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

April 25, 2024 updated by: AbbVie

A Prospective Observational Study for Evaluation of Safety and Effectiveness of Rinvoq in Moderately to Severely Active Ulcerative Colitis; a Japanese Post-Marketing Study

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
      • Hachinohe-shi, Japan, 031-8555
        • Recruiting
        • Hachinohe City Hospital /ID# 256198
      • Kumamoto, Japan, 860-0004
        • Recruiting
        • Hattori Clinic /ID# 263978
      • Mitaka, Japan, 181-8611
        • Recruiting
        • Kyorin University - Mitaka Campus /ID# 261293
      • Nagasaki, Japan, 850-0842
        • Recruiting
        • Nagasaki Harbor Medical Center /ID# 264425
      • Okayama, Japan, 700-8558
        • Recruiting
        • Okayama University Hospital /ID# 262651
      • Tokyo, Japan, 104-8560
        • Recruiting
        • St. Luke's International Hospital /ID# 264301
    • Aichi
      • Anjo-shi, Aichi, Japan, 446-8602
        • Recruiting
        • Anjou Kousei Hospital /ID# 256207
      • Ichinomiya-shi, Aichi, Japan, 494-0001
        • Recruiting
        • Ichinomiyanishi Hospital /ID# 259498
      • Nagoya-shi, Aichi, Japan, 458-0011
        • Recruiting
        • Aikawa Minnano-shinryojo /ID# 258447
      • Nagoya-shi, Aichi, Japan, 458-0044
        • Recruiting
        • Shimozato Clinic /ID# 261901
      • Nagoya-shi, Aichi, Japan, 461-0004
        • Recruiting
        • Miwa Internist and Gastroenterology Clinic Aoi /ID# 267049
      • Niwa-gun, Aichi, Japan, 480-0147
        • Recruiting
        • Yamada Coloproctology Clinic /ID# 259508
      • Toyota-shi, Aichi, Japan, 470-1219
        • Recruiting
        • Ieda Hospital /ID# 257012
    • Chiba
      • Asahi-shi, Chiba, Japan, 289-2511
        • Recruiting
        • Asahi General Hospital /ID# 258446
      • Chiba-shi, Chiba, Japan, 260-0018
        • Recruiting
        • Chiba Clinic /ID# 257015
      • Inzai-shi, Chiba, Japan, 270-1613
        • Recruiting
        • Nippon Medical Chiba Hokusoh Hospital /ID# 259505
      • Kashiwa-shi, Chiba, Japan, 277-0871
        • Recruiting
        • Tsujinaka Hospital Kashiwanoha /ID# 257013
      • Urayasu, Chiba, Japan, 279-0021
        • Recruiting
        • Juntendo University Urayasu Hospital /ID# 265635
    • Ehime
      • Matsuyama-shi, Ehime, Japan, 790-8524
        • Recruiting
        • Matsuyama Red Cross Hospital /ID# 260211
    • Fukuoka
      • Chikugo-shi, Fukuoka, Japan, 833-0005
        • Recruiting
        • Kobayashi Clinic /ID# 265631
      • Chikushino-shi, Fukuoka, Japan, 818-8502
        • Recruiting
        • Fukuoka University Chikushi Hospital /ID# 255248
      • Fukuoka-shi, Fukuoka, Japan, 813-0003
        • Recruiting
        • Sakemi clinic /ID# 261889
      • Kitakyusyu-shi, Fukuoka, Japan, 803-0836
        • Recruiting
        • Tobata Kyoritsu Hospital /ID# 257043
      • Kurume-shi, Fukuoka, Japan, 839-0809
        • Recruiting
        • Hidaka Clinic of Coloproctology /ID# 252879
    • Fukushima
      • Koriyama City, Fukushima, Japan, 963-8801
        • Recruiting
        • Hoshi General Hospital /ID# 261292
    • Gifu
      • Gifu-shi, Gifu, Japan, 500-8513
        • Recruiting
        • Gifu Municipal Hospital /ID# 255254
      • Gifu-shi, Gifu, Japan, 501-1194
        • Recruiting
        • Gifu University Hospital /ID# 258435
      • Ogaki-shi, Gifu, Japan, 503-0031
        • Recruiting
        • Mori Surgical Clinic /ID# 258445
      • Seki City, Gifu, Japan, 501-3802
        • Recruiting
