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

AbbVie

Status: Completed

Conditions: Ankylosing Spondylitis

Study type: Observational

Funder types: Industry

Identifiers

NCT05609643

P22-963

Details and patient eligibility

About

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.

Enrollment: 69 patients

Sex: All

Volunteers: No 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.

Trial design

69 participants in 1 patient group

Rinvoq

Description:

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