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Ankylosing SpondylitisSELECT AXIS RWNCT05609643

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 of Ankylosing Spondylitis, run by AbbVie at 61 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Ankylosing Spondylitis
How many people
69 participants
Where
61 sitesJapan
Study dates
6 Jul 2022to 29 Jan 2026
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Adult participants with Ankylosing Spondylitis (AS)

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

61 sites in 1 country.

61 sites in 1 country

Japan61 sites

  • Anan Medical Center /ID# 268818

    Anan-shi, Tokushima, 774-0045

  • Nishiogu RA Clinic /ID# 266670

    Arakawa-ku, Tokyo, 116-0011

  • National Hospital Organization Asahikawa Medical Center /ID# 268282

    Asahikawa, Hokkaido, 070-0901

  • Katayama Orthopedic Rheumatology Clinic /ID# 251071

    Asahikawa-shi, Hokkaido, 078-8243

  • Juntendo University Hospital /ID# 251103

    Bunkyo-ku, Tokyo, 113-8431

  • Institute of Science Tokyo Hospital /ID# 252569

    Bunkyo-ku, Tokyo, 113-8519

  • Suzuki Clinic Orthopaedics River City /ID# 254482

    Chuo-ku, Tokyo, 104-0051

  • Kasugai Clinic /ID# 253201

    Fuefuki-shi, Yamanashi, 4060002

  • Yagi Hospital - Fukuoka /ID# 251078

    Fukuoka, Fukuoka, 812-0054

  • Himeji Medical Center /ID# 255197

    Himeji-shi, Hyōgo, 670-8520

  • Chiyoda Hospital /ID# 251077

    Hyuga-shi, Miyazaki, 883-0064

  • Kagoshima University Hospital /ID# 256997

    Kagoshima, Kagoshima-ken, 890-8520

  • Kanazawa University Hospital /ID# 252170

    Kanazawa, Ishikawa-ken, 920-8641

  • Tomita Clinic /ID# 251075

    Kashiwa-shi, Chiba, 277-0005

  • Kurotsuchi Orthopaedic Clinic /ID# 251076

    Kasugashi, Aichi-ken, 8160849

  • National Hospital Organization Osaka Minami Medical Center /ID# 251072

    Kawachinagano Shi, Osaka, 586-8521

  • Toranomon Hospital Kajigaya /ID# 260158

    Kawasaki-shi, Kanagawa, 213-8587

  • Takahashi Clinic /ID# 252924

    Kawasaki-shi, Kanagawa, 216-0033

  • Kunou Orthopedic Clinic /ID# 252168

    Kitakyushu-shi, Fukuoka, 800-0206

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

    Kitakyushu-shi, Fukuoka, 807-8556

  • Kobe Kaisei Hospital /ID# 251073

    Kobe, Hyōgo, 657-0068

  • Kyoto Okamoto Memorial Hospital /ID# 255153

    Kuse-gun, Kyoto, 613-0034

  • Kyoto University Hospital /ID# 261970

    Kyoto, Kyoto, 606-8507

  • Yamada Rheumatology Clinic /ID# 264182

    Matsuyama, Ehime, 564-0062

  • Matsuyama Red Cross Hospital /ID# 261974

    Matsuyama, Ehime, 790-8524

  • National Hospital Organization Tokyo Medical Center /ID# 270441

    Meguro-ku, Tokyo, 152-8902

  • Dokkyo Medical University Hospital /ID# 270947

    Mibu, Tochigi, 321-0293

  • Clinic Quest For Rheumatology & Well Being /ID# 268817

    Mito, Ibaraki, 310-0015

  • National Hospital Organization Miyakonojo Medical Center /ID# 268280

    Miyakonojō, Miyazaki, 885-0014

  • University of Miyazaki Hospital /ID# 266669

    Miyazaki, Miyazaki, 889-1692

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

    Nagoya, Aichi-ken, 455-8530

  • Nagoya University Hospital /ID# 254435

    Nagoya, Aichi-ken, 466-8560

  • 500koku Orthopedic Clinic /ID# 268283

    Nakaniikawa-gun, Toyama, 930-0214

