A single-center randomized double-blind placebo-controlled trial Treatment of Systemic Sclerosis with Rituximab: evaluation of the effectiveness of B-cell depletion therapy”

POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI0 个研究点开始时间: 2013年5月30日最近更新: 2015年8月17日

适应症

试验速览

暂无简介。

•1.Patients with age between 18 and 70 years;
•2.SSc diagnosis with diffuse cutaneous involvement, accordingly to ACR and Le-Roy criteria;
•3.Worsening of skin involvement, evaluated with Rodnan skin score, higher than 10% in the last 2-3 months;
•4.Capacity to sign the informed consent;
•5.Previous treatment with intravenous pulse 6-metilprednisolone and oral Cyclophosphamide (at least 6 grams);
•Enrolled patients should ensure not to intend to get pregnant during the treatment and for 6 months after the last dose of Rituximab and Cyclophoasphamide
•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 14
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 2

•1.Severe lung and heart involvement, with dyspnea and signs or symptoms of heart or lung failure (Oxigen saturation lower than 60%, FVC<50%, FE<40%, DLCO<40%)
•2.Patients with acute and chronic infections;
•3.Hystory of immunodeficiency, tubercolosis or cancer;
•4.Pregnancy and feeding;
•Moderate or severe renal failure (creatinine clearance <30 ml/min)

发起方

POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI