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
Launched by ABBVIE · Aug 29, 2023
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the effects of a medication called upadacitinib on people with moderate to severe Crohn's disease, a long-term condition that causes inflammation in the digestive tract. The goal is to see how well this drug works and whether it causes any side effects in a real-world setting. Approximately 240 participants in Japan will be enrolled in the study, and they will be given upadacitinib as prescribed by their doctors, following local guidelines. The study will follow participants for up to 64 weeks to track changes in their disease activity and any adverse events.
To be eligible for this trial, participants must have a diagnosis of moderately to severely active Crohn's disease and must have started taking upadacitinib within the last two weeks as part of their regular treatment. It's important to note that individuals currently involved in other clinical trials or those who cannot take upadacitinib for health reasons will not be eligible. Participants can expect minimal disruption to their routine, as study visits may take place in person or online, depending on their standard care process.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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.
- Exclusion Criteria:
- • 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.
About Abbvie
AbbVie is a global biopharmaceutical company dedicated to developing innovative therapies that address complex health challenges. Founded in 2013 as a spin-off from Abbott Laboratories, AbbVie focuses on key therapeutic areas, including immunology, oncology, neuroscience, and virology. The company is committed to advancing scientific research and delivering groundbreaking treatments that enhance patient outcomes and quality of life. With a robust pipeline and a strong emphasis on collaboration, AbbVie strives to transform the future of medicine through its commitment to clinical excellence and patient-centered approaches.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Toyota Shi, Aichi, Japan
Yokkaichi Shi, Mie, Japan
Osaka Shi, Osaka, Japan
Anjo Shi, Aichi, Japan
Nagakute Shi, Aichi, Japan
Fukuyama Shi, Hiroshima, Japan
Hiroshima Shi, Hiroshima, Japan
Oita Shi, Oita, Japan
Naha Shi, Okinawa, Japan
Utsunomiya Shi, Tochigi, Japan
Chuo Ku, Tokyo, Japan
Setagaya Ku, Tokyo, Japan
Kurume Shi, Fukuoka, Japan
Tsukuba Shi, Ibaraki, Japan
Kashiwa Shi, Chiba, Japan
Chikushino Shi, Fukuoka, Japan
Kobe Shi, Hyogo, Japan
Kamakura Shi, Kanagawa, Japan
Kyoto Shi, Kyoto, Japan
Tsu Shi, Mie, Japan
Nagano Shi, Nagano, Japan
Saitama Shi, Saitama, Japan
Hamamatsu Shi, Shizuoka, Japan
Shinjuku Ku, Tokyo, Japan
Wakayama Shi, Wakayama, Japan
Nishihara, Okinawa, Japan
Naha, Okinawa, Japan
Tokyo, , Japan
Hachinohe, Aomori, Japan
Hatsukaichi, Hiroshima, Japan
Yokohama, Kanagawa, Japan
Shimotsuga Gun, Tochigi, Japan
Kagoshima, , Japan
Kyoto, , Japan
Osaka, , Japan
Mibu, Tochigi, Japan
Sapporo, , Japan
Nishinomiya, , Japan
Nagakute, Aichi, Japan
Nagoya, Aichi, Japan
Matsuyama Shi, Ehime, Japan
Osaka, Fukui, Japan
Tokyo, Fukui, Japan
Kurume, Fukuoka, Japan
Kakamigahara Shi, Gifu, Japan
Kanazawa, Ishikawa, Japan
Takamatsu, Kagawa, Japan
Yokohama, Kanagawa, Japan
Kochi City, Kochi, Japan
Kumamoto Shi, Kumamoto, Japan
Moriguchi City, Osaka, Japan
Osaka Shi, Osaka, Japan
Sakai City, Osaka, Japan
Tokorozawa, Saitama, Japan
Shizuoka Shi, Shizuoka, Japan
Toyama Shi, Toyama, Japan
Ube, Yamaguchi, Japan
Gifu, , Japan
Saitama, , Japan
Toyonaka, , Japan
Wakayama, , Japan
Yamagata, , Japan
Yamaguchi, , Japan
Handa, Aichi, Japan
Koriyama, Fukushima, Japan
松山市, Ehime, Japan
Kobe Shi, Hyogo, Japan
Nishinomiya, Hyogo, Japan
Isehara, Kanagawa, Japan
Kawagoe, Saitama, Japan
Matsuyama, Ehime, Japan
Koganei Shi, Tokyo, Japan
Ako, Hyogo, Japan
Yokohama Shi, Kanagawa, Japan
Kyoto Shi, Kyoto, Japan
Bunkyo Ku, Tokyo, Japan
Tokyo, , Japan
Kitakyushu, Fukuoka, Japan
Himeji, Hyogo, Japan
Ibaraki Shi, Osaka, Japan
Kochi, , Japan
Osaka City, Osaka, Japan
Shinjuku Ku, Tokyo, Japan
Kofu, Yamanashi, Japan
Toyohashi, Aichi, Japan
Uwajima, Ehime, Japan
Kitakyushu, Fukuoka, Japan
姫路市, Hyogo, Japan
Ginowan Shi, Okinawa, Japan
Osaka Shi, Osaka, Japan
Osaka Shi, Osaka, Japan
Sumida Ku, Tokyo, Japan
Fukui, , Japan
Tokyo, , Japan
Tokyo, , Japan
Fukushima, , Japan
Takatsuki, Osaka, Japan
Nagoya, Aichi, Japan
Yokohama, Kanagawa, Japan
Shimizu, Shizuoka, Japan
Tokyo, , Japan
Onga Gun, Fukuoka, Japan
Takamatsu Shi, Kagawa, Japan
Nagasaki Shi, Nagasaki, Japan
Ageo, Saitama, Japan
Sizuoka Shi, Shizuoka, Japan
Himeji, , Japan
Saga, , Japan
Nagoya, Aichi, Japan
Kitakyushu, Fukuoka, Japan
Itami, Hyogo, Japan
Ono, Hyogo, Japan
Odawara Shi, Kanagawa, Japan
Sagamihara Shi, Kanagawa, Japan
Shibuya, Tokyo, Japan
Patients applied
Trial Officials
ABBVIE INC.
Study Director
AbbVie
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported