Study Evaluating Etanercept Treatment of Patients With Ankylosing Spondylitis
The primary objective of the study was to compare the efficacy of etanercept (25 mg, twice weekly) with that of placebo based on the percentage of patients who achieve the Assessment in Ankylosing Spondylitis (ASAS) response criteria (ASAS 20%) at week 12.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Multicenter, Double-Blind, Parallel, Placebo-Controlled, Randomised Phase 3 Study of Etanercept in the Treatment of Patients With Ankylosing Spondylitis: 12-Week Final Data|
- To compare the efficacy of etanercept (25 mg, twice weekly) with that of placebo based on the
- percentage of patients who achieved the assessment in Ankylosing Spondylitis (ASAS 20%) response criteria at week 12.
- To assess: 1) the safety of etanercept in this patient population; 2) the efficacy of etanercept
- compared with that of placebo using the ASAS response criteria at 50% and 70% levels at week 12.
|Study Start Date:||March 2002|
|Estimated Study Completion Date:||August 2002|