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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-004955-35-IT

Enrollment

Registered

2013-05-30

Start date

2013-07-29

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SYSTEMIC SCLEROSIS MedDRA version: 16.0 Level: PT Classification code 10042953 Term: Systemic sclerosis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Trade Name: Mabthera Pharmaceutical Form: Powder for infusion Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use

Eligibility

Sex/Gender

All

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
Main Objective: Safety and tolerability of Rituximab on skin and lung fibrosis in patients with Systemic Sclerosis previously treated with intravenous pulse 6-metilprednisolone and Cyclophosphamide;Secondary Objective: NA;Primary end point(s): •Rituximab efficacy on skin involvement through Rodnan skin score. We will consider clinically relevant a decrease of skin score higher than 30% compared to initial skin score •Rituximab efficacy on lung involvement. We will consider clinically relevant an increase higher than 10% for FVC and TLC and/or higher than 15% for DLCO, and/or a decrease of extension of ground glass and honey-combing scores higher of 2 points on lung HRCT •Safety and tolerability of the drug Efficacy on arthritis manifestations evaluated with DAS (disease activity score), number of swollen and tender joints, analogic scale for pain. ;Timepoint(s) of evaluation of this end point: 3/6/12/24 MONTHS	—

Measure

Time frame

Main Objective: Safety and tolerability of Rituximab on skin and lung fibrosis in patients with Systemic Sclerosis previously treated with intravenous pulse 6-metilprednisolone and Cyclophosphamide;Secondary Objective: NA;Primary end point(s): •Rituximab efficacy on skin involvement through Rodnan skin score. We will consider clinically relevant a decrease of skin score higher than 30% compared to initial skin score •Rituximab efficacy on lung involvement. We will consider clinically relevant an increase higher than 10% for FVC and TLC and/or higher than 15% for DLCO, and/or a decrease of extension of ground glass and honey-combing scores higher of 2 points on lung HRCT •Safety and tolerability of the drug Efficacy on arthritis manifestations evaluated with DAS (disease activity score), number of swollen and tender joints, analogic scale for pain. ;Timepoint(s) of evaluation of this end point: 3/6/12/24 MONTHS

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Secondary

Measure	Time frame
Secondary end point(s): • Activity and severity index for scleroderma patients • Efficacy on patient disability through “health global assessment” and “Health Assessment Questionnarie”. • Changes of capillaroscopic CSURI score, • Fibrotic and inflammatory cytokines levels in serum and plasma only in patients that accept this optional part of the study Entity of cellular infiltrate on skin biopsies before and after therapy ( 6 and 24 month) only in patients that accept this optional part of the study ;Timepoint(s) of evaluation of this end point: 3/6/12/24 MONTHS	—

Measure

Time frame

Secondary end point(s): • Activity and severity index for scleroderma patients • Efficacy on patient disability through “health global assessment” and “Health Assessment Questionnarie”. • Changes of capillaroscopic CSURI score, • Fibrotic and inflammatory cytokines levels in serum and plasma only in patients that accept this optional part of the study Entity of cellular infiltrate on skin biopsies before and after therapy ( 6 and 24 month) only in patients that accept this optional part of the study ;Timepoint(s) of evaluation of this end point: 3/6/12/24 MONTHS

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Countries

Italy

Contacts

Public ContactDIVISIONE DI REUMATOLOGIA

POLICLINICO GEMELLI- COMPLESSO INTEGRATO COLUMBUS

reumatologia@rm.unicatt.it0039063503654

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026