Assessing the effectiveness of Rinvoq for ankylosing spondylitis in Japan

A Study to Evaluate Safety and Effectiveness of RINVOQ in Adult Participants With Ankylosing Spondylitis in the Real-World Japan (SELECT AXIS RW)

This study is testing how well Rinvoq works for adults with ankylosing spondylitis in Japan over a year of regular treatment.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Sex: All
• Sponsor: AbbVie (Industry-sponsored)
• Drugs / interventions: upadacitinib
• Locations: 58 sites (Kasugashi, Aichi and 57 other locations)
• Trial ID: NCT05609643 on ClinicalTrials.gov

What this trial studies

This observational study evaluates the real-world effectiveness of Rinvoq in treating adult patients with ankylosing spondylitis (AS) in Japan. Approximately 100 participants who have been prescribed Rinvoq will be enrolled and followed for up to 52 weeks. The study aims to assess changes in disease activity and any adverse events associated with the treatment, based on routine clinical practice without imposing additional burdens on participants. Regular visits will be conducted at participating hospitals or clinics as per standard care.

Who should consider this trial

Good fit: Ideal candidates are adults diagnosed with ankylosing spondylitis who are starting treatment with Rinvoq.

Not a fit: Patients who have previously been treated with JAK inhibitors or those for whom Rinvoq is contraindicated may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the real-world effectiveness of Rinvoq for managing ankylosing spondylitis.

How similar studies have performed: Other studies have shown positive outcomes with similar treatments for ankylosing spondylitis, indicating a potential for success in this approach.

Eligibility criteria

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.

Where this trial is running

Kasugashi, Aichi and 57 other locations

• Kurotsuchi Orthopaedic Clinic /ID# 251076 — Kasugashi, Aichi, Japan (Recruiting)
• Japan Organization of Occupational Health and Safety Chubu Rosai Hospital /ID# 258201 — Nagoya-shi, Aichi, Japan (Recruiting)
• Nagoya University Hospital /ID# 254435 — Nagoya-shi, Aichi, Japan (Recruiting)
• Fujita Health University Hospital /ID# 258204 — Toyoake, Aichi, Japan (Recruiting)
• Tomita Clinic /ID# 251075 — Kashiwa-shi, Chiba, Japan (Recruiting)
• Yamada Rheumatology Clinic /ID# 264182 — Matsuyama-shi, Ehime, Japan (Recruiting)
• Matsuyama Red Cross Hospital /ID# 261974 — Matsuyama-shi, Ehime, Japan (Recruiting)
• Noda Hospital /ID# 254429 — Noda-shi, Fukui, Japan (Recruiting)
• Toyama Hospital /ID# 268281 — Toyama, Fukui, Japan (Recruiting)
• Yagi Hospital /ID# 251078 — Fukuoka-shi, Fukuoka, Japan (Recruiting)
• Kunou Orthopedic Clinic /ID# 252168 — Kitakyushu-shi, Fukuoka, Japan (Recruiting)
• Hospital of the University of Occupational and Environmental Health, Japan /ID# 252570 — Kitakyushu-shi, Fukuoka, Japan (Recruiting)
• Inoue Hospital /ID# 261959 — Takasaki-shi, Gunma, Japan (Recruiting)
• Katayama Orthopedic Rheumatology Clinic /ID# 251071 — Asahikawa-shi, Hokkaido, Japan (Recruiting)
• National Hospital Organization Asahikawa Medical Center /ID# 268282 — Asahikawa, Hokkaido, Japan (Recruiting)
• Sapporo Rheumatology and immunology clinic /ID# 256175 — Sapporo-shi, Hokkaido, Japan (Recruiting)
• Hokkaido University Hospital /ID# 258203 — Sapporo-shi, Hokkaido, Japan (Recruiting)
• Himeji Medical Center /ID# 255197 — Himeji-shi, Hyogo, Japan (Recruiting)
• Kobe Kaisei Hospital /ID# 251073 — Kobe-shi, Hyogo, Japan (Recruiting)
• Hyogo Medical University Hospital /ID# 253200 — Nishinomiya-shi, Hyogo, Japan (Recruiting)
• Clinic Quest For Rheumatology & Well-being /ID# 268817 — 水戸市, Ibaraki, Japan (Recruiting)
• Kanazawa University Hospital /ID# 252170 — Kanazawa-shi, Ishikawa, Japan (Recruiting)
• Sanuki Municipal Hospital /ID# 251104 — Sanuki-shi, Kagawa, Japan (Recruiting)
• Kagoshima University Hospital /ID# 256997 — Kagoshima-shi, Kagoshima, Japan (Recruiting)
• Toranomon Hospital Kajigaya /ID# 260158 — Kawasaki-shi, Kanagawa, Japan (Recruiting)
• Takahashi Clinic /ID# 252924 — Kawasaki-shi, Kanagawa, Japan (Recruiting)
• Kitasato University Hospital /ID# 254480 — Sagamihara-shi, Kanagawa, Japan (Recruiting)
• Yokohama City University Medical Center /ID# 258149 — Yokohama shi, Kanagawa, Japan (Recruiting)
• Sakuragicho Yokohama Clinic /ID# 266671 — Yokohama-shi, Kanagawa, Japan (Recruiting)
• Yokohama Minami Kyousai Hosp /ID# 252172 — Yokohama-shi, Kanagawa, Japan (Recruiting)
• Kyoto Okamoto Memorial Hospital /ID# 255153 — Kuse District, Kyoto, Japan (Recruiting)
• Kyoto University Hospital /ID# 261970 — Kyoto-shi, Kyoto, Japan (Recruiting)
• Chiyoda Hospital /ID# 251077 — Hyuga-shi, Miyazaki, Japan (Recruiting)
• National Hospital Organization Miyakonojo Medical Center /ID# 268280 — Miyakonojo, Miyazaki, Japan (Recruiting)
• Yoshida Internal Medicine Clinic - Sakaki /ID# 268285 — Sakaki, Nagano, Japan (Recruiting)
• Nagasaki Kita Hospital /ID# 266672 — Nishisonogi-gun, Nagasaki, Japan (Recruiting)
• Sasebo Chuo Hospital /ID# 253202 — Sasebo-shi, Nagasaki, Japan (Recruiting)
• Tenri Hospital /ID# 256996 — Tenri-shi, Nara, Japan (Recruiting)
• Oribe Clinic of Rheumatism and Medicine /ID# 251079 — Oita-shi, Oita, Japan (Recruiting)
• National Hospital Organization Osaka Minami Medical Center /ID# 251072 — Kawachinagano Shi, Osaka, Japan (Recruiting)
• Kinshukai Infusion Clinic /ID# 251070 — Osaka-shi, Osaka, Japan (Recruiting)
• Osaka City General Hospital /ID# 258202 — Osaka-shi, Osaka, Japan (Recruiting)
• Osaka Metropolitan University Hospital /ID# 254436 — Osaka-shi, Osaka, Japan (Recruiting)
• Nippon Life Saiseikai Public Interest Foundation Nippon Life Hospital /ID# 252166 — Osaka-shi, Osaka, Japan (Recruiting)
• Osaka Medical and Pharmaceutical University Hospital /ID# 260159 — Takatsuki-shi, Osaka, Japan (Recruiting)
• Koga Community Hospital /ID# 251074 — Yaizu City, Shizuoka, Japan (Recruiting)
• Anan Medical Center /ID# 268818 — Anan-shi, Tokushima, Japan (Recruiting)
• Juntendo University Hospital /ID# 251103 — Bunkyo-ku, Tokyo, Japan (Recruiting)
• Tokyo Medical And Dental University Hospital /ID# 252569 — Bunkyo-ku, Tokyo, Japan (Recruiting)
• Suzuki Clinic Orthopaedics River City /ID# 254482 — Chuo-ku, Tokyo, Japan (Recruiting)

Study contacts

• Study coordinator: AbbVie GK Clinical Trial Registration Desk

Conditions Ankylosing Spondylitis; RINVOQ