Scleroderma
Conditions
Interventions
skin biopsy of affected and non-affected skin of SSc patients.
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Main inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: 1. Diagnosis of systemic sclerosis according to ACR/ EULAR 2013 criteria or very early diagnosis of systemic sclerosis based on presence of antinuclear antibodies, and Raynaud*s phenomenon, and additionally presence of puffy fingers OR abnormal nailfold capillaroscopy (thus not fulfilling ACR/ EULAR 2013 criteria 2. Age >= 18 years 3. Disease duration: a. equal to or less than 24 months since the first non-Raynaud symptom, OR b. signs of active vasculopathy during the past 6 months including any one of the following: 1. new, painful pitting scars, 2.new digital ulcer or peripheral necrosis, 3. Newly diagnosed pulmonary arterial hypertension, 4. newly diagnosed scleroderma renal crisis. 4. Presence of Raynaud*s phenomenon 5. Signed informed consent Additional inclusion criterium for skin biopsy: 1. Skin involvement proximal to the wrist or ankles
Exclusion criteria
Exclusion criteria: Patients who have been treated with specific B cell depleting therapies (during the past 12 months) or with autologous stem cell transplantation (ever) will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insight in clinical associations and functional roles of functional vascular autoantibodies in SSc. Identification of drugable targets that can interfere with endothelial cell damage and development of fibrosis in SSC using high-throughput in-vitro models with patient derived endothelial cells, fibroblasts and blood samples. | — |
Secondary
| Measure | Time frame |
|---|---|
| Not applicable. | — |
Countries
Netherlands
Outcome results
None listed