  • Hyogo Medical University Hospital /ID# 253200

    Nishinomiya-shi, Hyōgo, 663-8501

  • Noda Hospital /ID# 254429

    Noda, Chiba, 270-0237

  • Maeshima Rheumatology Clinic /ID# 251079

    Ōita, 870-0823

  • Zaitsu Orthopedics Clinic /ID# 256998

    Onojo-shi, Fukuoka, 816-0952

  • Kinshukai Infusion Clinic /ID# 251070

    Osaka, Osaka, 530-0011

  • Osaka City General Hospital /ID# 258202

    Osaka, Osaka, 534-0021

  • Osaka Metropolitan University Hospital /ID# 254436

    Osaka, Osaka, 545-8586

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

    Osaka, 550-0006

  • Kitasato University Hospital /ID# 254480

    Sagamihara-shi, Kanagawa, 252-0375

  • Yoshida Internal Medicine Clinic - Sakaki /ID# 268285

    Sakaki, Nagano, 389-0606

  • Sanuki Municipal Hospital /ID# 251104

    Sanuki-shi, Kagawa-ken, 769-2393

  • Sapporo Rheumatology and immunology clinic /ID# 256175

    Sapporo, Hokkaido, 060-0807

  • Hokkaido University Hospital /ID# 258203

    Sapporo, Hokkaido, 060-8648

  • Sasebo Chuo Hospital /ID# 253202

    Sasebo-shi, Nagasaki, 857-1195

  • Showa University East Hospital /ID# 267448

    Shinagawa, Tokyo, 142-0054

  • Meiyo Immunology & Rheumatology Clinic /ID# 256176

    Suginami -ku, Tokyo, 167-0042

  • Takaoka Rheumatic Orthopedic Clinic /ID# 252895

    Takaoka-shi, Toyama, 933-0874

  • Inoue Hospital /ID# 261959

    Takasaki-shi, Gunma, 370-0053

  • Osaka Medical and Pharmaceutical University Hospital /ID# 260159

    Takatsuki-shi, Osaka, 569-8686

  • Tenri Hospital /ID# 256996

    Tenri-shi, Nara, 632-8552

  • Nagasaki Kita Hospital /ID# 266672

    Togitsu, Nagasaki, 851-2103

  • Toyama University Hospital /ID# 251682

    Toyama, Toyama, 930-0194

  • Toyama Hospital /ID# 268281

    Toyama, 939-8511

  • Fujita Health University Hospital /ID# 258204

    Toyoake, Aichi-ken, 470-1192

  • Koga Community Hospital /ID# 251074

    Yaizu, Shizuoka, 425-0088

  • Sakuragicho Yokohama Clinic /ID# 266671

    Yokohama, Kanagawa, 231-0063

  • Yokohama City University Medical Center /ID# 258149

    Yokohama, Kanagawa, 232-0024

  • Yokohama Minami Kyousai Hosp /ID# 252172

    Yokohama, Kanagawa, 236-0037

Other trials in Japan

About this study

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

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.

Read more

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.

Keywords
Ankylosing Spondylitis, RINVOQ
Medical subject headings
Spondylitis, Ankylosing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05609643
Study groupRoleWhat they receive
RinvoqParticipants will receive Rinvoq as prescribed by their physician according to local label.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Incidence of serious drug related adverse reactions will be assessed.

    Measured: Up to 52 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2022
  2. Study start6 Jul 2022
  3. Primary completion11 Dec 2025
  4. Study completion29 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
69 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05609643
Sponsor's protocol ID
P22-963
Acronym
SELECT AXIS RW
Status last verified
Aug 2026
First submitted
7 Nov 2022
Last updated
2 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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