ToFAcitinib in Early Active Axial SpondyloarThritis:

NCT06112665 · tracked via the Priya Life Science Germany tracker

Sponsor

Charite University, Berlin, Germany

Phase

Phase 4

Started

2023-11-10

Last updated

2024-11-26

Condition(s) studied

Axial Spondyloarthritis

Investigational drug(s) / intervention(s)

Tofacitinib 5 MG →

Tofacitinib 5 MG: Patients receive Tofacitinib and Naproxene

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

45 Years

Healthy volunteers

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

Primary outcome measure(s)

Main trial endpoint — 16 weeks
Proportion of subjects achieving disease remission defined as Ankylosing Spondylitis Disease Activity Score (ASDAS)CRP\<1.3 at week 16 from baseline

Trial sites (1)

Facility	City	Region	Status
Charité Universitätsmedizin Berlin	Berlin	Germany	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06112665 on ClinicalTrials.gov ↗ ← All trials in Germany