NL-OMON46262招募中不适用
Hit hard and early. The effect of high dose methylprednisolon on nailfold capillary changes and biomarkers in early SSc: a 12-week randomised double-blind placebo-controlled trial. - Hit hard & Early
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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
排除标准
- •- 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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