Study to Assess Change in Disease Activity and Adverse Events of RINVOQ in Adult Participants With Ankylosing Spondylitis in the Real-World Japan
- Conditions
- Ankylosing Spondylitis
- Registration Number
- NCT05609643
- Lead Sponsor
- AbbVie
- Brief Summary
Axial spondyloarthritis (axSpA), which encompasses radiographic axSpA (r-axSpA, also known as ankylosing spondylitis \[AS\]) is an immune-mediated inflammatory disease primarily affecting the axial skeleton. This study will assess how effective Rinvoq is in treating axSpA.
Rinvoq is an approved drug for treating axSpA. Approximately 100 adult participants who are prescribed Rinvoq by their physician in accordance with local label will be enrolled in Japan.
Participants will receive Rinvoq as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 52 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- Participant with clinical diagnosis of ankylosing spondylitis (AS) and meeting the modified New York Criteria for AS.
- Participant who is administered the first dose of Rinvoq for AS.
- Participant with prior treatment by JAK inhibitors.
- Participant currently participating in another clinical study except non-interventional study.
- Participant for whom upadacitinib is contraindicated.
- Participants who are not registered within 14 days after initiation of Rinvoq treatment for AS.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence Percentage of Serious Infection as Adverse Drug Reactions ( ADR) Up to 52 Weeks Incidence of serious drug related adverse reactions will be assessed.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (58)
Yagi Hospital /ID# 251078
🇯🇵Fukuoka-shi, Fukuoka, Japan
Kunou Orthopedic Clinic /ID# 252168
🇯🇵Kitakyushu-shi, Fukuoka, Japan
Kobe Kaisei Hospital /ID# 251073
🇯🇵Kobe-shi, Hyogo, Japan
Kagoshima University Hospital /ID# 256997
🇯🇵Kagoshima-shi, Kagoshima, Japan
Takahashi Clinic /ID# 252924
🇯🇵Kawasaki-shi, Kanagawa, Japan
Sanuki Municipal Hospital /ID# 251104
🇯🇵Sanuki-shi, Kagawa, Japan
Kitasato University Hospital /ID# 254480
🇯🇵Sagamihara-shi, Kanagawa, Japan
Noda Hospital /ID# 254429
🇯🇵Noda-shi, Fukui, Japan
National Hospital Organization Miyakonojo Medical Center /ID# 268280
🇯🇵Miyakonojo, Miyazaki, Japan
Anan Medical Center /ID# 268818
🇯🇵Anan-shi, Tokushima, Japan
Juntendo University Hospital /ID# 251103
🇯🇵Bunkyo-ku, Tokyo, Japan
National Hospital Organization Tokyo Medical Center /ID# 270441
🇯🇵Meguro, Tokyo, Japan
Toranomon Hospital Kajigaya /ID# 260158
🇯🇵Kawasaki-shi, Kanagawa, Japan
Chiyoda Hospital /ID# 251077
🇯🇵Hyuga-shi, Miyazaki, Japan
National Hospital Organization Osaka Minami Medical Center /ID# 251072
🇯🇵Kawachinagano Shi, Osaka, Japan
Takaoka Rheumatic Orthopedic Clinic /ID# 252895
🇯🇵Takaoka-shi, Toyama, Japan
Katayama Orthopedic Rheumatology Clinic /ID# 251071
🇯🇵Asahikawa-shi, Hokkaido, Japan
Nagasaki Kita Hospital /ID# 266672
🇯🇵Nishisonogi-gun, Nagasaki, Japan
Nippon Life Saiseikai Public Interest Foundation Nippon Life Hospital /ID# 252166
🇯🇵Osaka-shi, Osaka, Japan
University of Miyazaki Hospital /ID# 266669
🇯🇵Miyazaki, Japan
Kurotsuchi Orthopaedic Clinic /ID# 251076
🇯🇵Kasugashi, Aichi, Japan
Japan Organization of Occupational Health and Safety Chubu Rosai Hospital /ID# 258201
🇯🇵Nagoya-shi, Aichi, Japan
Nagoya University Hospital /ID# 254435
🇯🇵Nagoya-shi, Aichi, Japan
Fujita Health University Hospital /ID# 258204
🇯🇵Toyoake, Aichi, Japan
Tomita Clinic /ID# 251075
🇯🇵Kashiwa-shi, Chiba, Japan
Yamada Rheumatology Clinic /ID# 264182
🇯🇵Matsuyama-shi, Ehime, Japan
Matsuyama Red Cross Hospital /ID# 261974
🇯🇵Matsuyama-shi, Ehime, Japan
Toyama Hospital /ID# 268281
🇯🇵Toyama, Fukui, Japan
Inoue Hospital /ID# 261959
🇯🇵Takasaki-shi, Gunma, Japan
Hospital of the University of Occupational and Environmental Health, Japan /ID# 252570
🇯🇵Kitakyushu-shi, Fukuoka, Japan
National Hospital Organization Asahikawa Medical Center /ID# 268282
🇯🇵Asahikawa, Hokkaido, Japan
Sapporo Rheumatology and immunology clinic /ID# 256175
🇯🇵Sapporo-shi, Hokkaido, Japan
Hokkaido University Hospital /ID# 258203
🇯🇵Sapporo-shi, Hokkaido, Japan
Himeji Medical Center /ID# 255197
🇯🇵Himeji-shi, Hyogo, Japan
Clinic Quest For Rheumatology & Well-being /ID# 268817
🇯🇵水戸市, Ibaraki, Japan
Hyogo Medical University Hospital /ID# 253200
🇯🇵Nishinomiya-shi, Hyogo, Japan
Kanazawa University Hospital /ID# 252170
🇯🇵Kanazawa-shi, Ishikawa, Japan
Yokohama City University Medical Center /ID# 258149
🇯🇵Yokohama shi, Kanagawa, Japan
Sakuragicho Yokohama Clinic /ID# 266671
🇯🇵Yokohama-shi, Kanagawa, Japan
Yokohama Minami Kyousai Hosp /ID# 252172
🇯🇵Yokohama-shi, Kanagawa, Japan
Kyoto Okamoto Memorial Hospital /ID# 255153
🇯🇵Kuse District, Kyoto, Japan
Kyoto University Hospital /ID# 261970
🇯🇵Kyoto-shi, Kyoto, Japan
Yoshida Internal Medicine Clinic - Sakaki /ID# 268285
🇯🇵Sakaki, Nagano, Japan
Sasebo Chuo Hospital /ID# 253202
🇯🇵Sasebo-shi, Nagasaki, Japan
Oribe Clinic of Rheumatism and Medicine /ID# 251079
🇯🇵Oita-shi, Oita, Japan
Tenri Hospital /ID# 256996
🇯🇵Tenri-shi, Nara, Japan
Kinshukai Infusion Clinic /ID# 251070
🇯🇵Osaka-shi, Osaka, Japan
Osaka City General Hospital /ID# 258202
🇯🇵Osaka-shi, Osaka, Japan
Osaka Metropolitan University Hospital /ID# 254436
🇯🇵Osaka-shi, Osaka, Japan
Osaka Medical and Pharmaceutical University Hospital /ID# 260159
🇯🇵Takatsuki-shi, Osaka, Japan
Koga Community Hospital /ID# 251074
🇯🇵Yaizu City, Shizuoka, Japan
Tokyo Medical And Dental University Hospital /ID# 252569
🇯🇵Bunkyo-ku, Tokyo, Japan
Suzuki Clinic Orthopaedics River City /ID# 254482
🇯🇵Chuo-ku, Tokyo, Japan
Meiyo Immunology & Rheumatology Clinic /ID# 256176
🇯🇵Suginami -ku, Tokyo, Japan
Nishiogu Clinic /ID# 266670
🇯🇵荒川区, Tokyo, Japan
500koku Orthopedic Clinic /ID# 268283
🇯🇵Nakaniikawa-gun, Toyama, Japan
Toyama University Hospital /ID# 251682
🇯🇵Toyama-shi, Toyama, Japan
Kasugai Clinic /ID# 253201
🇯🇵Fuefuki-shi, Yamanashi, Japan