ToFAcitinib in Early Active Axial SpondyloarThritis:

Sponsor
Charite University, Berlin, Germany
Study ID
NCT06112665
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Nov 10, 2023
Status verified
Nov 2024
Primary completion
Mar 31, 2025
Completion
Jun 30, 2026

Study Design

Enrollment
104 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tofactinib
    Patients receive Tofacitinib and Naproxene
  • Active Comparator: Placebo Arm
    Patients receive placebo pills and Naproxene

Primary Outcome Measure

Main trial endpoint [ Time Frame: 16 weeks ]

Central Contacts

Related Studies