AzTrials
AzTrials

Ulcerative ColitisNCT05791526

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

An observational study of Ulcerative Colitis, run by AbbVie at 114 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 15 years and older
Conditions the study is for
Ulcerative Colitis
How many people
308 participants
Where
114 sitesJapan
Study dates
19 Dec 2022to 9 Dec 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

114 sites in 1 country.

114 sites in 1 country

Japan114 sites

  • Ohmori Toshihide gastro-intestinal Clinic /ID# 256205

    Ageo-shi, Saitama, 362-0075

  • Anjou Kousei Hospital /ID# 256207

    Anjo-shi, Aichi-ken, 446-8602

  • Aomori Prefectural Central Hospital /ID# 266719

    Aomori, 030-0913

  • Asahi General Hospital /ID# 258446

    Asahi, Chiba, 289-2511

  • Atsugi Familly Clinic /ID# 259496

    Atsugi-shi, Kanagawa, 243-0018

  • Juntendo University Hospital /ID# 259504

    Bunkyo-ku, Tokyo, 113-8431

  • Chiba Clinic /ID# 257015

    Chiba, Chiba, 260-0018

  • Kobayashi Clinic /ID# 265631

    Chikugo-shi, Fukuoka, 833-0005

  • Fukuoka University Chikushi Hospital /ID# 255248

    Chikushino-shi, Fukuoka, 818-8502

  • Ginza Central Clinic /ID# 256208

    Chuo-ku, Tokyo, 104-0061

  • Sai Gastroenterology and Proctology Clinic /ID# 252880

    Fujidera-shi, Osaka, 583-0027

  • Sakemi clinic /ID# 261889

    Fukuoka, Fukuoka, 813-0003

  • National Hospital Organization Fukuyama Medical Center /ID# 255246

    Fukuyama-shi, Hiroshima, 720-8520

  • Fukutomi Icyo Clinic /ID# 267047

    Gifu, Gifu, 500-8175

  • Gifu Municipal Hospital /ID# 255254

    Gifu, Gifu, 500-8323

  • Gifu University Hospital /ID# 258435

    Gifu, Gifu, 501-1194

  • University of the Ryukyus Hospital /ID# 257044

    Ginowan-shi, Okinawa, 901-2725

  • Hachinohe City Hospital /ID# 256198

    Hachinohe-shi, Aomori, 031-8555

  • Hamamatsu University Hospital /ID# 258438

    Hamamatsu, Shizuoka, 431-3192

  • Kato Clinic /ID# 254489

    Hamamatsu, Shizuoka, 432-8061

  • Kashiwabara Gastroenterology Clinic /ID# 261885

    Hamamatsu, Shizuoka, 433-8113

  • Hirakata Kohsai Hospital /ID# 256216

    Hirakata, Osaka, 573-0153

  • Kansai Medical University Hospital /ID# 255247

    Hirakata-shi, Osaka, 573-1191

  • Kaisei Clinic /ID# 258441

    Hiroshima, Hiroshima, 730-0017

  • Hiroshima University Hospital /ID# 257045

    Hiroshima, Hiroshima, 734-8551

  • Hitachinaka General Hospital /ID# 256209

    Hitachi-Naka, Ibaraki, 312-0057

  • Ichinomiyanishi Hospital /ID# 259498

    Ichinomiya-shi, Aichi-ken, 494-0001

  • Tokyo Medical University Ibaraki Medical Center /ID# 260210

    Inashiki-shi, Ibaraki, 300-0332

  • Nippon Medical Chiba Hokusoh Hospital /ID# 259505

    Inzai-shi, Chiba, 270-1613

  • Sameshima Hospital /ID# 256215

    Kagoshima, Kagoshima-ken, 892-0846

  • Kagoshima IBD Gastroenterology Clinic /ID# 255191

    Kagoshima, Kagoshima-ken, 8920804

  • Gokeikai Ofuna Chuo Hospital /ID# 259502

    Kamakura-shi, Kanagawa, 247-0056

  • Kanazawa Red Cross Hospital /ID# 262653

    Kanazawa, Ishikawa-ken, 921-8162

  • Koyama Memorial Hospital /ID# 256212

    Kashima-shi, Ibaraki, 314-0030

  • Tsujinaka Hospital - Kashiwanoha /ID# 257013

    Kashiwa-shi, Chiba, 277-0871

  • Shin-Yurigaoka General Hospital /ID# 265634

    Kawasaki-shi, Kanagawa, 215-0026

  • Tobata Kyoritsu Hospital /ID# 257043

    Kitakyusyu-shi, Fukuoka, 803-0836

  • Kobe University Hospital /ID# 260212

    Kobe, Hyōgo, 650-0017

  • Nishi-Kobe Medical Center /ID# 258433

    Kobe, Hyōgo, 651-2273

  • Iwamoto Naika Onaka Clinic /ID# 261888

