NCT02202850

Defining Remission With Etanercept in AS in Real Life Clinical Practice

Defining Which Remission Criterion At Month 6 Predicts Remission At Month 12 In A Real Life Clinical Practice, In A Cohort Of Ankylosing Spondylitis Patients Treated With Etanercept (Enbrel (Registered))

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 84 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Determine which remission criterion at Month 6 predicts remission at Month 12 the best.

Detailed description

The analysis of the primary endpoint will be based on a logistic regression defining the dependent variable as the remission at Month 12 and the 6 independent variables as ASAS partial remission, ASAS 5/6, ASAS60, ASAS40, BASDAI50 and ASDAS inactive disease status. This analysis will be conducted in each arm of the study as well as after a pooling of both patient groups. In this context it seems reasonable to ensure the completion of the study by a total approximate number of 100 patients (approximately 50 patients per arm). In order to ensure 50 completers in each arm, 70 patients will be recruited at baseline, taking into account a drop-out rate of 30% over 1 year period.

Conditions

• Ankylosing Spondylitis

Interventions

Type	Name	Description
DRUG	etanercept	etanercept 1 x 50 mg/week or 2 x 25mg/week
DRUG	etanercept	etanercept 1 x 50 mg/week or 2 x 25mg/week

Timeline

• Start date: 2014-08-12
• Primary completion: 2017-04-26
• Completion: 2017-04-26
• First posted: 2014-07-29
• Last updated: 2018-11-30
• Results posted: 2018-11-30

Locations

29 sites across 1 country: Belgium