ToFAcitinib in Early Active Axial SpondyloarThritis:

Phase 4RecruitingNCT06112665

Charite University, Berlin, Germany104 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

104

Conditions

Axial Spondyloarthritis

Interventions

Tofacitinib 5 MGDRUG

Patients receive Tofacitinib and Naproxene

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

Charité Universitätsmedizin Berlin

Berlin, Germany

RECRUITING

Outcomes

Primary Outcomes

Main trial endpoint

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

Time frame: 16 weeks

Secondary Outcomes

Change from baseline in the MRI SIJ SPARCC osteitis score at week 16

Time frame: 16 weeks

Central Contacts

Hildrun Haibel, PD Dr. med.

CONTACT

+49308445 hildrun.haibel@charite.de

Valeria Rios-Rodriguez, Dr. med.

CONTACT

+30450 valeria.rios-rodriguez@charite.de

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.