Tofacitinib in early active axial spondyloarthritis: protocol of a randomized double-blind, placebo-controlled, multicenter phase IV study, FASTLANE.

ABSTRACT:

Background

Early treatment initiation is one of the strongest predictors of good treatment response in axial spondyloarthritis (axSpA). Recently, the Assessment in SpondyloArthritis International Society (ASAS) defined early axSpA as a diagnosis of axSpA with a duration of axial symptoms equal to or less than 2 years. Tofacitinib is a Janus kinase (JAK) inhibitor for the treatment of ankylosing spondylitis.

Objectives

Compare the efficacy and safety of tofacitinib versus placebo (both on non-steroidal anti-inflammatory drug (NSAID) background) in patients with active early axSpA and inadequate response to at least one NSAID.

Design

This is a phase IV, randomized, double-blind, placebo-controlled, multicenter clinical trial.

Methods and analysis

The study will r

SUBMITTER: Rios Rodriguez V 

PROVIDER: S-EPMC11898075 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature