NCT01474876

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

Multicountry Post-Marketing Observational Study on Maintenance of Effectiveness of Adalimumab in Patients With Ankylosing Spondylitis and Psoriatic Arthritis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 566 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This 12-month postmarketing observational study (PMOS) was a prospective, single-arm, multicenter, multi-country study, with follow-up visits at 3, 6, 9, and 12 months after the initial baseline visit. The study was conducted to determine the long-term effectiveness of treatment with adalimumab in routine clinical use in participants with Ankylosing Spondylitis (AS) and Psoriatic Arthritis (PsA) in Central and Eastern European Countries.

Detailed description

Additional study objectives were to evaluate AS and PsA with regard to extra-articular manifestations (EAMs), functional status, the use of concomitant nonsteroidal anti-inflammatory medication, and work productivity impairment. In addition, the Ankylosing Spondylitis Disease Activity Score (ASDAS), a new disease activity index in AS, was measured in parallel with the standard Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score to assess the effectiveness of adalimumab in treating axial symptoms.

Conditions

• Ankylosing Spondylitis
• Psoriatic Arthritis

Timeline

• Start date: 2011-11-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2011-11-18
• Last updated: 2015-07-08
• Results posted: 2015-07-08