NCT00900796

Study Evaluating Predictors of Response in Patients With Ankylosing Spondylitis

Success and Failure of Biological Therapy: Predictors of Response in Patients With Active Ankylosing Spondylitis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 132 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this observational study is to determine the incidence of response in patients with predictive factors of major clinical response in active ankylosing spondylitis (AS) in patients who start anti-tumor necrosis factor (anti-TNF) therapy and correlate these findings in patients who switch from one to another anti-TNF due to inefficacy under usual clinical practice conditions in Spain.

Detailed description

A sample size of 240 patients, 120 of them exposed and 120 not exposed to factors of response. Sample will be obtain from all the consecutive patients attending the rheumatology settings included in the study who fulfill the inclusion criteria

Conditions

• Ankylosing Spondylitis

Interventions

Type	Name	Description
OTHER	Treatment switching	If the patients do not response to first AntiTNF treatment, Investigator can switch to another anti TNF.Spanish Guidelines will be provided to the investigators, which recommend stopping biologics if there is an inadequate response after 16w of therapy and switch to another biologic. Responsive patients to the first anti-TNF who continue with this first anti-TNF adjusting dose treatment according to the Spanish guidelines or investigator criteria. The doses for each Anti TNF will be done following specific SmPc and under Investiagtor criteria

Timeline

• Start date: 2009-03-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2009-05-13
• Last updated: 2012-06-19
• Results posted: 2012-06-19

Locations

1 site across 1 country: Spain