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

IF 3.4 2区 医学 Q2 RHEUMATOLOGY
Therapeutic Advances in Musculoskeletal Disease Pub Date : 2025-03-12 eCollection Date: 2025-01-01 DOI:10.1177/1759720X251324429
Valeria Rios Rodriguez, Lidia Sánchez-Riera, Hildrun Haibel, Caroline Höppner, Murat Torgutalp, Fabian Proft, Judith Rademacher, Elke Binder, Annette Diehl, Ivana Vranic, Yuxi Zhao, Rajiv Mundayat, Arne Yndestad, Denis Poddubnyy
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引用次数: 0

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 recruit 104 patients aged ⩾18 and ⩽45 years with active early axSpA (chronic back pain ⩽2 years), inadequate response to at least one NSAID, and objective signs of active inflammation (on magnetic resonance imaging (MRI) of sacroiliac joints (SIJs) or elevated C-reactive protein). Patients will be randomized 1:1 to receive tofacitinib 5 mg twice daily or placebo, with background naproxen 500 mg twice daily for 16 weeks. Patients not meeting early treatment response criteria at week 4 will receive open-label tofacitinib until week 16. Primary and key secondary endpoints at week 16 will be the proportion of patients achieving disease remission (Axial Spondyloarthritis Disease Activity Score <1.3) and change from baseline in MRI SIJ Spondyloarthritis Research Consortium of Canada osteitis score, respectively. Safety will be monitored up to 4 weeks after the last study drug dose.

Ethics: The study will be performed according to the ethical principles of the Declaration of Helsinki and will be approved by independent ethics committees of each center.

Discussion: This is one of the first randomized clinical trials designed to evaluate the efficacy and safety of a JAK inhibitor in the recently ASAS-defined "early" axSpA population. Trial registration: ClinicalTrials.gov: NCT06112665; CTIS: 2023-505050-18-00.

托法替尼治疗早期活动性轴性脊柱关节炎:随机双盲、安慰剂对照、多中心 IV 期研究 FASTLANE 的方案。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
6.80
自引率
4.80%
发文量
132
审稿时长
18 weeks
期刊介绍: Therapeutic Advances in Musculoskeletal Disease delivers the highest quality peer-reviewed articles, reviews, and scholarly comment on pioneering efforts and innovative studies across all areas of musculoskeletal disease.
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