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Crohn's DiseaseNCT06023030

An Observational Study to Assess Change in Disease Activity and Adverse Events in Adolescent and Adult Participants With Moderate to Severe Active Crohn's Disease (CD) in Japan

An observational study of Crohn's Disease, run by AbbVie at 104 sites in Japan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. This study will assess how safe and effective upadacitinib is in treating moderately to severely active CD in real world. Adverse events and change in disease activity will be assessed. Read more about this study

Who is it for?
Ages 15 years and older
Conditions the study is for
Crohn's Disease
How many people
240 participants
Where
104 sitesJapan
Study dates
28 Jul 2023to May 2027
Phase
Observational
Are there results?
Not yet: the study is under way

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: Children and Adult participants with Crohn's disease (CD) in Japan.

Who may be able to join

  • Diagnosed with moderately to severely active Crohn's disease (CD).
  • Has been prescribed upadacitinib for CD as per most current local approved label after its approval for CD in Japan.
  • Within 14 days from the commencement of upadacitinib induction treatment for CD at the participating institution.

Who cannot join

  • Currently participating in another interventional clinical research.
  • Participants for whom upadacitinib is contraindicated.
  • Has been treated with upadacitinib for CD before and continue treatment with upadacitinib for CD at the participation to this study.

Trial locations and contacts

104 sites in 1 country. Contact the study team or a site near you to ask about taking part.

