ToFAcitinib in Early Active Axial SpondyloarThritis:

Study Overview
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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.

Official Title
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ToFAcitinib in Early Active Axial SpondyloarThritis: a Prospective, Randomized, Double-BLind, PlAcebo-CoNtrolled MulticEntre Study

Conditions
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Axial Spondyloarthritis

Intervention / Treatment
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* Drug: Tofacitinib 5 MG


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tofactinib<br>Patients receive Tofacitinib and Naproxene | Drug: Tofacitinib 5 MG<br>* Patients receive Tofacitinib and Naproxene<br>|
| Active Comparator: Placebo Arm<br>Patients receive placebo pills and Naproxene | Drug: Tofacitinib 5 MG<br>* Patients receive Tofacitinib and Naproxene<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the MRI SIJ SPARCC osteitis score at week 16 | Change from baseline in the MRI SIJ SPARCC osteitis score at week 16 | 16 weeks |