        • Chuno Kosei Hospital /ID# 263042
      • Tajimi-shi, Gifu, Japan, 507-8522
        • Recruiting
        • Gifu Prefectural Tajimi Hosp /ID# 260213
    • Gunma
      • Takasaki-shi, Gunma, Japan, 370-0848
        • Recruiting
        • Kudo Gastroenterology Clinic /ID# 255251
    • Hiroshima
      • Fukuyama-shi, Hiroshima, Japan, 720-8520
        • Recruiting
        • NHO Fukuyama Medical Center /ID# 255246
      • Hiroshima-shi, Hiroshima, Japan, 734-8551
        • Recruiting
        • Hiroshima University Hospital /ID# 257045
      • Hiroshima-shi, Hiroshima, Japan, 730-0017
        • Recruiting
        • Kaisei Clinic /ID# 258441
    • Hokkaido
      • Sapporo-shi, Hokkaido, Japan, 064-0919
        • Recruiting
        • Sapporo IBD Clinic /ID# 255255
      • Sapporo-shi, Hokkaido, Japan, 060-0033
        • Recruiting
        • Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 258437
    • Hyogo
      • Kobe-shi, Hyogo, Japan, 651-2273
        • Recruiting
        • Nishi-Kobe Medical Center /ID# 258433
      • Kobe-shi, Hyogo, Japan, 650-0017
        • Recruiting
        • Kobe University Hospital /ID# 260212
      • Nishinomiya-shi, Hyogo, Japan, 662-0973
        • Recruiting
        • Hida Endoscopy Clinic /ID# 255252
      • Nishinomiya-shi, Hyogo, Japan, 663-8501
        • Recruiting
        • Hyogo Medical University Hospital /ID# 259500
    • Ibaraki
      • Hitachinaka-shi, Ibaraki, Japan, 312-0057
        • Recruiting
        • Hitachinaka General Hospital /ID# 256209
      • Inashiki-shi, Ibaraki, Japan, 300-0332
        • Recruiting
        • Tokyo Medical University Ibaraki Medical Center /ID# 260210
      • Kashima City, Ibaraki, Japan, 314-0030
        • Recruiting
        • Koyama Memorial Hospital /ID# 256212
      • Tsuchiura-shi, Ibaraki, Japan, 300-0053
        • Recruiting
        • Tsuchiura Kyodo General Hospital /ID# 260732
    • Ishikawa
      • Kanazawa-shi, Ishikawa, Japan, 921-8162
        • Recruiting
        • Kanazawa Red Cross Hospital /ID# 262653
    • Kagawa
      • Takamatsu-shi, Kagawa, Japan, 760-0017
        • Recruiting
        • Takamatsu Red Cross Hospital /ID# 259493
    • Kagoshima
      • Kagoshima-shi, Kagoshima, Japan, 8920804
        • Recruiting
        • Kagoshima IBD Gastroenterology Clinic /ID# 255191
      • Kagoshima-shi, Kagoshima, Japan, 892-0846
        • Recruiting
        • Sameshima Hospital /ID# 256215
    • Kanagawa
      • Atsugi-shi, Kanagawa, Japan, 243-0018
        • Recruiting
        • Atsugi Familly Clinic /ID# 259496
      • Kamakura-shi, Kanagawa, Japan, 247-0056
        • Recruiting
        • Gokeikai Ofuna Chuo Hospital /ID# 259502
      • Kawasaki City, Kanagawa, Japan, 2150026
        • Recruiting
        • Shin-Yurigaoka General Hospital /ID# 265634
      • Sagamihara, Kanagawa, Japan, 252-0375
        • Recruiting
        • Kitasato University Hospital /ID# 267442
      • Yokohama-shi, Kanagawa, Japan, 232-0003
        • Recruiting
        • Koganecho Sukoyaka Clinic /ID# 257014
      • Yokohama-shi, Kanagawa, Japan, 221-0855
        • Recruiting
        • Yokohama Municipal Citizen's Hospital /ID# 259503
      • Yokohama-shi, Kanagawa, Japan, 244-0003
        • Recruiting
        • Yokohama Totsukaekimae Clinic /ID# 259509
      • Yokohama-shi, Kanagawa, Japan, 230-0012
        • Recruiting
        • Saiseikai Yokohamashi Tobu /ID# 261896
    • Kumamoto
      • Kumamoto-shi, Kumamoto, Japan, 862-0971
        • Recruiting
        • Coloproctology Center Takano Hospital /ID# 257041
    • Kyoto
      • Kyoto-shi, Kyoto, Japan, 605-0981
