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ToFAcitinib in Early Active Axial SpondyloarThritis:

NCT06112665 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2024-11-26

No results posted yet for this study

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

DRUG

Tofacitinib 5 MG

Patients receive Tofacitinib and Naproxene

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Charite University, Berlin, Germany

    lead OTHER

Principal Investigators

  • Denis Poddubbnyy, Prof. Dr. med. · Charité Rheumatology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-10
Primary Completion
2025-03-31
Completion
2026-06-30

Countries

  • Germany

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06112665 on ClinicalTrials.gov