohama, Kanagawa, 232-0003, Japan

Location

Yokohama Totsukaekimae Clinic /ID# 259509

Yokohama, Kanagawa, 244-0003, Japan

Location

Coloproctology Center Takano Hospital /ID# 257041

Kumamoto, Kumamoto, 862-0971, Japan

Location

Japanese Red Cross Kyoto Daiichi Hosital /ID# 256213

Kyoto, Kyoto, 605-0981, Japan

Location

National Hospital Organization Kyoto Medical Center /ID# 259497

Kyoto, Kyoto, 612-8555, Japan

Location

Mie University Hospital /ID# 257011

Tsu, Mie-ken, 514-8507, Japan

Location

Yokkaichi Hazu Medical Center /ID# 257010

Yokkaichi-shi, Mie-ken, 510-0016, Japan

Location

Tohoku Medical and Pharmaceutical University Hospital /ID# 265636

Sendai, Miyagi, 983-8512, Japan

Location

Showa Inan General Hospital /ID# 258413

Komagane-shi, Nagano, 3994117, Japan

Location

Shinonoi General Hospital /ID# 261893

Nagano, Nagano, 388-8004, Japan

Location

Nara Prefecture General Medical Center - Nara /ID# 256211

Nara, Nara, 630-8581, Japan

Location

Nagaoka Red Cross Hospital /ID# 255250

Nagaoka-shi, Niigata, 940-2085, Japan

Location

Yoneyama Clinic /ID# 256210

Niigata, Niigata, 950-2028, Japan

Location

Ishida Clinic of IBD and Gastroenterology /ID# 252878

Ōita, Oita Prefecture, 870-0823, Japan

Location

Okayama University Hospital /ID# 262651

Okayama, Okayama-ken, 700-8558, Japan

Location

University of the Ryukyus Hospital /ID# 257044

Ginowan-shi, Okinawa, 901-2725, Japan

Location

Naha City Hospital /ID# 255249

Naha, Okinawa, 902-0061, Japan

Location

Nakagami Hospital /ID# 256214

Okinawa-shi, Okinawa, 904-2195, Japan

Location

Urasoe General Hospital /ID# 267042

Urasoe, Okinawa, 901-2132, Japan

Location

Sai Gastroenterology and Proctology Clinic /ID# 252880

Fujidera-shi, Osaka, 583-0027, Japan

Location

Hirakata Kohsai Hospital /ID# 256216

Hirakata, Osaka, 573-0153, Japan

Location

Kansai Medical University Hospital /ID# 255247

Hirakata-shi, Osaka, 573-1191, Japan

Location

Kinshukai Infusion Clinic /ID# 253199

Osaka, Osaka, 530-0011, Japan

Location

National Hospital Organization Osaka National Hospital /ID# 257042

Osaka, Osaka, 540-0006, Japan

Location

Osaka Metropolitan University Hospital /ID# 258319

Osaka, Osaka, 545-8586, Japan

Location

Tane General Hospital /ID# 259495

Osaka, Osaka, 550-0025, Japan

Location

Yoshino Medical Clinic /ID# 255192

Osaka, Osaka, 553-0002, Japan

Location

Osaka Rosai Hospital /ID# 255244

Sakai-shi, Osaka, 591-8025, Japan

Location

Toyonaka Municipal Hospital /ID# 258414

Toyonaka-shi, Osaka, 560-0055, Japan

Location

Ohmori Toshihide gastro-intestinal Clinic /ID# 256205

Ageo-shi, Saitama, 362-0075, Japan

Location

Kumagaya General Hospital /ID# 261294

Kumagaya-shi, Saitama, 331-0074, Japan

Location

Shiga University of Medical Science Hospital /ID# 258323

Ōtsu, Shiga, 520-2192, Japan

Location

Hamamatsu University Hospital /ID# 258438

Hamamatsu, Shizuoka, 431-3192, Japan

Location

Kato Clinic /ID# 254489

Hamamatsu, Shizuoka, 432-8061, Japan

Location

Kashiwabara Gastroenterology Clinic /ID# 261885

Hamamatsu, Shizuoka, 433-8113, Japan

Location

Shizuoka Aoi Clinic /ID# 260219

Shizuoka, Shizuoka, 420-0881, Japan

Location

NHO Shizuoka Medical Center /ID# 260214

Sunto-gun, Shizuoka, 411-8611, Japan

Location

Dokkyo Medical University Hospital /ID# 257040

Mibu, Tochigi, 321-0293, Japan

Location

Saiseikai Utsunomiya Hospital /ID# 254488

Utsunomiya, Tochigi, 321-0974, Japan

Location

Juntendo University Hospital /ID# 259504

Bunkyo-ku, Tokyo, 113-8431, Japan

Location

Ginza Central Clinic /ID# 256208

Chuo-ku, Tokyo, 104-0061, Japan

Location

Koganei Tsurukame Clinic /ID# 260215

Koganei-shi, Tokyo, 184-0004, Japan

Location

Kitasato University Kitasato Institute Hospital /ID# 258434

Minato-ku, Tokyo, 108-8642, Japan

Location

Kyorin University Hospital /ID# 261293

Mitaka-shi, Tokyo, 181-8611, Japan

Location

Ohori IBD Clinic /ID# 255253

Setagaya-ku, Tokyo, 155-0032, Japan

Location

Shinjuku Tsurukame Clinic /ID# 258443

Shibuya-ku, Tokyo, 151-0053, Japan

Location

Showa University Hospital /ID# 261898

Shinagawa-ku, Tokyo, 142-8666, Japan

Location

Tokyo Medical University Hospital /ID# 261291

Shinjuku-ku, Tokyo, 160-0023, Japan

Location

Keio University Hospital /ID# 261899

Shinjuku-ku, Tokyo, 160-8582, Japan

Location

Tokyo Women's Medical University Hospital /ID# 261887

Shinjuku-ku, Tokyo, 162-8666, Japan

Location

Japan Community Health care Organization Tokyo Yamate Medical Center /ID# 261886

Shinjuku-ku, Tokyo, 169-0073, Japan

Location

Tottori University Hospital /ID# 265633

Yonago, Tottori, 683-8504, Japan

Location

Yokota Memorial Hospital /ID# 267044

Toyama, Toyama, 939-8085, Japan

Location

Japanese Red Cross Wakayama Medical Center /ID# 255245

Wakayama, Wakayama, 640-8558, Japan

Location

Wakayama Medical University Hospital /ID# 259506

Wakayama, Wakayama, 641-8510, Japan

Location

Yamaguchi Red Cross Hospital /ID# 257016

Yamaguchi, Yamaguchi, 753-8519, Japan

Location

Iwamoto Naika Onaka Clinic /ID# 261888

Kofu, Yamanashi, 400-0813, Japan

Location

Aomori Prefectural Central Hospital /ID# 266719

Aomori, 030-0913, Japan

Location

Hattori Clinic - Kumamoto /ID# 263978

Kumamoto, 860-0004, Japan

Location

Nagasaki Harbor Medical Center /ID# 264425

Nagasaki, 850-0842, Japan

Location

St. Luke's International Hospital /ID# 264301

Tokyo, 104-8560, Japan

Location

The Jikei University Hospital /ID# 262652

Tokyo, 105-8461, Japan

Location

Related Links

• Related info

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2023
• First Posted: March 30, 2023
• Study Start: December 19, 2022
• Primary Completion: December 9, 2025
• Study Completion: December 9, 2025
• Last Updated: December 31, 2025

Record last verified: 2025-12

Locations

JP (114)