Systemic sclerosis (SSc) Skin and Connective Tissue Diseases Systemic sclerosis
Conditions
Interventions
The participants were randomly allocated to the following two arms (ratio 1:1):
Rituximab arm: four weekly intravenous (IV) pulses of rituximab (375 mg/m^2) x 6 (24 weeks in total) and standard treat
Sponsors
University Hospital of Patras (Greece)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Both males and females 2. Detection of anti-Scl-70 autoantibodies in their sera 3. Presence of SSc-associated interstitial lung disease (ILD) as indicated by findings in either high-resolution computed tomography (HRCT) of the chest or pulmonary function tests (PFT) or both 4. Absence of any changes in medications and/or dosage of treatment administered during the last 12 months before enrolment
Exclusion criteria
Exclusion criteria: Aged less than 18 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Changes in skin histology including collagen deposition and lymphocytic infiltration 2. Changes in pulmonary function as assessed by PFT Timepoints of assessment for primary and secondary outcomes: baseline and 24 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical assessment of skin involvement by the Modified Rodnan Skin Score (MRSS) 2. Changes in HRCT scores 3. Changes in serum levels of soluble markers 4. Changes in overall functional impairment, assessed by the Health Assessment Questionnaire (HAQ) Timepoints of assessment for primary and secondary outcomes: baseline and 24 weeks. | — |
Countries
Greece
Outcome results
None listed