Secukinumab in Active Rheumatoid Arthritis after Anti-TNFα Therapy: A Randomized, Double-Blind Placebo-Controlled Phase 3 Study.

ABSTRACT:

Introduction

'REASSURE' (NCT01377012), a phase 3 study, evaluated the efficacy and safety of secukinumab in patients with active rheumatoid arthritis (RA) who had an inadequate response to, or intolerance of, tumor necrosis factor inhibitors (TNF-inhibitors).

Methods

A total of 637 patients were randomized (1:1:1) to receive intravenous secukinumab 10 mg/kg (baseline, weeks 2 and 4) followed by subcutaneous secukinumab 150 mg or 75 mg every 4 weeks (starting from week 8) or placebo at the same dosing schedule. The primary endpoint was the American College of Rheumatology 20% improvement criteria (ACR20) at week 24. Other predefined hierarchical endpoints included Health Assessment Questionnaire-Disability Index, van der Heijde modified total Sharp score (vdH-mTSS) at week 24

SUBMITTER: Tahir H 

PROVIDER: S-EPMC5696298 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature