Secukinumab Efficacy and Safety Study in Patients With Rheumatoid Arthritis and Inadequate Response to Anti-TNFα Agents.

Phase 3 Terminated 242 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupDouble-blindTreatment

Summary

This study will provide efficacy and safety data of the secukinumab pre-filled syringe (PFS) for subcutaneous self-administration in patients with active rheumatoid arthritis who are intolerant to or have had an inadequate response to anti-TNF-α agents.

Timeline

Start: 2012-10
Primary completion: 2015-05
Completion: 2015-05

Outcome

Missed primary endpoint

registry AIN457 75 mg vs Placebo; p = 0.2001; Odds Ratio (OR) 1.55 (95% CI 0.79 to 3.03); Regression, Logistic NCT01770379 ↗

registry AIN457 150mg vs Placebo; p = 0.1574; Odds Ratio (OR) 1.62 (95% CI 0.83 to 3.15); Regression, Logistic NCT01770379 ↗

Publications

Huang Y, Fan Y, Liu Y, Xie W, Zhang Z. Efficacy and safety of secukinumab in active rheumatoid arthritis with an inadequate response to tumor necrosis factor inhibitors: a meta-analysis of phase III randomized controlled trials. Clin Rheumatol. 2019 Oct;38(10):2765-2776. doi: 10.1007/s10067-019-04595-1. Epub 2019 May 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Secukinumab	Monoclonal antibody	75 mg	Subcutaneous
Subject	Secukinumab	Monoclonal antibody	150 mg	Subcutaneous