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

• Conditions: SYSTEMIC SCLEROSIS; MedDRA version: 16.0Level: PTClassification code 10042953Term: Systemic sclerosisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2012-004955-35-IT
• Lead Sponsor: POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-30
• Last Update Posted: 17 August 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified