NCT01754727

Impact of Adalimumab (Humira®) Therapy on Selected Health Care Resource Utilization and Sick Leave in Patients With Ankylosing Spondylitis in Clinical Practice

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 452 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to assess the proportion of AS patients achieving treatment response to adalimumab therapy.

Detailed description

This post-marketing observational study (PMOS) was performed in a multi-country, multi-center, single-arm format. Data were collected prospectively and retrospectively. Adult patients with diagnosis of AS who were assigned for treatment with adalimumab (Humira®) were eligible for participation. Each patient included in this study was to be observed during his/her adalimumab treatment for a maximum of 12 month period. During this period four follow-up visits were planned for observation of the patient and documentation of data. Ideally, these visits should have been performed approximately 3 (V1), 6 (V2), 9 (V3) and 12 (V4) months after the baseline visit (V0).

Conditions

• Ankylosing Spondylitis

Timeline

• Start date: 2012-12-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2012-12-21
• Last updated: 2017-03-06
• Results posted: 2017-03-06