NCT06112665

ToFAcitinib in Early Active Axial SpondyloarThritis:

ToFAcitinib in Early Active Axial SpondyloarThritis: a Prospective, Randomized, Double-BLind, PlAcebo-CoNtrolled MulticEntre Study

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: Charite University, Berlin, Germany · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Axial Spondyloarthritis

Interventions

Type	Name	Description
DRUG	Tofacitinib 5 MG	Patients receive Tofacitinib and Naproxene

Timeline

• Start date: 2023-11-10
• Primary completion: 2025-03-01
• Completion: 2026-06-01
• First posted: 2023-11-01
• Last updated: 2024-11-26

Locations

1 site across 1 country: Germany