Ankylosing Spondylitis Clinical Trial
— SELECT AXIS RWOfficial title:
A Study to Evaluate Safety and Effectiveness of RINVOQ in Adult Participants With Ankylosing Spondylitis in the Real-World Japan (SELECT AXIS RW)
| NCT number | NCT05609643 |
| Other study ID # | P22-963 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | July 6, 2022 |
| Est. completion date | December 31, 2025 |
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.
| Status | Recruiting |
| Enrollment | 100 |
| Est. completion date | December 31, 2025 |
| Est. primary completion date | December 31, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
| Country | Name | City | State |
|---|---|---|---|
| Japan | Nishiogu Clinic /ID# 266670 | ??? | Tokyo |
| Japan | Katayama Orthopedic Rheumatology Clinic /ID# 251071 | Asahikawa-shi | Hokkaido |
| Japan | Juntendo University Hospital /ID# 251103 | Bunkyo-ku | Tokyo |
| Japan | Tokyo Medical And Dental University Hospital /ID# 252569 | Bunkyo-ku | Tokyo |
| Japan | Suzuki Clinic Orthopaedics River City /ID# 254482 | Chuo-ku | Tokyo |
| Japan | Kasugai Clinic /ID# 253201 | Fuefuki-shi | Yamanashi |
| Japan | Yagi Hospital /ID# 251078 | Fukuoka-shi | Fukuoka |
| Japan | Himeji Medical Center /ID# 255197 | Himeji-shi | Hyogo |
| Japan | Chiyoda Hospital /ID# 251077 | Hyuga-shi | Miyazaki |
| Japan | Kagoshima University Hospital /ID# 256997 | Kagoshima-shi | Kagoshima |
| Japan | Kanazawa University Hospital /ID# 252170 | Kanazawa-shi | Ishikawa |
| Japan | Tomita Clinic /ID# 251075 | Kashiwa-shi | Chiba |
| Japan | Kurotsuchi Orthopaedic Clinic /ID# 251076 | Kasugashi | Aichi |
| Japan | National Hospital Organization Osaka Minami Medical Center /ID# 251072 | Kawachinagano Shi | Osaka |
| Japan | Takahashi Clinic /ID# 252924 | Kawasaki-shi | Kanagawa |
| Japan | Toranomon Hospital Kajigaya /ID# 260158 | Kawasaki-shi | Kanagawa |
| Japan | Hospital of the University of Occupational and Environmental Health, Japan /ID# 252570 | Kitakyushu-shi | Fukuoka |
| Japan | Kunou Orthopedic Clinic /ID# 252168 | Kitakyushu-shi | Fukuoka |
| Japan | Kobe Kaisei Hospital /ID# 251073 | Kobe-shi | Hyogo |
| Japan | Kyoto Okamoto Memorial Hospital /ID# 255153 | Kuse District | Kyoto |
| Japan | Kyoto University Hospital /ID# 261970 | Kyoto-shi | Kyoto |
| Japan | Matsuyama Red Cross Hospital /ID# 261974 | Matsuyama-shi | Ehime |
| Japan | Yamada Rheumatology Clinic /ID# 264182 | Matsuyama-shi | Ehime |
| 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 | 500koku Orthopedic Clinic /ID# 268283 | Nakaniikawa-gun | Toyama |
| Japan | Hyogo Medical University Hospital /ID# 253200 | Nishinomiya-shi | Hyogo |
| Japan | Nagasaki Kita Hospital /ID# 266672 | Nishisonogi-gun | Nagasaki |
| Japan | Noda Hospital /ID# 254429 | Noda-shi | |
| Japan | Oribe Clinic of Rheumatism and Medicine /ID# 251079 | Oita-shi | Oita |
| Japan | Kinshukai Infusion Clinic /ID# 251070 | Osaka-shi | Osaka |
| Japan | Nippon Life Saiseikai Public Interest Foundation Nippon Life Hospital /ID# 252166 | Osaka-shi | Osaka |
| Japan | Osaka City General Hospital /ID# 258202 | Osaka-shi | Osaka |
| Japan | Osaka Metropolitan University Hospital /ID# 254436 | Osaka-shi | Osaka |
| Japan | Kitasato University Hospital /ID# 254480 | Sagamihara-shi | Kanagawa |
| Japan | Sanuki Municipal Hospital /ID# 251104 | Sanuki-shi | Kagawa |
| Japan | Hokkaido University Hospital /ID# 258203 | Sapporo-shi | Hokkaido |
| Japan | Sapporo Rheumatology and immunology clinic /ID# 256175 | Sapporo-shi | Hokkaido |
| Japan | Sasebo Chuo Hospital /ID# 253202 | Sasebo-shi | Nagasaki |
| Japan | Meiyo Immunology & Rheumatology Clinic /ID# 256176 | Suginami -ku | Tokyo |
| Japan | Takaoka Rheumatic Orthopedic Clinic /ID# 252895 | Takaoka-shi | Toyama |
| Japan | Inoue Hospital /ID# 261959 | Takasaki-shi | Gunma |
| Japan | Osaka Medical and Pharmaceutical University Hospital /ID# 260159 | Takatsuki-shi | Osaka |
| Japan | Tenri Hospital /ID# 256996 | Tenri-shi | Nara |
| Japan | Toyama University Hospital /ID# 251682 | Toyama-shi | Toyama |
| Japan | Fujita Health University Hospital /ID# 258204 | Toyoake | Aichi |
| Japan | Koga Community Hospital /ID# 251074 | Yaizu City | Shizuoka |
| Japan | Yokohama City University Medical Center /ID# 258149 | Yokohama shi | Kanagawa |
| Japan | Yokohama Minami Kyousai Hosp /ID# 252172 | Yokohama-shi | Kanagawa |
| Lead Sponsor | Collaborator |
|---|---|
| AbbVie |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence Percentage of Serious Infection as Adverse Drug Reactions ( ADR) | Incidence of serious drug related adverse reactions will be assessed. | Up to 52 Weeks |
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