Assessing Rinvoq for treating moderate to severe ulcerative colitis in adults in Japan
A Prospective Observational Study for Evaluation of Safety and Effectiveness of Rinvoq in Moderately to Severely Active Ulcerative Colitis; a Japanese Post-Marketing Study
This study is testing how well Rinvoq works and how safe it is for adults in Japan with moderate to severe ulcerative colitis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 15 Years and up |
| Sex | All |
| Sponsor | AbbVie Industry-sponsored |
| Drugs / interventions | upadacitinib |
| Locations | 108 sites (Anjo-shi, Aichi and 107 other locations) |
| Trial ID | NCT05791526 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the safety and effectiveness of Rinvoq (upadacitinib) in adult patients with moderate to severe ulcerative colitis (UC) in Japan. Approximately 300 participants will be enrolled and monitored for changes in disease activity and adverse events over a period of up to 60 weeks. Participants will receive Rinvoq as prescribed by their healthcare providers, following the approved local label. The study aims to gather real-world data on the drug's performance in a clinical setting without imposing additional burdens on participants.
Who should consider this trial
Good fit: Ideal candidates include adults diagnosed with moderately to severely active ulcerative colitis who are starting treatment with Rinvoq.
Not a fit: Patients who are contraindicated for Rinvoq or have previously been treated with it may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness and safety of Rinvoq for patients with moderate to severe ulcerative colitis.
How similar studies have performed: Other studies have shown positive outcomes with Rinvoq in treating ulcerative colitis, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Anjo-shi, Aichi and 107 other locations
- Anjou Kousei Hospital /ID# 256207 — Anjo-shi, Aichi, Japan (Recruiting)
- Ichinomiyanishi Hospital /ID# 259498 — Ichinomiya-shi, Aichi, Japan (Recruiting)
- Aikawa Minnano-shinryojo /ID# 258447 — Nagoya-shi, Aichi, Japan (Recruiting)
- Shimozato Clinic /ID# 261901 — Nagoya-shi, Aichi, Japan (Recruiting)
- Miwa Internist and Gastroenterology Clinic Aoi /ID# 267049 — Nagoya-shi, Aichi, Japan (Recruiting)
- Yamada Coloproctology Clinic /ID# 259508 — Niwa-gun, Aichi, Japan (Recruiting)
- Ieda Hospital /ID# 257012 — Toyota-shi, Aichi, Japan (Recruiting)
- Asahi General Hospital /ID# 258446 — Asahi-shi, Chiba, Japan (Recruiting)
- Chiba Clinic /ID# 257015 — Chiba-shi, Chiba, Japan (Recruiting)
- Nippon Medical Chiba Hokusoh Hospital /ID# 259505 — Inzai-shi, Chiba, Japan (Recruiting)
- Tsujinaka Hospital Kashiwanoha /ID# 257013 — Kashiwa-shi, Chiba, Japan (Recruiting)
- Juntendo University Urayasu Hospital /ID# 265635 — Urayasu, Chiba, Japan (Recruiting)
- Matsuyama Red Cross Hospital /ID# 260211 — Matsuyama-shi, Ehime, Japan (Recruiting)
- Kobayashi Clinic /ID# 265631 — Chikugo-shi, Fukuoka, Japan (Recruiting)
- Fukuoka University Chikushi Hospital /ID# 255248 — Chikushino-shi, Fukuoka, Japan (Recruiting)
- Sakemi clinic /ID# 261889 — Fukuoka-shi, Fukuoka, Japan (Recruiting)
