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NCT Number: NCT05609643

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

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Kurotsuchi Orthopaedic Clinic /ID# 251076, Kasugashi, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: Up to 52 Weeks

    Incidence of serious drug related adverse reactions will be assessed.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Acronym: SELECT AXIS RW

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Nov 8, 2022
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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