NCT03770663: CATR-PAT

Cyclophosphamide and Azathioprine vs Tacrolimus in Antisynthetase Syndrome-related Interstitial Lung Disease

Status unknown Phase 3 Last updated 9 February 2021

What this trial tests

Phase 3 trial testing Cyclophosphamide and azathioprine in Antisynthetase Syndrome (ASS) in 76 participants. Status unknown.

Timeline

5 February 2021

Primary endpoint
2 January 2024

2 January 2024

Quick facts

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	76
Start date	5 February 2021
Primary completion	2 January 2024
Estimated completion	2 January 2024
Sites	1 location across France

Drugs / interventions tested

• Cyclophosphamide and azathioprine — full drug profile →
• Tacrolimus (TACROLIMUS) — full drug profile →

Conditions studied

• Antisynthetase Syndrome (ASS) — all drugs for Antisynthetase Syndrome (ASS) →
• Interstitial Lung Disease — all drugs for Interstitial Lung Disease →

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

18 and older, any sex, with Antisynthetase Syndrome (ASS) or Interstitial Lung Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

"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."

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Role of Macrophages in Connective Tissue Disease-Associated Interstitial Lung Disease: Focusing on Molecular Mechanisms and Potential Treatment Strategies.
   Tseng CC, Sung YW, Chen KY, Wang PY, et al · · 2023 · cited 15× · PMID 37569370 · DOI 10.3390/ijms241511995
2. Progression in the Management of Non-Idiopathic Pulmonary Fibrosis Interstitial Lung Diseases, Where Are We Now and Where We Would Like to Be.
   Goos T, De Sadeleer LJ, Yserbyt J, Verleden GM, et al · · 2021 · cited 11× · PMID 33807034 · DOI 10.3390/jcm10061330
3. Clinical pearls and promising therapies in myositis.
   Connolly CM, Paik JJ. · · 2023 · cited 8× · PMID 37158055 · DOI 10.1080/1744666x.2023.2212162
4. A glance into the future of myositis therapy.
   Chiapparoli I, Galluzzo C, Salvarani C, Pipitone N. · · 2022 · cited 4× · PMID 35634354 · DOI 10.1177/1759720x221100299
5. A new era in the treatment of progressive fibrosing interstitial lung diseases.
   Denis A, Tsiri P, Guiot J, Tzouvelekis A. · · 2025 · cited 1× · PMID 40529319 · DOI 10.1183/20734735.0259-2024
6. Pathophysiological Insights and Clinical Management Strategies for Interstitial Lung Diseases.
   Tian L, Wang Y, Qi W, Wang B, et al · · 2025 · PMID 40803754 · DOI 10.4062/biomolther.2025.003