    Kofu, Yamanashi, 400-0813

  • Koganei Tsurukame Clinic /ID# 260215

    Koganei-shi, Tokyo, 184-0004

  • Showa Inan General Hospital /ID# 258413

    Komagane-shi, Nagano, 3994117

  • Southern Tohoku General Hospital /ID# 267043

    Kōriyama, Fukushima, 963-8563

  • Hoshi General Hospital /ID# 261292

    Koriyama-shi, Fukushima, 963-8501

  • Kumagaya General Hospital /ID# 261294

    Kumagaya-shi, Saitama, 331-0074

  • Coloproctology Center Takano Hospital /ID# 257041

    Kumamoto, Kumamoto, 862-0971

  • Hattori Clinic - Kumamoto /ID# 263978

    Kumamoto, 860-0004

  • Hidaka Clinic of Coloproctology /ID# 252879

    Kurume-shi, Fukuoka, 839-0809

  • Japanese Red Cross Kyoto Daiichi Hosital /ID# 256213

    Kyoto, Kyoto, 605-0981

  • National Hospital Organization Kyoto Medical Center /ID# 259497

    Kyoto, Kyoto, 612-8555

  • Matsuyama Red Cross Hospital /ID# 260211

    Matsuyama, Ehime, 790-8524

  • Dokkyo Medical University Hospital /ID# 257040

    Mibu, Tochigi, 321-0293

  • Kitasato University Kitasato Institute Hospital /ID# 258434

    Minato-ku, Tokyo, 108-8642

  • Kyorin University Hospital /ID# 261293

    Mitaka-shi, Tokyo, 181-8611

  • Shinonoi General Hospital /ID# 261893

    Nagano, Nagano, 388-8004

  • Nagaoka Red Cross Hospital /ID# 255250

    Nagaoka-shi, Niigata, 940-2085

  • Nagasaki Harbor Medical Center /ID# 264425

    Nagasaki, 850-0842

  • Aikawa Minnano-shinryojo /ID# 258447

    Nagoya, Aichi-ken, 458-0011

  • Shimozato Clinic /ID# 261901

    Nagoya, Aichi-ken, 458-0044

  • Miwa Internist and Gastroenterology Clinic Aoi /ID# 267049

    Nagoya, Aichi-ken, 461-0004

  • Naha City Hospital /ID# 255249

    Naha, Okinawa, 902-0061

  • Nara Prefecture General Medical Center - Nara /ID# 256211

    Nara, Nara, 630-8581

  • Yoneyama Clinic /ID# 256210

    Niigata, Niigata, 950-2028

  • Hida Endoscopy Clinic /ID# 255252

    Nishinomiya-shi, Hyōgo, 662-0973

  • Hyogo Medical University Hospital /ID# 259500

    Nishinomiya-shi, Hyōgo, 663-8501

  • Yamada Coloproctology Clinic /ID# 259508

    Niwa-gun, Aichi-ken, 480-0147

  • Mori Surgical Clinic /ID# 258445

    Ogaki-shi, Gifu, 503-0031

  • Ishida Clinic of IBD and Gastroenterology /ID# 252878

    Ōita, Oita Prefecture, 870-0823

  • Okayama University Hospital /ID# 262651

    Okayama, Okayama-ken, 700-8558

  • Nakagami Hospital /ID# 256214

    Okinawa-shi, Okinawa, 904-2195

  • Kinshukai Infusion Clinic /ID# 253199

    Osaka, Osaka, 530-0011

  • National Hospital Organization Osaka National Hospital /ID# 257042

    Osaka, Osaka, 540-0006

  • Osaka Metropolitan University Hospital /ID# 258319

    Osaka, Osaka, 545-8586

  • Tane General Hospital /ID# 259495

    Osaka, Osaka, 550-0025

  • Yoshino Medical Clinic /ID# 255192

    Osaka, Osaka, 553-0002

  • Shiga University of Medical Science Hospital /ID# 258323

    Ōtsu, Shiga, 520-2192

  • Kitasato University Hospital /ID# 267442

    Sagamihara-shi, Kanagawa, 252-0375

  • Osaka Rosai Hospital /ID# 255244

    Sakai-shi, Osaka, 591-8025

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

    Sapporo, Hokkaido, 060-0033

  • Sapporo IBD Clinic /ID# 255255

    Sapporo, Hokkaido, 064-0919

  • Chuno Kosei Hospital /ID# 263042

    Seki-shi, Gifu, 501-3802

  • Tohoku Medical and Pharmaceutical University Hospital /ID# 265636

    Sendai, Miyagi, 983-8512

  • Ohori IBD Clinic /ID# 255253

    Setagaya-ku, Tokyo, 155-0032

  • Shinjuku Tsurukame Clinic /ID# 258443

    Shibuya-ku, Tokyo, 151-0053

  • Showa University Hospital /ID# 261898

    Shinagawa-ku, Tokyo, 142-8666

  • Tokyo Medical University Hospital /ID# 261291

    Shinjuku-ku, Tokyo, 160-0023

  • Keio University Hospital /ID# 261899

    Shinjuku-ku, Tokyo, 160-8582

  • Tokyo Women's Medical University Hospital /ID# 261887

    Shinjuku-ku, Tokyo, 162-8666

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

    Shinjuku-ku, Tokyo, 169-0073

  • Shizuoka Aoi Clinic /ID# 260219

    Shizuoka, Shizuoka, 420-0881

  • NHO Shizuoka Medical Center /ID# 260214

    Sunto-gun, Shizuoka, 411-8611

  • Gifu Prefectural Tajimi Hosp /ID# 260213

    Tajimi-shi, Gifu, 507-8522

  • Takamatsu Red Cross Hospital /ID# 259493

    Takamatsu, Kagawa-ken, 760-0017

  • Kudo Gastroenterology Clinic /ID# 255251

    Takasaki-shi, Gunma, 370-0848

  • St. Luke's International Hospital /ID# 264301

    Tokyo, 104-8560

  • The Jikei University Hospital /ID# 262652

    Tokyo, 105-8461

  • Yokota Memorial Hospital /ID# 267044

    Toyama, Toyama, 939-8085

  • Toyohashi Municipal Hospital /ID# 267048

    Toyohashi, Aichi-ken, 441-8570

  • Toyonaka Municipal Hospital /ID# 258414

    Toyonaka-shi, Osaka, 560-0055

  • Ieda Hospital /ID# 257012

    Toyota-shi, Aichi-ken, 470-1219

  • Mie University Hospital /ID# 257011

    Tsu, Mie-ken, 514-8507

  • Tsuchiura Kyodo General Hospital /ID# 260732

    Tsuchiura-shi, Ibaraki, 300-0053

  • Urasoe General Hospital /ID# 267042

    Urasoe, Okinawa, 901-2132

  • Juntendo University Urayasu Hospital /ID# 265635

    Urayasu, Chiba, 279-0021

  • Saiseikai Utsunomiya Hospital /ID# 254488

    Utsunomiya, Tochigi, 321-0974

  • Japanese Red Cross Wakayama Medical Center /ID# 255245

    Wakayama, Wakayama, 640-8558

  • Wakayama Medical University Hospital /ID# 259506

    Wakayama, Wakayama, 641-8510

  • Yamaguchi Red Cross Hospital /ID# 257016

    Yamaguchi, Yamaguchi, 753-8519

  • Yokkaichi Hazu Medical Center /ID# 257010

    Yokkaichi-shi, Mie-ken, 510-0016

  • Yokohama Municipal Citizen's Hospital /ID# 259503

    Yokohama, Kanagawa, 221-0855

  • Saiseikai Yokohamashi Tobu /ID# 261896

    Yokohama, Kanagawa, 230-0012

  • Koganecho Sukoyaka Clinic /ID# 257014

    Yokohama, Kanagawa, 232-0003

  • Yokohama Totsukaekimae Clinic /ID# 259509

    Yokohama, Kanagawa, 244-0003

  • Tottori University Hospital /ID# 265633

    Yonago, Tottori, 683-8504

Other trials in Japan

About this study

Official title: 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.

Read more

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.

Keywords
Ulcerative colitis, UC, Rinvoq, Upadacitinib
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05791526
Study groupRoleWhat they receive
Participants Receiving UpadacitinibParticipants receiving upadacitinib for moderate to severe Ulcerative colitis (UC) in real-world practice.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 60 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2023
  2. Study start19 Dec 2022
  3. Primary completion9 Dec 2025
  4. Study completion9 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
308 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05791526
Sponsor's protocol ID
P22-962
Status last verified
Sep 2026
First submitted
17 Mar 2023
Last updated
5 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Ulcerative Colitis, run by AbbVie at 114 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 114 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence Percentage of Serious Infection Reported as Adverse Drug Reaction (ADR) (time frame: Up to 60 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05791526.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in