        • Recruiting
        • Japanese Red Cross Kyoto Daiichi Hosital /ID# 256213
      • Kyoto-shi, Kyoto, Japan, 612-8555
        • Recruiting
        • National Hospital Organization Kyoto Medical Center /ID# 259497
    • Mie
      • Tsu-shi, Mie, Japan, 514-8507
        • Recruiting
        • Mie University Hospital /ID# 257011
      • Yokkaichi-shi, Mie, Japan, 510-0016
        • Recruiting
        • Yokkaichi Hazu Medical Center /ID# 257010
    • Miyagi
      • Sendai, Miyagi, Japan, 983-0005
        • Recruiting
        • Tohoku Pharmaceutical University Hospital /ID# 265636
    • Nagano
      • Komagane-shi, Nagano, Japan, 3994117
        • Recruiting
        • Showa Inan General Hospital /ID# 258413
      • Nagano-shi, Nagano, Japan, 388-8004
        • Recruiting
        • Shinonoi General Hospital /ID# 261893
    • Nara
      • Nara-shi, Nara, Japan, 630-8054
        • Recruiting
        • Nara Prefecture General Medical Center /ID# 256211
    • Niigata
      • Nagaoka-shi, Niigata, Japan, 940-2085
        • Recruiting
        • Nagaoka Red Cross Hospital /ID# 255250
      • Niigata-shi, Niigata, Japan, 950-2028
        • Recruiting
        • Yoneyama Clinic /ID# 256210
    • Oita
      • Oita-shi, Oita, Japan, 870-0823
        • Recruiting
        • Ishida Clinic of IBD and Gastroenterology /ID# 252878
    • Okinawa
      • Naha, Okinawa, Japan, 902-0061
        • Recruiting
        • Naha City Hospital /ID# 255249
      • Nakagami-gun, Okinawa, Japan, 903-0215
        • Recruiting
        • University of the Ryukyus Hospital /ID# 257044
      • Okinawa-shi, Okinawa, Japan, 904-2195
        • Recruiting
        • Nakagami Hospital /ID# 256214
    • Osaka
      • Fujidera-shi, Osaka, Japan, 583-0027
        • Recruiting
        • Sai Gastroenterology and Proctology Clinic /ID# 252880
      • Hirakata, Osaka, Japan, 573-0153
        • Recruiting
        • Hirakata Kohsai Hospital /ID# 256216
      • Hirakata-shi, Osaka, Japan, 573-1191
        • Recruiting
        • Kansai Medical University Hospital /ID# 255247
      • Osaka-shi, Osaka, Japan, 530-0011
        • Recruiting
        • Kinshukai Infusion Clinic /ID# 253199
      • Osaka-shi, Osaka, Japan, 553-0002
        • Recruiting
        • Yoshino Medical Clinic /ID# 255192
      • Osaka-shi, Osaka, Japan, 540-0006
        • Recruiting
        • National Hospital Organization Osaka National Hospital /ID# 257042
      • Osaka-shi, Osaka, Japan, 545-8586
        • Recruiting
        • Osaka Metropolitan University Hospital /ID# 258319
      • Osaka-shi, Osaka, Japan, 550-0025
        • Recruiting
        • Tane General Hospital /ID# 259495
      • Sakai-shi, Osaka, Japan, 591-8025
        • Recruiting
        • Osaka Rosai Hospital /ID# 255244
      • Toyonaka-shi, Osaka, Japan, 560-0055
        • Recruiting
        • Toyonaka Municipal Hospital /ID# 258414
    • Saitama
      • Ageo-shi, Saitama, Japan, 362-0075
        • Recruiting
        • Ohmori Toshihide gastro-intestinal Clinic /ID# 256205
      • Kumagaya-shi, Saitama, Japan, 331-0074
        • Recruiting
        • Kumagaya General Hospital /ID# 261294
    • Shiga
      • Otsu-shi, Shiga, Japan, 520-2192
        • Recruiting
        • Shiga University of Medical Science Hospital /ID# 258323
    • Shizuoka
      • Hamamatsu-shi, Shizuoka, Japan, 432-8061
        • Recruiting
        • Kato Clinic /ID# 254489
      • Hamamatsu-shi, Shizuoka, Japan, 431-3192
        • Recruiting
        • Hamamatsu University Hospital /ID# 258438
      • Hamamatsu-shi, Shizuoka, Japan, 433-8113
        • Recruiting
        • Kashiwabara Gastroenterology Clinic /ID# 261885
      • Shizuoka-shi, Shizuoka, Japan, 420-0881
        • Recruiting
        • Shizuoka Aoi Clinic /ID# 260219
      • Sunto-gun, Shizuoka, Japan, 411-8611
        • Recruiting
        • NHO Shizuoka Medical Center /ID# 260214
    • Tochigi
      • Mibu, Tochigi, Japan, 321-0293
        • Recruiting
        • Dokkyo Medical University Hospital /ID# 257040
      • Utsunomiya-shi, Tochigi, Japan, 321-0974
        • Recruiting
        • Saiseikai Utsunomiya Hospital /ID# 254488
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8431
        • Recruiting
        • Juntendo University Hospital /ID# 259504
      • Chuo-ku, Tokyo, Japan, 104-0061
        • Recruiting
        • Ginza Central Clinic /ID# 256208
      • Koganei-shi, Tokyo, Japan, 184-0004
        • Recruiting
        • Koganei Tsurukame Clinic /ID# 260215
      • Minato-ku, Tokyo, Japan, 108-8642
        • Recruiting
        • Kitasato University Kitasato Institute Hospital /ID# 258434
      • Minato-ku, Tokyo, Japan, 105-8471
        • Recruiting
        • The Jikei University Hospital /ID# 262652
      • Setagaya-ku, Tokyo, Japan, 155-0032
        • Recruiting
        • Ohori IBD Clinic /ID# 255253
      • Shibuya-ku, Tokyo, Japan, 151-0053
        • Recruiting
        • Shinjuku Tsurukame Clinic /ID# 258443
      • Shinagawa-ku, Tokyo, Japan, 142-8666
        • Recruiting
        • Showa University Hospital /ID# 261898
      • Shinjuku-ku, Tokyo, Japan, 160-0023
        • Recruiting
        • Tokyo Medical University Hospital /ID# 261291
      • Shinjuku-ku, Tokyo, Japan, 160-8582
        • Recruiting
        • Keio University Hospital /ID# 261899
      • Shinjuku-ku, Tokyo, Japan, 162-8666
        • Recruiting
        • Tokyo Women's Medical University Hospital /ID# 261887
      • Shinjuku-ku, Tokyo, Japan, 169-0073
        • Recruiting
        • Japan Community Health care Organization Tokyo Yamate Medical Center /ID# 261886
    • Toyama
      • Toyama-shi, Toyama, Japan, 939-8085
        • Recruiting
        • Yokota Memorial Hospital /ID# 267044
    • Wakayama
      • Wakayama-shi, Wakayama, Japan, 640-8558
        • Recruiting
        • Japanese Red Cross Wakayama Medical Center /ID# 255245
      • Wakayama-shi, Wakayama, Japan, 641-8510
        • Recruiting
        • Wakayama Medical University Hospital /ID# 259506
    • Yamaguchi
      • Yamaguchi-shi, Yamaguchi, Japan, 753-8519
        • Recruiting
        • Yamaguchi Red Cross Hospital /ID# 257016
    • Yamanashi
      • Kofu-shi, Yamanashi, Japan, 400-0813
        • Recruiting
        • Iwamoto Naika Onaka Clinic /ID# 261888

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Participants Receiving Upadacitinib
Participants receiving upadacitinib for moderate to severe Ulcerative colitis (UC) in real-world practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence Percentage of Serious Infection Reported as Adverse Drug Reaction (ADR)
Time Frame: Up to 60 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2022

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

November 30, 2025

Study Registration Dates

First Submitted

March 17, 2023

First Submitted That Met QC Criteria

March 17, 2023

First Posted (Actual)

March 30, 2023

Study Record Updates

Last Update Posted (Actual)

April 26, 2024

Last Update Submitted That Met QC Criteria

April 25, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P22-962

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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