Trial Information

Official Title: Multi-country Post-Marketing Observational Study on Maintenance of Effectiveness of Adalimumab (Humira®) in Patients With Ankylosing Spondylitis and Psoriatic Arthritis

Summary

There is a need to evaluate the current diagnostic and treatment practices in Ankylosing Spondylitis (AS) and Psoriatic Arthritis (PsA) in Central and Eastern European Countries, with special focus on the use of conventional disease modifying antirheumatic drugs (DMARDs) and biologic agents. Further, it is necessary to establish the long-term clinical outcomes of adalimumab therapy in routine clinical practice, in particular its sustained effectiveness, impact on extra-articular manifestations (EAMs), co-medication with Nonsteroidal anti-inflammatory drugs (NSAIDs) and work productivity. Ankylosing Spondylitis Disease Activity Score (ASDAS), a new disease activity index in Ankylosing Spondylitis (AS), is not yet widely used in routine clinical practice, and there is a lack of clinical data in Ankylosing Spondylitis (AS) (and Psoriatic Arthritis (PsA)) patients on adalimumab therapy, employing Ankylosing Spondylitis Disease Activity Score (ASDAS) as an outcome measure, particularly in comparison with the standard Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score. Ankylosing Spondylitis Disease Activity Score (ASDAS) score will be calculated by the sponsor based on the data recorded otherwise during this Postmarketing observational study (PMOS).

Phase: N/A

Sponsor: AbbVie (prior sponsor, Abbott)

Overall Contacts:

Kresimir Furkovic, MD
+385 1 2350 531
kresimir.furkovic@abbott.com

Jonathan Moller, MD
Phone: Tel: +61 (02) 9384 9710
jonathan.moller@abbvie.com