Cyclophosphamide and Azathioprine vs Tacrolimus in Antisynthetase Syndrome-related Interstitial Lung Disease
Status:
Recruiting
Trial end date:
2024-01-02
Target enrollment:
Participant gender:
Summary
"Antisynthetase syndrome (ASS) is one of the most severe inflammatory myopathy (IM), due to
pulmonary involvement (interstitial lung disease, ILD). Until now, the most commonly used
immunosuppresive therapy in Europe is Cyclophosphamide followed by different
immunosuppressive drugs as maintenance therapy, including Azathioprine (and so called "
European Strategy "). In the USA however, the first-line immunosuppressive treatment is
Tacrolimus (so called " American Strategy "). None of these two different strategies has ever
been studied prospectively, and there is no clear comparison of short and long-term treatment
efficacy and tolerance. Thus, there are yet no evidences helping the clinicians in the
therapeutic management of patients with ASS-related ILD.
The aim of this study is therefore to compare both strategies as first line treatments or in
relapsing patients : CATR.PAT study is a 52 weeks, randomized, comparative, controlled,
open-labeled, phase III, therapeutic clinical trial, comparing two treatment strategies."