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ToFAcitinib in Early Active Axial SpondyloarThritis:

Name: ToFAcitinib in Early Active Axial SpondyloarThritis: — clinical trial record (NCT06112665)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Study acronym: FASTLANE

StatusRecruiting

PhasePhase 4

SponsorCharite University, Berlin, Germany

Started2023-11-10

View on ClinicalTrials.gov ↗

Record status

This record was last updated November 26, 2024 (before its estimated March 2025 completion). Its status may not reflect the trial's current state.

Amendment history

2024-11-22

Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1

Trial statusNot Yet Recruiting→Recruiting

Primary completion date2025-11-30→2025-03

Completion date2026-02-28→2026-06

Study sites0→1

2023-10-29

Original filing

Charite University, Berlin, Germany

132 trials monitored

See 2 trials at risk

Ankylosing Spondylitis

176 trials monitored

See 6 trials at risk

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.

Trial Details

NCT Number	NCT06112665
Lead Sponsor	Charite University, Berlin, Germany Collaborators: Pfizer
Conditions	Axial Spondyloarthritis
Enrollment	104 participants
Start Date	2023-11-10
Primary Completion	2025-03 (estimated)
Study Completion	2026-06 (estimated)
Updated on ClinicalTrials.gov	2024-11-26