EUCTR2015-004613-24-BE进行中（未招募）1 期
Hit hard and early. The effect of high dose methylprednisolon on nailfold capillary changes and biomarkers in early SSc: a 12-week randomized explorative double-blind placebo-controlled trial. - Hit hard and early
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Radboudumc
- 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 clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Age = 18 years
- •- Fulfilling VEDOSS criteria:
- •Raynauds' Phenomenon and
- •Positive for disease specific auto 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
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
- •- Usage of medication that influences CYP3A4 (eg carbamazepine / fenobarbital / fenytoïne / rifampicine/itraconazol e/ claritromycine / erytromycine / HIV – proteaseinhibitors) and hypersensitivity for methylprednisolone
- •- Contra-indications for methylprednisolone, such as pregnancy, lactation, psychotic or depressive disorder, ulcus duodeni or ventriculi, untreated hypertension (> 160-90 mmHg) or acute infections
研究者
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