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CompletedNCT05609643SELECT AXIS RWUpdated Sep 2, 2026

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

An observational study in Ankylosing Spondylitis, sponsored by AbbVie. Completed at 61 sites in Japan. Per ClinicalTrials.gov, last updated 2026-09-02.

Sponsored by AbbVie · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
69
Sex
All
01

Study 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.

02

Conditions studied

  • Ankylosing Spondylitis

Keywords

  • Ankylosing Spondylitis
  • RINVOQ
03

In context

Spondylitis, Ankylosing

498 studies on the registry are indexed under Spondylitis, Ankylosing; 89 are open to participants now.

This study's enrollment of 69 is below the median of 200 across 210 observational studies indexed under Spondylitis, Ankylosing.

Browse Spondylitis, Ankylosing studies →

Lead sponsor

AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.

Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult participants with Ankylosing Spondylitis (AS)

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
69 participants (actual)

Groups and cohorts

  • Rinvoq

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

06

What researchers measure

Primary outcomes

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

    Incidence of serious drug related adverse reactions will be assessed.

    Time frame: Up to 52 Weeks

07

Study locations

61 sites
  • Kurotsuchi Orthopaedic Clinic /ID# 251076
    Kasugashi, Aichi-ken 8160849, Japan
  • Japan Organization of Occupational Health and Safety Chubu Rosai Hospital /ID# 258201
    Nagoya, Aichi-ken 455-8530, Japan
  • Nagoya University Hospital /ID# 254435
    Nagoya, Aichi-ken 466-8560, Japan
  • Fujita Health University Hospital /ID# 258204
    Toyoake, Aichi-ken 470-1192, Japan
  • Tomita Clinic /ID# 251075
    Kashiwa-shi, Chiba 277-0005, Japan
  • Noda Hospital /ID# 254429
    Noda, Chiba 270-0237, Japan
  • Yamada Rheumatology Clinic /ID# 264182
    Matsuyama, Ehime 564-0062, Japan
  • Matsuyama Red Cross Hospital /ID# 261974
    Matsuyama, Ehime 790-8524, Japan
  • Yagi Hospital - Fukuoka /ID# 251078
    Fukuoka, Fukuoka 812-0054, Japan
  • Kunou Orthopedic Clinic /ID# 252168
    Kitakyushu-shi, Fukuoka 800-0206, Japan
  • Hospital Of The University Of Occupational And Environmental Health, Japan /ID# 252570
    Kitakyushu-shi, Fukuoka 807-8556, Japan
  • Zaitsu Orthopedics Clinic /ID# 256998
    Onojo-shi, Fukuoka 816-0952, Japan
  • Inoue Hospital /ID# 261959
    Takasaki-shi, Gunma 370-0053, Japan
  • National Hospital Organization Asahikawa Medical Center /ID# 268282
    Asahikawa, Hokkaido 070-0901, Japan
  • Katayama Orthopedic Rheumatology Clinic /ID# 251071
    Asahikawa-shi, Hokkaido 078-8243, Japan
  • Sapporo Rheumatology and immunology clinic /ID# 256175
    Sapporo, Hokkaido 060-0807, Japan
  • Hokkaido University Hospital /ID# 258203
    Sapporo, Hokkaido 060-8648, Japan
  • Himeji Medical Center /ID# 255197
    Himeji-shi, Hyōgo 670-8520, Japan
  • Kobe Kaisei Hospital /ID# 251073
    Kobe, Hyōgo 657-0068, Japan
  • Hyogo Medical University Hospital /ID# 253200
    Nishinomiya-shi, Hyōgo 663-8501, Japan
  • Clinic Quest For Rheumatology & Well Being /ID# 268817
    Mito, Ibaraki 310-0015, Japan
  • Kanazawa University Hospital /ID# 252170
    Kanazawa, Ishikawa-ken 920-8641, Japan
  • Sanuki Municipal Hospital /ID# 251104
    Sanuki-shi, Kagawa-ken 769-2393, Japan
  • Kagoshima University Hospital /ID# 256997
    Kagoshima, Kagoshima-ken 890-8520, Japan
  • Toranomon Hospital Kajigaya /ID# 260158
    Kawasaki-shi, Kanagawa 213-8587, Japan
  • Takahashi Clinic /ID# 252924
    Kawasaki-shi, Kanagawa 216-0033, Japan
  • Kitasato University Hospital /ID# 254480
    Sagamihara-shi, Kanagawa 252-0375, Japan
  • Sakuragicho Yokohama Clinic /ID# 266671
    Yokohama, Kanagawa 231-0063, Japan
  • Yokohama City University Medical Center /ID# 258149
    Yokohama, Kanagawa 232-0024, Japan
  • Yokohama Minami Kyousai Hosp /ID# 252172
    Yokohama, Kanagawa 236-0037, Japan
  • Kyoto Okamoto Memorial Hospital /ID# 255153
    Kuse-gun, Kyoto 613-0034, Japan
  • Kyoto University Hospital /ID# 261970
    Kyoto, Kyoto 606-8507, Japan
  • Chiyoda Hospital /ID# 251077
    Hyuga-shi, Miyazaki 883-0064, Japan
  • National Hospital Organization Miyakonojo Medical Center /ID# 268280
    Miyakonojō, Miyazaki 885-0014, Japan
  • University of Miyazaki Hospital /ID# 266669
    Miyazaki, Miyazaki 889-1692, Japan
  • Yoshida Internal Medicine Clinic - Sakaki /ID# 268285
    Sakaki, Nagano 389-0606, Japan
  • Sasebo Chuo Hospital /ID# 253202
    Sasebo-shi, Nagasaki 857-1195, Japan
  • Nagasaki Kita Hospital /ID# 266672
    Togitsu, Nagasaki 851-2103, Japan
  • Tenri Hospital /ID# 256996
    Tenri-shi, Nara 632-8552, Japan
  • National Hospital Organization Osaka Minami Medical Center /ID# 251072
    Kawachinagano Shi, Osaka 586-8521, Japan
  • Kinshukai Infusion Clinic /ID# 251070
    Osaka, Osaka 530-0011, Japan
  • Osaka City General Hospital /ID# 258202
    Osaka, Osaka 534-0021, Japan
  • Osaka Metropolitan University Hospital /ID# 254436
    Osaka, Osaka 545-8586, Japan
  • Osaka Medical and Pharmaceutical University Hospital /ID# 260159
    Takatsuki-shi, Osaka 569-8686, Japan
  • Koga Community Hospital /ID# 251074
    Yaizu, Shizuoka 425-0088, Japan
  • Dokkyo Medical University Hospital /ID# 270947
    Mibu, Tochigi 321-0293, Japan
  • Anan Medical Center /ID# 268818
    Anan-shi, Tokushima 774-0045, Japan
  • Nishiogu RA Clinic /ID# 266670
    Arakawa-ku, Tokyo 116-0011, Japan
  • Juntendo University Hospital /ID# 251103
    Bunkyo-ku, Tokyo 113-8431, Japan
  • Institute of Science Tokyo Hospital /ID# 252569
    Bunkyo-ku, Tokyo 113-8519, Japan
  • Suzuki Clinic Orthopaedics River City /ID# 254482
    Chuo-ku, Tokyo 104-0051, Japan
  • National Hospital Organization Tokyo Medical Center /ID# 270441
    Meguro-ku, Tokyo 152-8902, Japan
  • Showa University East Hospital /ID# 267448
    Shinagawa, Tokyo 142-0054, Japan
  • Meiyo Immunology & Rheumatology Clinic /ID# 256176
    Suginami -ku, Tokyo 167-0042, Japan
  • 500koku Orthopedic Clinic /ID# 268283
    Nakaniikawa-gun, Toyama 930-0214, Japan
  • Takaoka Rheumatic Orthopedic Clinic /ID# 252895
    Takaoka-shi, Toyama 933-0874, Japan
  • Toyama University Hospital /ID# 251682
    Toyama, Toyama 930-0194, Japan
  • Kasugai Clinic /ID# 253201
    Fuefuki-shi, Yamanashi 4060002, Japan
  • Nippon Life Saiseikai Public Interest Foundation Nippon Life Hospital /ID# 252166
    Osaka, 550-0006, Japan
  • Maeshima Rheumatology Clinic /ID# 251079
    Ōita, 870-0823, Japan
  • Toyama Hospital /ID# 268281
    Toyama, 939-8511, Japan
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05609643
Lead sponsor
AbbVie
Responsible party
Sponsor
First posted
Nov 8, 2022
Start date
Jul 6, 2022
Primary completion
Dec 11, 2025
Completion
Jan 29, 2026
Last update
Sep 2, 2026

Study contacts

ABBVIE INC.
study director · AbbVie

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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