Hit hard and early. The effect of high dose methylprednisolon on nailfold capillary changes and biomarkers in early SSc: a 12-week randomized double-blind placebo-controlled trial. - Hit hard and early

Radboudumc0 个研究点目标入组 30 人开始时间: 2016年4月13日最近更新: 2024年8月12日

适应症

试验速览

暂无简介。

•- Age = 18 years
•- Fulfilling VEDOSS criteria:
•Raynauds’ Phenomenon and
•Positive for disease specific auto antibodies (anti-centromere or anti-topoisomerase antibodies) and
•Systemic sclerosis specific nail fold capillaroscopic findings
•- Puffy fingers < 3 years duration
•- modified Rodnan Skin Score =0
•- Written informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•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) no
•F.1.3.1 Number of subjects for this age range 0

•- Presence of acrosclerosis, acrosteolysis and digital ulcers
•- Presence of anti-RNA polymerase III auto antibodies
•- Previous systemic treatment for SSc, namely methotrexate, prednisone (> 14 days in previous 6 months), mofetyl mycophenolate and cyclophosphamide.
•- Clinically significant internal organ involvement: DLCO< 80% predicted, VC < 70% predicted, renal dysfunction with GFR < 60 ml/min, diastolic dysfunction > grade 1 on echocardiography, pulmonary hypertension, weight loss >10% in the last 6 months with unknown cause.
•- Contra-indications for methylprednisolone, such as pregnancy, lactation, psychotic or depressive disorder, ulcus duodeni or ventriculi, untreated hypertension (> 160-90 mmHg) or acute infections.

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