- Tobata Kyoritsu Hospital /ID# 257043 — Kitakyusyu-shi, Fukuoka, Japan (Recruiting)
- Hidaka Clinic of Coloproctology /ID# 252879 — Kurume-shi, Fukuoka, Japan (Recruiting)
- Hoshi General Hospital /ID# 261292 — Koriyama City, Fukushima, Japan (Recruiting)
- Gifu Municipal Hospital /ID# 255254 — Gifu-shi, Gifu, Japan (Recruiting)
- Gifu University Hospital /ID# 258435 — Gifu-shi, Gifu, Japan (Recruiting)
- Mori Surgical Clinic /ID# 258445 — Ogaki-shi, Gifu, Japan (Recruiting)
- Chuno Kosei Hospital /ID# 263042 — Seki City, Gifu, Japan (Recruiting)
- Gifu Prefectural Tajimi Hosp /ID# 260213 — Tajimi-shi, Gifu, Japan (Recruiting)
- Kudo Gastroenterology Clinic /ID# 255251 — Takasaki-shi, Gunma, Japan (Recruiting)
- NHO Fukuyama Medical Center /ID# 255246 — Fukuyama-shi, Hiroshima, Japan (Recruiting)
- Kaisei Clinic /ID# 258441 — Hiroshima-shi, Hiroshima, Japan (Recruiting)
- Hiroshima University Hospital /ID# 257045 — Hiroshima-shi, Hiroshima, Japan (Recruiting)
- Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 258437 — Sapporo-shi, Hokkaido, Japan (Recruiting)
- Sapporo IBD Clinic /ID# 255255 — Sapporo-shi, Hokkaido, Japan (Recruiting)
- Kobe University Hospital /ID# 260212 — Kobe-shi, Hyogo, Japan (Recruiting)
- Nishi-Kobe Medical Center /ID# 258433 — Kobe-shi, Hyogo, Japan (Recruiting)
- Hida Endoscopy Clinic /ID# 255252 — Nishinomiya-shi, Hyogo, Japan (Recruiting)
- Hyogo Medical University Hospital /ID# 259500 — Nishinomiya-shi, Hyogo, Japan (Recruiting)
- Hitachinaka General Hospital /ID# 256209 — Hitachinaka-shi, Ibaraki, Japan (Recruiting)
- Tokyo Medical University Ibaraki Medical Center /ID# 260210 — Inashiki-shi, Ibaraki, Japan (Recruiting)
- Koyama Memorial Hospital /ID# 256212 — Kashima City, Ibaraki, Japan (Recruiting)
- Tsuchiura Kyodo General Hospital /ID# 260732 — Tsuchiura-shi, Ibaraki, Japan (Recruiting)
- Kanazawa Red Cross Hospital /ID# 262653 — Kanazawa-shi, Ishikawa, Japan (Recruiting)
- Takamatsu Red Cross Hospital /ID# 259493 — Takamatsu-shi, Kagawa, Japan (Recruiting)
- Sameshima Hospital /ID# 256215 — Kagoshima-shi, Kagoshima, Japan (Recruiting)
- Kagoshima IBD Gastroenterology Clinic /ID# 255191 — Kagoshima-shi, Kagoshima, Japan (Recruiting)
- Atsugi Familly Clinic /ID# 259496 — Atsugi-shi, Kanagawa, Japan (Recruiting)
- Gokeikai Ofuna Chuo Hospital /ID# 259502 — Kamakura-shi, Kanagawa, Japan (Recruiting)
- Shin-Yurigaoka General Hospital /ID# 265634 — Kawasaki City, Kanagawa, Japan (Recruiting)
- Kitasato University Hospital /ID# 267442 — Sagamihara, Kanagawa, Japan (Recruiting)
- Yokohama Municipal Citizen's Hospital /ID# 259503 — Yokohama-shi, Kanagawa, Japan (Recruiting)
- Saiseikai Yokohamashi Tobu /ID# 261896 — Yokohama-shi, Kanagawa, Japan (Recruiting)
- Koganecho Sukoyaka Clinic /ID# 257014 — Yokohama-shi, Kanagawa, Japan (Recruiting)
- Yokohama Totsukaekimae Clinic /ID# 259509 — Yokohama-shi, Kanagawa, Japan (Recruiting)
+58 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: AbbVie GK Clinical Trial Registration Desk
- Email: abbvie_jpn_info_clingov@abbvie.com
- Phone: +81-3-4577-1111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.