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

Recruiting

• Conditions: Ankylosing Spondylitis

• Registration Number: NCT05609643
• Lead Sponsor: AbbVie

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-06
• Study First Submitted: 2022-11-07
• Study First Submitted QC: 2022-11-07
• Study First Posted: 2022-11-08
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-16
• Last Update Posted: 2024-08-19
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (58)

Kurotsuchi Orthopaedic Clinic /ID# 251076; 🇯🇵 Kasugashi, Aichi, Japan

Japan Organization of Occupational Health and Safety Chubu Rosai Hospital /ID# 258201; 🇯🇵 Nagoya-shi, Aichi, Japan

Nagoya University Hospital /ID# 254435; 🇯🇵 Nagoya-shi, Aichi, Japan

Fujita Health University Hospital /ID# 258204; 🇯🇵 Toyoake, Aichi, Japan

Tomita Clinic /ID# 251075; 🇯🇵 Kashiwa-shi, Chiba, Japan

Yamada Rheumatology Clinic /ID# 264182; 🇯🇵 Matsuyama-shi, Ehime, Japan

Matsuyama Red Cross Hospital /ID# 261974; 🇯🇵 Matsuyama-shi, Ehime, Japan

Noda Hospital /ID# 254429; 🇯🇵 Noda-shi, Fukui, Japan

Toyama Hospital /ID# 268281; 🇯🇵 Toyama, Fukui, Japan

Yagi Hospital /ID# 251078; 🇯🇵 Fukuoka-shi, Fukuoka, Japan

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