ToFAcitinib in Early Active Axial SpondyloarThritis:
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tofacitinib 5 MG.
- Who it may be relevant to
- Registry conditions: Axial Spondyloarthritis. Basic parameters: 18 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
ToFAcitinib in Early Active Axial SpondyloarThritis: a Prospective, Randomized, Double-BLind, PlAcebo-CoNtrolled MulticEntre Study
Overview
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.
Interventions
- Drug Tofacitinib 5 MG
Patients receive Tofacitinib and Naproxene
Primary outcome measures
- Main trial endpoint [Time frame: 16 weeks]
Secondary outcome measures (1)
- Change from baseline in the MRI SIJ SPARCC osteitis score at week 16 [Time frame: 16 weeks]
Eligibility criteria
Inclusion criteria
- Clinical diagnosis of axSpA and fulfilment of the ASAS classification criteria
- Symptom (back pain) duration for ≤ 2 years, according to the definition of early axial SpA by ASAS.
- Active disease activity as defined by: BASDAI ≥4 and back pain score (BASDAI question 2) of ≥4 AND objective signs of inflammation evident by osteitis in MRI of SIJ AND/OR elevated serum CRP levels.
Exclusion criteria
- active current infection, severe infections in the last 3 months
- history of recurrent Herpes zoster or disseminated Herpes simplex
- immunodeficiency
- chronic Hepatitis B, C or HIV infection
- women: pregnant or lactating (have to practice reliable method of contraception)
- other severe diseases conflicting with a clinical study, contraindications for MRI
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Germany · 1 center
- Charité Universitätsmedizin Berlin — Berlin
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: 10.1177/1759720X2 PMID 40078463
Identifiers
NCT: NCT06112665 · FASTLANE1