ToFAcitinib in Early Active Axial SpondyloarThritis:

Summary

This is a phase IV, multicentre, randomized, double-blind, placebo-controlled study designed to compare the efficacy and safety of tofacitinib versus placebo (on a background of an NSAID) over 16 weeks of treatment and 4 weeks of safety follow-up in subjects with early active axSpA and inadequate response to at least one NSAID, with objective signs of inflammation.

Timeline

Start

2023-11-10

Primary completion

2025-03

Completion

2026-06

Publications

• Rios Rodriguez V, Sanchez-Riera L, Haibel H, Hoppner C, Torgutalp M, Proft F, Rademacher J, Binder E, Diehl A, Vranic I, Zhao Y, Mundayat R, Yndestad A, Poddubnyy D. Tofacitinib in early active axial spondyloarthritis: protocol of a randomized double-blind, placebo-controlled, multicenter phase IV study, FASTLANE. Ther Adv Musculoskelet Dis. 2025 Mar 12;17:1759720X251324429. doi: 10.1177/1759720X251324429. eCollection 2025.

Drugs

Indications