Ankylosing Spondylitis Clinical Trial
Official title:
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))
Determine which remission criterion at Month 6 predicts remission at Month 12 the best.
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.
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