The purpose of this study objective will be to evaluate the efficacy and safety of etanercept 50 mg BIW in RA subjects who showed a sub-optimal response to standard dose etanercept (50 mg QW) and concomitant methotrexate therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
200
Proportion of subjects achieving a good or moderate DAS28 response (as defined by the EULAR28 response criteria) at Week 12
Proportion of subjects who achieve American College of Rheumatology (ACR) 20, 50, and 70 responses at Weeks 12 and 24
Proportion of subjects achieving a good or moderate DAS28 response (as defined by the EULAR28 response criteria at Week 24 and the proportion achieving clinical remission (DAS28<2.6) at Weeks 12 and 24
Changes from baseline with respect to the DAS28 score and ACR score (including HAQ) criteria at Weeks 12 and 24
Changes from baseline in patient-reported outcomes as measured by the SF-36 at Weeks 12 and 24
Proportion of etanercept 50mg BIW responders at Week 12 who mantain a clinical improvement with etanercept 50mg QW (defined as no DAS28 increase of greater than 0.6 from Week 12) at Week 24
Safety (SAEs and AEs) in three study periods (4-week open label run-in period, 12-week double blinded period A, and 12-week open-label period B)
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