Personalised pharmacological approach to the tapering of corticosteroid doses in systemic lupus patients treated with prednisone - DECOR

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)0 个研究点目标入组 120 人开始时间: 2017年11月3日最近更新: 2017年11月6日

适应症

试验速览

暂无简介。

•1) Patient aged >= 6 years
•2) Patient who met the American College of Rheumatology criteria (ACR) or the Systemic Lupus International Collaborating Clinics Classification (SLICC) for systemic lupus erythematosus (Addenda 3)
•3) Patient needs initiation of oral prednisone regimen at least at 0,5 mg/Kg/d in combination with mycophenolate mofetyl at usual dose (2 to 3 g/d in adults; 1200 mg/m2 in children with dose <= 2 g/d), including
•i) patient who will receive bolus of methylprednisolone within the first week of inclusion for treating the lupus flare,
•ii) patient who was previously treated by a low-dose prednisone (<= 7,5 mg/day for patient >= 60 kg and 0,1 mg/kg/day for patients < 60 kg).
•4) Patients does not receive other immunosuppressive or biological drugs at inclusion
•5) Signed Informed consent form by the patient (if aged >= 18 years), or by parents / legal guardian and patient's agreement (if aged < 18 years)
•6) Patient affiliated to the health insurance system
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 60
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 30
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•1) Patient presents contraindications to corticosteroids and/or MMF
•2) Patients cannot be treated by oral way
•3) Patient whose physician has planned to stop prednisone in less than 3 months
•4) Patient (or parents for minor) are unable to give a written informed consent for physical or psychical reasons
•5) Patient disagrees with the study

发起方