Study to Assess Change in Disease Activity and Adverse Events of RINVOQ in Adult Participants With Ankylosing Spondylitis in the Real-World Japan

NCT05609643 | Completed

• 1 other identifier: P22-963
• Study Type: observational
• Target: 69
• Locations: 1 country
• Sites: 61

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.

Conditions

Ankylosing Spondylitis

Keywords

Ankylosing Spondylitis; RINVOQ

Outcome Measures

Primary Outcomes (1)

• Incidence Percentage of Serious Infection as Adverse Drug Reactions ( ADR)

  Incidence of serious drug related adverse reactions will be assessed.

  Up to 52 Weeks

Study Arms (1)

Rinvoq

Participants will receive Rinvoq as prescribed by their physician according to local label.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants with Ankylosing Spondylitis (AS)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (61)

Kurotsuchi Orthopaedic Clinic /ID# 251076

Kasugashi, Aichi-ken, 8160849, Japan

Location

Japan Organization of Occupational Health and Safety Chubu Rosai Hospital /ID# 258201

Nagoya, Aichi-ken, 455-8530, Japan

Location

Nagoya University Hospital /ID# 254435

Nagoya, Aichi-ken, 466-8560, Japan

Location

Fujita Health University Hospital /ID# 258204

Toyoake, Aichi-ken, 470-1192, Japan

Location

Tomita Clinic /ID# 251075

Kashiwa-shi, Chiba, 277-0005, Japan

Location

Noda Hospital /ID# 254429

Noda, Chiba, 270-0237, Japan

Location

Yamada Rheumatology Clinic /ID# 264182

Matsuyama, Ehime, 564-0062, Japan

Location

Matsuyama Red Cross Hospital /ID# 261974

Matsuyama, Ehime, 790-8524, Japan

Location

Yagi Hospital - Fukuoka /ID# 251078

Fukuoka, Fukuoka, 812-0054, Japan

Location

Kunou Orthopedic Clinic /ID# 252168

Kitakyushu-shi, Fukuoka, 800-0206, Japan

Location

Hospital Of The University Of Occupational And Environmental Health, Japan /ID# 252570

Kitakyushu-shi, Fukuoka, 807-8556, Japan

Location

Zaitsu Orthopedics Clinic /ID# 256998

Onojo-shi, Fukuoka, 816-0952, Japan

Location

Inoue Hospital /ID# 261959

Takasaki-shi, Gunma, 370-0053, Japan

Location

National Hospital Organization Asahikawa Medical Center /ID# 268282

Asahikawa, Hokkaido, 070-0901, Japan

Location

Katayama Orthopedic Rheumatology Clinic /ID# 251071

Asahikawa-shi, Hokkaido, 078-8243, Japan

Location

Sapporo Rheumatology and immunology clinic /ID# 256175

Sapporo, Hokkaido, 060-0807, Japan

Location

Hokkaido University Hospital /ID# 258203

Sapporo, Hokkaido, 060-8648, Japan

Location

Himeji Medical Center /ID# 255197

Himeji-shi, Hyōgo, 670-8520, Japan

Location

Kobe Kaisei Hospital /ID# 251073

Kobe, Hyōgo, 657-0068, Japan

Location

Hyogo Medical University Hospital /ID# 253200

Nishinomiya-shi, Hyōgo, 663-8501, Japan

Location

Clinic Quest For Rheumatology & Well Being /ID# 268817

Mito, Ibaraki, 310-0015, Japan

Location

Kanazawa University Hospital /ID# 252170

Kanazawa, Ishikawa-ken, 920-8641, Japan

Location

Sanuki Municipal Hospital /ID# 251104

Sanuki-shi, Kagawa-ken, 769-2393, Japan

Location

Kagoshima University Hospital /ID# 256997

Kagoshima, Kagoshima-ken, 890-8520, Japan

Location

Toranomon Hospital Kajigaya /ID# 260158

Kawasaki-shi, Kanagawa, 213-8587, Japan

Location

Takahashi Clinic /ID# 252924

Kawasaki-shi, Kanagawa, 216-0033, Japan

Location

Kitasato University Hospital /ID# 254480

Sagamihara-shi, Kanagawa, 252-0375, Japan

Location

Sakuragicho Yokohama Clinic /ID# 266671

Yokohama, Kanagawa, 231-0063, Japan

Location

Yokohama City University Medical Center /ID# 258149

Yokohama, Kanagawa, 232-0024, Japan

Location

Yokohama Minami Kyousai Hosp /ID# 252172

Yokohama, Kanagawa, 236-0037, Japan

Location

Kyoto Okamoto Memorial Hospital /ID# 255153

Kuse-gun, Kyoto, 613-0034, Japan

Location

Kyoto University Hospital /ID# 261970

Kyoto, Kyoto, 606-8507, Japan

Location

Chiyoda Hospital /ID# 251077

Hyuga-shi, Miyazaki, 883-0064, Japan

Location

National Hospital Organization Miyakonojo Medical Center /ID# 268280

Miyakonojō, Miyazaki, 885-0014, Japan

Location

University of Miyazaki Hospital /ID# 266669

Miyazaki, Miyazaki, 889-1692, Japan

Location

Yoshida Internal Medicine Clinic - Sakaki /ID# 268285

Sakaki, Nagano, 389-0606, Japan

Location

Sasebo Chuo Hospital /ID# 253202

Sasebo-shi, Nagasaki, 857-1195, Japan

Location

Nagasaki Kita Hospital /ID# 266672

Togitsu, Nagasaki, 851-2103, Japan

Location

Tenri Hospital /ID# 256996

Tenri-shi, Nara, 632-8552, Japan

Location

National Hospital Organization Osaka Minami Medical Center /ID# 251072

Kawachinagano Shi, Osaka, 586-8521, Japan

Location

Kinshukai Infusion Clinic /ID# 251070

Osaka, Osaka, 530-0011, Japan

Location

Osaka City General Hospital /ID# 258202

Osaka, Osaka, 534-0021, Japan

Location

Osaka Metropolitan University Hospital /ID# 254436

Osaka, Osaka, 545-8586, Japan

Location

Osaka Medical and Pharmaceutical University Hospital /ID# 260159

Takatsuki-shi, Osaka, 569-8686, Japan

Location

Koga Community Hospital /ID# 251074

Yaizu, Shizuoka, 425-0088, Japan

Location

Dokkyo Medical University Hospital /ID# 270947

Mibu, Tochigi, 321-0293, Japan

Location

Anan Medical Center /ID# 268818

Anan-shi, Tokushima, 774-0045, Japan

Location

Nishiogu RA Clinic /ID# 266670

Arakawa-ku, Tokyo, 116-0011, Japan

Location

Juntendo University Hospital /ID# 251103

Bunkyo-ku, Tokyo, 113-8431, Japan

Location

Institute of Science Tokyo Hospital /ID# 252569

Bunkyo-ku, Tokyo, 113-8519, Japan

Location

Suzuki Clinic Orthopaedics River City /ID# 254482

Chuo-ku, Tokyo, 104-0051, Japan

Location

National Hospital Organization Tokyo Medical Center /ID# 270441

Meguro-ku, Tokyo, 152-8902, Japan

Location

Showa University East Hospital /ID# 267448

Shinagawa, Tokyo, 142-0054, Japan

Location

Meiyo Immunology & Rheumatology Clinic /ID# 256176

Suginami -ku, Tokyo, 167-0042, Japan

Location

500koku Orthopedic Clinic /ID# 268283

Nakaniikawa-gun, Toyama, 930-0214, Japan

Location

Takaoka Rheumatic Orthopedic Clinic /ID# 252895

Takaoka-shi, Toyama, 933-0874, Japan

Location

Toyama University Hospital /ID# 251682

Toyama, Toyama, 930-0194, Japan

Location

Kasugai Clinic /ID# 253201

Fuefuki-shi, Yamanashi, 4060002, Japan

Location

Nippon Life Saiseikai Public Interest Foundation Nippon Life Hospital /ID# 252166

Osaka, 550-0006, Japan

Location

Maeshima Rheumatology Clinic /ID# 251079

Ōita, 870-0823, Japan

Location

Toyama Hospital /ID# 268281

Toyama, 939-8511, Japan

Location

Related Links

• Related info

MeSH Terms

Conditions

Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 8, 2022
• Study Start: July 6, 2022
• Primary Completion: December 11, 2025
• Study Completion: January 29, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

JP (61)