Clinical Trials Logo
  1. Home
  2. Interstitial Lung Disease
  3. NCT03770663

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

Interstitial Lung Disease Clinical Trial

Official title:
Cyclophosphamide and Azathioprine vs Tacrolimus in Antisynthetase Syndrome-related Interstitial Lung Disease : Multicentric Randomized Phase III Trial

Clinical Trial 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."

Clinical Trial Description

"During the study period, according to randomization into two groups (n=38 patients, respectively), patients will receive either: - Group 1 & 2 : 3 IV pulses of Methylprednisolone (7.5 mg/kg/day followed by tapering doses of oral Prednisone, started at 1 mg/kg/day from D4 to M12 In association with : - Group 1 : European Standard of care : 6 IV pulses of Cyclophosphamide (1000 mg) followed from M5 to M12 by oral Azathioprine (2 mg/kg/day), with a maximum of 150 mg/d) - Group 2 : American Strategy Tacrolimus is given orally from M0 to M12 (started at the initial dose of 2x2mg/d). Tacrolimus doses are regularly adapted to its serum concentration to reach 5-15 ng/ml." ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03770663
Study type Interventional
Source Assistance Publique - Hôpitaux de Paris
Contact Olivier BENVENISTE, MD
Phone +33 (0)1 42 16 10 88
Email olivier.benveniste@aphp.fr
Status Recruiting
Phase Phase 3
Start date February 5, 2021
Completion date January 2, 2024
View Details
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT04905693 - Extension Study of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis Phase 3
Recruiting NCT05631132 - May Noninvasive Mechanical Ventilation (NIV) and/or Continuous Positive Airway Pressure (CPAP) Increase the Bronchoalveolar Lavage (BAL) Salvage in Patients With Pulmonary Diseases? N/A
Recruiting NCT05417776 - Collagen-targeted PET Imaging for Early Interstitial Lung Disease Phase 2
Not yet recruiting NCT04089826 - Long Term Oxygen Therapy in Patients With Interstitial Lung Disease
Recruiting NCT03467880 - Multicenter Study of Impulse Oscillometry in Chinese N/A
Completed NCT00883129 - Comparison of Therapeutic Regimens for Scleroderma Interstitial Lung Disease (The Scleroderma Lung Study II) Phase 2
Completed NCT00362739 - Blood Collection From Individuals With Lung Disease for Genetic Studies N/A
Recruiting NCT06133998 - Effects of Incentive Spirometry With and Without Aerobic Exercises in Interstitial Lung Disease N/A
Active, not recruiting NCT03485378 - Assessment of Precision Irradiation in Early NSCLC and Interstitial Lung Disease N/A
Recruiting NCT04098094 - Outcomes of RV Dysfunction in Acute Exacerbation of Chronic Respiratory Diseases
Recruiting NCT03400839 - Best Clinical Endpoints That Likely Induce Worse Prognosis in Interstitial Lung Diseases
Terminated NCT02633293 - An Open Label Extension Study to Evaluate Inhaled Treprostinil in Adult PH With ILD Including CPFE Phase 2/Phase 3
Enrolling by invitation NCT05001009 - Goals of Care Conversations Study N/A
Active, not recruiting NCT05068869 - Digital Outpatient Services N/A
Active, not recruiting NCT03727568 - Study Comparing Two Different Methods of Cryobiopsy in the Interstitial Lung Diseases N/A
Recruiting NCT06046547 - Integrating Palliative Care Education in Pulmonary Rehabilitation N/A
Completed NCT04946708 - Virtual Exercise Program in Interstitial Lung Disease (ILD) Patients N/A
Recruiting NCT04139356 - The Effect of Spontaneous Respiration on Pulse-oximetry Measurements N/A
Recruiting NCT03726398 - CompRehensive Phenotypic Characterization of Patients With Scleroderma-Associated ILD and PH Phase 2/Phase 3
Active, not recruiting NCT03295279 - WTC Chest CT Imaging Archive