ToFAcitinib in Early Active Axial SpondyloarThritis:

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-10

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Axial Spondyloarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

multicentre, randomized, double-blind, placebo-controlled study

Study Groups

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Tofactinib

Patients receive Tofacitinib and Naproxene

Group Type EXPERIMENTAL

Tofacitinib 5 MG

Intervention Type DRUG

Patients receive Tofacitinib and Naproxene

Placebo Arm

Patients receive placebo pills and Naproxene

Group Type ACTIVE_COMPARATOR

Tofacitinib 5 MG

Intervention Type DRUG

Patients receive Tofacitinib and Naproxene

Interventions

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Tofacitinib 5 MG

Patients receive Tofacitinib and Naproxene

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No