ToFAcitinib in Early Active Axial SpondyloarThritis:

ConditionAxial Spondyloarthritis

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18-45

SponsorCharite University, Berlin, Germany

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Tofacitinib 5 MG
Drug
Patients receive Tofacitinib and Naproxene

Treatment groups

104 Participants

are divided into 2 treatment groups

Group A: TofactinibExperimental treatment 1 intervention

Group B: Placebo ArmActive comparator 1 intervention

Trial 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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Charite University, Berlin, Germany

Lead sponsor

Pfizer

Collaborator

Source ClinicalTrials.gov

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