AbbVie GK Clinical Trial Registration Desk contact

+81-3-4577-1111

abbvie_jpn_info_clingov@abbvie.com

104 sites in 1 country

Japan104 sites, 104 recruiting

  • Ohmori Toshihide Gastrointestinal Clinic /ID# 276192

    Ageo, Saitama, 362-0075

    Recruiting

  • Ako-City Hospital /ID# 271276

    Ako, Hyōgo, 678-0232

    Recruiting

  • Anjou Kousei Hospital /ID# 261872

    Anjo-shi, Aichi-ken, 446-8602

    Recruiting

  • Juntendo University Hospital /ID# 265452

    Bunkyo-ku, Tokyo, 113-8431

    Recruiting

  • Fukuoka University Chikushi Hospital /ID# 262686

    Chikushino-shi, Fukuoka, 818-8502

    Recruiting

  • Ginza Central Clinic /ID# 261881

    Chuo-ku, Tokyo, 104-0061

    Recruiting

  • Fukuiken Saiseikai Hospital /ID# 274835

    Fukui, 918-8235

    Recruiting

  • Sakemi clinic /ID# 275589

    Fukuoka, Fukuoka, 813-0003

    Recruiting

  • Fukushima Red Cross Hospital /ID# 275322

    Fukushima, 960-8530

    Recruiting

  • National Hospital Organization Fukuyama Medical Center /ID# 261873

    Fukuyama-shi, Hiroshima, 720-8520

    Recruiting

  • Gifu University Hospital /ID# 266711

    Gifu, Gifu, 501-1194

    Recruiting

  • University of the Ryukyus Hospital /ID# 264430

    Ginowan-shi, Okinawa, 901-2725

    Recruiting

  • Hachinohe City Hospital /ID# 264183

    Hachinohe, Aomori, 031-0011

    Recruiting

  • Kato Clinic /ID# 262650

    Hamamatsu, Shizuoka, 432-8061

    Recruiting

  • Handa City Hospital /ID# 270446

    Handa, Aichi-ken, 475-8599

    Recruiting

  • JA Hiroshima General Hospital /ID# 264432

    Hatsukaichi, Hiroshima, 738-8503

    Recruiting

  • Himeji Chuo Hospital /ID# 272714

    Himeji, Hyōgo, 672-8501

    Recruiting

  • Japanease Red Cross Society Himeji Hospital /ID# 275590

    Himeji, 670-8540

    Recruiting

  • Hyogo Prefectural Harima-Himeji General Medical Center /ID# 274528

    Himeji-shi, Hyōgo, 670-0836

    Recruiting

  • Kaisei Clinic /ID# 261883

    Hiroshima, Hiroshima, 730-0017

    Recruiting

  • Seshimo Gastroy & Procto Clinic /ID# 271658

    Ibaraki-shi, Osaka, 567-0882

    Recruiting

  • Tokai University Hospital /ID# 270949

    Isehara, Kanagawa, 259-1193

    Recruiting

  • Itami City Hospital /ID# 276258

    Itami, Hyōgo, 664-8540

    Recruiting

  • Kagoshima IBD Gastroenterology Clinic /ID# 265505

    Kagoshima, Kagoshima-ken, 892-0843

    Recruiting

  • Sakura Clinic /ID# 268344

    Kakamigahara-shi, Gifu, 504-0907

    Recruiting

  • Gokeikai Ofuna Chuo Hospital /ID# 262649

    Kamakura-shi, Kanagawa, 247-0056

    Recruiting

  • National Hospital Organization Kanazawa Medical Center /ID# 268820

    Kanazawa, Ishikawa-ken, 920-8650

    Recruiting

  • Tsujinaka Hospital - Kashiwanoha /ID# 262648

    Kashiwa-shi, Chiba, 277-0871

    Recruiting

  • Saitama Medical Center /ID# 270948

    Kawagoe, Saitama, 350-8550

    Recruiting

  • Tobata Kyoritsu Hospital /ID# 273558

    Kitakyushu, Fukuoka, 804-0093

    Recruiting

  • Steel Memorial Yahata Hospital /ID# 272713

    Kitakyushu, Fukuoka, 805-0050

    Recruiting

  • Kitakyushu Municipal Medical Center /ID# 276257

    Kitakyushu-shi, Fukuoka, 802-0077

    Recruiting

  • Aoyama Clinic /ID# 262658

    Kobe, Hyōgo, 650-0015

    Recruiting

  • Kobe City Medical Center General Hospital /ID# 270950

    Kobe, Hyōgo, 650-0047

    Recruiting

  • Chikamori Hospital /ID# 267382

    Kochi, Kochi, 780-8522

    Recruiting

  • Kuniyoshi Hospital /ID# 271878

    Kochi, 780-0901

    Recruiting

  • Yamanashi Prefectural Central Hospital /ID# 274526

    Kofu, Yamanashi, 400-0027

    Recruiting

  • Koganei Tsurukame Clinic /ID# 271660

    Koganei-shi, Tokyo, 184-0004

    Recruiting

  • Southern Tohoku General Hospital /ID# 270447

    Kōriyama, Fukushima, 963-8563

    Recruiting

  • Coloproctology Center Takano Hospital /ID# 268868

    Kumamoto, Kumamoto, 862-0971

    Recruiting

  • Hidaka Colon Proctology Clinic /ID# 268867

    Kurume, Fukuoka, 839-0809

    Recruiting

  • Hakuai Clinic /ID# 261876

    Kurume-shi, Fukuoka, 839-0863

    Recruiting

  • Japanese Red Cross Kyoto Daiichi Hosital /ID# 262660

    Kyoto, Kyoto, 605-0981

    Recruiting

  • National Hospital Organization Kyoto Medical Center /ID# 265461

    Kyoto, Kyoto, 612-8555

    Recruiting

  • Matsuyama Red Cross Hospital /ID# 266717

    Matsuyama, Ehime, 790-8524

    Recruiting

  • Dokkyo Medical University Hospital /ID# 266710

    Mibu, Tochigi, 321-0293

    Recruiting

  • Kitasato University Kitasato Institute Hospital /ID# 268345

    Minato-ku, Tokyo, 108-8642

    Recruiting

  • Moriguchi Keijinkai Hospital /ID# 268821

    Moriguchi, Osaka, 570-0013

    Recruiting

  • Aichi Medical University Hospital /ID# 261871

    Nagakute, Aichi-ken, 480-1195

    Recruiting

  • Nagano Municipal Hospital /ID# 262627

    Nagano, Nagano, 3818551

    Recruiting

  • Honda Internal Medicine and Endoscopy Clinic /ID# 275628

    Nagasaki, Nagasaki, 850-0058

    Recruiting

  • Masuko Memorial Hospital /ID# 267420

    Nagoya, Aichi-ken, 453-0016

    Recruiting

  • Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital /ID# 276219

    Nagoya, Aichi-ken, 453-8511

    Recruiting

  • Nagoya City University Hospital /ID# 275588

    Nagoya, Aichi-ken, 467-8602

    Recruiting

  • Naha City Hospital /ID# 261875

    Naha, Okinawa, 902-0061

    Recruiting

  • Hyogo Medical University Hospital /ID# 267383

    Nishinomiya-shi, Hyōgo, 663-8501

    Recruiting

  • Shimizuogimachi Clinic /ID# 276278

    Odawara-shi, Kanagawa, 250-0001

    Recruiting

  • Ishida Clinic of IBD and Gastroenterology /ID# 261884

    Ōita, Oita Prefecture, 870-0823

    Recruiting

  • Ashiya Central Hospital /ID# 275324

    Onga-gun, Fukuoka, 807-0101

    Recruiting

  • Kita-Harima Medical Center /ID# 276256

    Ono, Hyōgo, 675-1327

    Recruiting

  • Kinshukai Infusion Clinic /ID# 261332

    Osaka, Osaka, 530-0011

    Recruiting

  • National Hospital Organization Osaka National Hospital /ID# 264230

    Osaka, Osaka, 540-0006

    Recruiting

  • Osaka Metropolitan University Hospital /ID# 273559

    Osaka, Osaka, 545-8586

    Recruiting

  • Tane General Hospital /ID# 268871

    Osaka, Osaka, 550-0025

    Recruiting

  • Saga-Ken Medical Centre Koseikan /ID# 274957

    Saga, 840-8571

    Recruiting

  • Kitasato University Hospital /ID# 276524

    Sagamihara-shi, Kanagawa, 252-0375

    Recruiting

  • Saitama City Hospital /ID# 266716

    Saitama, 336-8522

    Recruiting

  • Tokitokai Tokito clinic /ID# 262661

    Saitama-shi, Saitama, 336-0963

    Recruiting

  • Osaka Rosai Hospital /ID# 267379

    Sakai, Osaka, 591-8025

    Recruiting

  • Sapporo Ibd Clinic /ID# 281896

    Sapporo, Hokkaido, 064-0919

    Recruiting

  • Sapporo Kosei General Hospital /ID# 267374

    Sapporo, 060-0033

    Recruiting

  • Ohori IBD Clinic /ID# 261882

    Setagaya-ku, Tokyo, 155-0032

    Recruiting

  • Shinjuku Tsurukame Clinic /ID# 276485

    Shibuya-ku, Tokyo, 151-0053

    Recruiting

  • Tokyo Medical University Hospital /ID# 262683

    Shinjuku-ku, Tokyo, 160-0023

    Recruiting

  • Tokyo Women's Medical University Hospital /ID# 274527

    Shinjuku-ku, Tokyo, 162-8666

    Recruiting

  • Shizuoka Aoi Clinic /ID# 267376

    Shizuoka, Shizuoka, 420-0881

    Recruiting

  • Saigusa Clinic Of Coloproctolo /ID# 275627

    Sizuoka-shi, Shizuoka, 420-0859

    Recruiting

  • Fraternity Memorial Hospital /ID# 274976

    Sumida-ku, Tokyo, 130-8587

    Recruiting

  • NHO Shizuoka Medical Center /ID# 275551

    Sunto-gun, Shizuoka, 411-8611

    Recruiting

  • Takamatsu Red Cross Hospital /ID# 268823

    Takamatsu, Kagawa-ken, 760-0017

    Recruiting

  • Maeda Hospital /ID# 275554

    Takamatsu, Kagawa-ken, 761-8054

    Recruiting

  • Fujita Gastroenterology Hospital /ID# 275410

    Takatsuki, Osaka, 569-0086

    Recruiting

  • Tokorozawa Proctogic Hospital /ID# 268870

    Tokorozawa, Saitama, 359-1141

    Recruiting

  • Tokyo Yamate Medical Center /ID# 275591

    Tokyo, 169-0073

    Recruiting

  • Teikyo University Hospital /ID# 274525

    Tokyo, 173-8605

    Recruiting

  • Teikyo University Hospital /ID# 274977

    Tokyo, 173-8605

    Recruiting

  • Yokota Memorial Hospital /ID# 266714

    Toyama, Toyama, 939-8085

    Recruiting

  • Toyohashi Municipal Hospital /ID# 274975

    Toyohashi, Aichi-ken, 441-8570

