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Cyclophosphamide and Azathioprine vs Tacrolimus in antisynthetase syndrome-related interstitial lung disease: multicentric randomized phase III trial
EU CTIS ID: 2024-511868-83-00
What this study is testing
To compare the efficacy of Cyclophosphamide and Azathioprine vs Tacrolimus in patients with ASS related-ILD.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18
- Signed informed consent
- Affiliation to the Social security system
- Diagnosis of ASS: positive test for any of the 5 anti-tRNA synthetase antibodies routinely tested (ELISA, Luminex or Linear-dot), including anti-Jo-1, anti-PL7, anti-PL12, anti-EJ and anti-OJ, up to 3 months prior to inclusion.
- Diagnosis of ILD-related ASS: interstitial lung disease on HRCT
- Moderate to severe ILD on PFT: FVC < 80% and or cDLCO < 70%
You likely can't join if
- Pregnancy and/or breast feeding
- Positivity of auto-antibodies associated to Systemic Sclerosis (anti-Telomerase, anti-Centromères, anti-Polymerase III).
- Patients with QTc > 450 msec
- Patients with history of long QT syndrome (including familial) or ventricular arrhythmias
- Concomitant use of drugs prolonging QT / QTc (list of treatments in annex)
- Hypokalemia
See the full eligibility criteria
- Age ≥ 18
- Signed informed consent
- Affiliation to the Social security system
- Diagnosis of ASS: positive test for any of the 5 anti-tRNA synthetase antibodies routinely tested (ELISA, Luminex or Linear-dot), including anti-Jo-1, anti-PL7, anti-PL12, anti-EJ and anti-OJ, up to 3 months prior to inclusion.
- Diagnosis of ILD-related ASS: interstitial lung disease on HRCT
- Moderate to severe ILD on PFT: FVC < 80% and or cDLCO < 70%
- Beta-HCG test negative or negative uterine echography (for women of child bearing potential)
- Women of childbearing potential must have an effective contraceptive measure (hormonal, intrauterine device, intrauterine hormone-releasing system, sterilization method)) during all the duration of study treatment and 12 months after the last dose of study treatment
- Males who are sexually active with women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of study treatment and 6 months after the last dose of study treatment
- Pregnancy and/or breast feeding
- Positivity of auto-antibodies associated to Systemic Sclerosis (anti-Telomerase, anti-Centromères, anti-Polymerase III).
- Patients with QTc > 450 msec
- Patients with history of long QT syndrome (including familial) or ventricular arrhythmias
- Concomitant use of drugs prolonging QT / QTc (list of treatments in annex)
- Hypokalemia
- Patients with pulmonary hypertension detected on echocardiography during the screening/selection visit (systolic pulmonary artery pressure (PAP) was 37–50 mmHg, and/or tricuspid regurgitation velocity 2.8–3.4 ms-1) are excluded.
- Others contraindications to the treatments, including hypersensitivity to the drug (including excipient and active compounds), medical contraception contraindications, severe renal failure, severe hepatic insufficiency and severe psychiatric disorders. Specific contraindications are listed for each experimental medication in Table 6 (according to updated Summary of product characteristics, see Appendix 7)
- Fever or active bacterial infection (ie. septicemia, pneumopathy, pyelonephritis, acute prostatitis …), or parasitic infection (ie. Anguillulosis …), or fungal infection (ie. Invasive pulmonary aspergillosis …), or viral infection (HIV seropositivity, Active Tuberculosis, active B/C viral hepatitis, CMV, active EBV…)
- Active neoplasm
- Previous inefficacy of Cyclophosphamide, Azathioprine or Tacrolimus, not related to adhesion problems.
- Previous use of 3 daily IV steroids < 3 months, and > 10 days before patient's morphological and functional examination for enrollment (CT-scan and PFT).
- ASS-related ILD worsening or relapse while considering inclusion under Prednisone > 0.5 mg/kg/day, > 30 days prior to inclusion.
- Previous use of Cyclophosphamide, Azathioprine or Tacrolimus in the last 6 months.
- Severe ASS requiring ICU at the time of inclusion (respiratory disease, myocarditis), plasma exchange or IV-Ig.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.