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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05609643

Acronym

SELECT AXIS RW

Enrollment

Registered

2022-11-08

Start date

2022-07-06

Completion date

2026-01-29

Last updated

2026-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankylosing Spondylitis

Keywords

Ankylosing Spondylitis, RINVOQ

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Incidence Percentage of Serious Infection as Adverse Drug Reactions ( ADR)	Up to 52 Weeks	Incidence of serious drug related adverse reactions will be assessed.

Countries

Japan

Contacts

STUDY_DIRECTORABBVIE INC.

AbbVie

Outcome results