    Recruiting

  • Municipal Toyonaka Hospital /ID# 266712

    Toyonaka, 560-0055

    Recruiting

  • Ieda Hospital /ID# 259754

    Toyota-shi, Aichi-ken, 470-1219

    Recruiting

  • Mie University Hospital /ID# 262656

    Tsu, Mie-ken, 514-8507

    Recruiting

  • Tsukuba Endoscopy clinic /ID# 261880

    Tsukuba, Ibaraki, 305-0821

    Recruiting

  • Sentohill Hospital /ID# 268869

    Ube, Yamaguchi, 755-0155

    Recruiting

  • Saiseikai Utsunomiya Hospital /ID# 261878

    Utsunomiya, Tochigi, 321-0974

    Recruiting

  • Uwajima City Hospital /ID# 273444

    Uwajima, Ehime, 798-0061

    Recruiting

  • Japanese Red Cross Wakayama Medical Center /ID# 268822

    Wakayama, Wakayama, 640-8558

    Recruiting

  • Wakayama Medical University Hospital /ID# 262685

    Wakayama, Wakayama, 641-8510

    Recruiting

  • Yamagata Prefectural Central Hospital - Yamagata /ID# 268819

    Yamagata, 990-2292

    Recruiting

  • Yamaguchi Red Cross Hospital /ID# 267381

    Yamaguchi, 753-8519

    Recruiting

  • Yokkaichi Hazu Medical Center /ID# 260140

    Yokkaichi-shi, Mie-ken, 510-0016

    Recruiting

  • Matsushima Hospital /ID# 276486

    Yokohama, Kanagawa, 220-0041

    Recruiting

  • Yokohama Municipal Citizen's Hospital /ID# 267375

    Yokohama, Kanagawa, 221-0855

    Recruiting

  • Inoue Gastroenterology Clinic /ID# 275555

    Yokohama, Kanagawa, 223-0053

    Recruiting

  • Saiseikai Yokohama Tobu Hospital /ID# 264186

    Yokohama, Kanagawa, 230-0012

    Recruiting

Other trials in Japan

About this study

Official title: A Post-marketing Non-interventional Study for Upadacitinib in Patients With Moderately to Severely Active Crohn's Disease (CD) in Japan

Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. This study will assess how safe and effective upadacitinib is in treating moderately to severely active CD in real world. Adverse events and change in disease activity will be assessed.

Upadacitinib is a drug approved for the treatment of CD. All study participants will receive upadacitinib as prescribed by their study doctor in accordance with approved local label. Approximately 240 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 64 weeks.

There is expected to be no additional burden for participants in this trial. Study visits may be conducted on-site or virtually as per standard of care.

Conditions
Crohn's Disease
Keywords
Crohn's disease, Upadacitinib
Medical subject headings
Crohn Disease

What participants receive

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

Study groups in NCT06023030
Study groupRoleWhat they receive
UpadacitinibParticipants will receive upadacitinib as prescribed by their physician according to local label.

What is being measured

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

  1. Percentage of Participants with Drug Related Serious Infections

    Pecentage of participants with serious infections.

    Measured: Up to 64 Weeks

Timeline

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

  1. First posted5 Sep 2023
  2. Study start28 Jul 2023
  3. Primary completionNov 2026 (estimated)
  4. Study completionMay 2027 (estimated)

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
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06023030
Sponsor's protocol ID
P24-080
Status last verified
Feb 2026
First submitted
29 Aug 2023
Last updated
24 Feb 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 Crohn's Disease, run by AbbVie at 104 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: looking for participants now, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 104 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?

This study is still under way. Results are not available in the source record yet.

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

Contact AbbVie GK Clinical Trial Registration Desk (+81-3-4577-1111, abbvie_jpn_info_clingov@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants with Drug Related Serious Infections (time frame: Up to 64 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 NCT06023030.

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 24 Feb 2026.

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