Last updated: March 5, 2024
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Completed
Phase
2/3
Condition
Dermatomyositis (Connective Tissue Disease)
Chest Pain
Treatment
Placebo
ANAKINRA 100 mg/daily subcutaneously
Clinical Study ID
NCT03018834
P150921
2016-003433-20
Ages 18-64 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients hospitalized for Acute myocarditis defined as:
- Chest Pain (or modification of the ECG) AND Troponin Rise (*1.5 Normal range) ANDMyocarditis proven by MRI in the first 72h after admission
- Age > 18 and <65 years old
- Accepting effective contraception during treatment duration (men and womenchildbearing potential)
- Signed informed consent Normal Coronary angiography or coronary CT Scan (made duringthe previous year is acceptable) (normal is defined as stenosis < 50%) (In the case ofpatients under 40 with typical MRI of myocarditis, coronary angiography is notmandatory and left to the doctor's discretion)
Exclusion
Exclusion Criteria:
- Active coronary disease
- Clinical Suspicion or proven underlying disease: systemic lupus, antiphospholipidantibodies, Lyme disease, trypanosomiase disease, myositis, signs of sarcoidosis,giant cell myocarditis, treated chronic inflammatory disease, tuberculosis, HIV,hepatitis B virus (HBV) or hepatitis C virus (HCV), Hepatitis B virus (HBV) infection,
- Latex allergy
- Pregnancy, breastfeeding
- Contra-indication to ANAKINRA (known hypersensitivity to the active substance or toany of the excipients, neutropenia < 1,5.10^9/L)
- Renal failure, Creatine Clearance (CrCl) < 30 ml/min (MDRD)
- Malignancy or any comorbidity limiting survival or conditions predicting inability tocomplete the study
- History of malignancy
- Non Steroidian Anti Inflammatory drug within the past 14 days
- Anti Tumor Necrosis Factor (TNF) within the past 14 days
- No affiliation to the French Health Care System "sécurité sociale"
- Hepatic impairment = Child-Pugh Class C
- Mechanical ventilation
- Circulatory assistance
Study Design
Total Participants: 120
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2/3
Study Start date:
May 30, 2017
Estimated Completion Date:
May 30, 2022
Study Description
Connect with a study center
ACTION Study Group - Department of Cardiology - Pitié Salpétrière Hospital, 47 Bd de l'Hopital
Paris, 75013
FranceSite Not Available
Department of internal medicine - Pitié Salpétrière Hospital, 47 Bd de l'Hopital
Paris, 75013
FranceSite Not Available
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