About this trial
Safety, tolerability and efficacy of Descarte-08 in children, adolescents and young adults with childhood-onset systemic lupus erythematosus, ANCA-associated vasculitis, juvenile myasthenia gravis, and juvenile dermatomyositis
Eligibility criteria
Qualifiers
At least age 12
definitive diagnosis of childhood-onset systemic lupus erythematous, juvenile Myasthenie gravis, juvenile dermatomyositis and AAV
Signs and symptoms of moderate disease
History of systemic treatment
Disqualifiers
Major chronic illness that is not well managed at the time of study entry and in the opinion of the investigator may increase the risk to the patient;
Abnormal PT/INR or PTT increased > 1.5-fold or patient is on anticoagulation therapy (except in cases of elevated PTT with documented lupus anticoagulant; or in patients who have been on stable doses of anticoagulation therapy for more than 6 months of VTE diagnosis; or in patients on stable doses of anticoagulation therapy for at least 8 weeks of atrial fibrillation diagnosis; these conditions will not be exclusionary unless, in the investigator's opinion, they make participation in the study unsafe);
ANC < 1000 cells/microliter ;
Hemoglobin < 8.0 g/dL ;
Trial design
Treatments tested in this trial
- Descartes-08