biostudies-literatureUnknown17Rios Rodriguez V<h4>Background</h4>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.<h4>Objectives</h4>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.<h4>Design</h4>This is a phase IV, randomized, double-blind, placebo-controlled, multicenter clinical trial.<h4>Methods and analysis</h4>The study will rTherapeutic advances in musculoskeletal disease1759720X251324429https://www.ebi.ac.uk/biostudies/studies/S-EPMC11898075biostudies-literatureTofacitinib in early active axial spondyloarthritis: protocol of a randomized double-blind, placebo-controlled, multicenter phase IV study, FASTLANE.PMC11898075Sanchez-Riera LProft FTorgutalp MRios Rodriguez VBinder EZhao YHoppner CMundayat RDiehl AHaibel HYndestad ARademacher JVranic IPoddubnyy DfalseTofacitinib in early active axial spondyloarthritis: protocol of a randomized double-blind, placebo-controlled, multicenter phase IV study, FASTLANE.<h4>Background</h4>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.<h4>Objectives</h4>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.<h4>Design</h4>This is a phase IV, randomized, double-blind, placebo-controlled, multicenter clinical trial.<h4>Methods and analysis</h4>The study will r2025-01-01T00:00:00Z20252026-06-02T21:04:58.749Z2025-04-04T01:29:04.766ZS-EPMC118980754007846310.1177/1759720X251324429