ToFAcitinib in Early Active Axial SpondyloarThritis:

Phase 4

Recruiting

• Conditions: Axial Spondyloarthritis
• Interventions: Drug: Tofacitinib 5 MG

• Registration Number: NCT06112665
• Lead Sponsor: Charite University, Berlin, Germany

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-29
• Study First Submitted QC: 2023-10-29
• Study First Posted: 2023-11-01
• Study Start: 2023-11-10
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-22
• Last Update Posted: 2024-11-26
• Primary Completion: 2025-03
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 104

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tofactinib	Tofacitinib 5 MG	Patients receive Tofacitinib and Naproxene
Placebo Arm	Tofacitinib 5 MG	Patients receive placebo pills and Naproxene

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Change from baseline in the MRI SIJ SPARCC osteitis score at week 16	16 weeks	Change from baseline in the MRI SIJ SPARCC osteitis score at week 16

Trial Locations

Locations (1)

Charité Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany