NCT01079182

Basic Documentation of Adalimumab (Humira) in Patients With Ankylosing Spondylitis (AS)

Safety and Effectiveness of Adalimumab in Patients With Ankylosing Spondylitis in Routine Clinical Practice

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 4,681 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The research question explored in this study was whether the effectiveness and safety of adalimumab in participants with ankylosing spondylitis was maintained during long-term therapy in routine clinical practice in Germany.

Detailed description

This was a postmarketing observational study (PMOS) for participants with insufficiently controlled, moderate to severe, active AS who were eligible for adalimumab therapy. Participants started treatment with adalimumab under normal clinical settings in Germany. Enrolled participants were followed during adalimumab therapy . Participants were assessed during regular clinic visits for up to 24 months and 359 clinicians (rheumatologists/orthopedists/general practitioners/internist) participated in the study. Since this was an observational trial, not all doctors followed the stated age limitations and some participants under the age of 18 were enrolled.

Conditions

• Ankylosing Spondylitis

Timeline

• Start date: 2006-01-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2010-03-03
• Last updated: 2015-07-09
• Results posted: 2015-06-01