Systemic sclerosis Musculoskeletal Diseases Systemic sclerosis
Conditions
Interventions
Patients will be treated with rituximab, two endovenous infusions of 1000 mg, 2 weeks apart, together with 100 mg methylprednisolone at each infusion. Clinical (skin score, disease activity and diseas
Sponsors
Catholic University of the Sacred Heart (Italy)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Systemic sclerosis patients aged 18 - 70 years , either sex 2. Diffuse cutaneous involvement 3. A worsening of skin score higher than 10% despite conventional therapies
Exclusion criteria
Exclusion criteria: Severe pulmonary and cardiac involvement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of the drug and efficacy on skin score (score that evaluates fibrosis on 17 skin areas: 0 = no skin involvement, 3 = severe thickening). All clinical evaluations will be performed every three months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Efficacy of the drug on activity and severity indices 2. Global Health Status and Health Assessment Questionnaire 3. Evaluation of interleukin-6 (IL-6) and B-cell activating factor (BAFF) blood levels 4. Evaulation of the number of CD20-positive cells either in the blood either in cell infiltrate of skin biopsies All clinical evaluations will be performed every three months. Pulmonary function tests will be performed every 6 months, while skin biopsies, echocardiography and lung HRCT every 12 months. | — |
Countries
Italy
Outcome results
None listed