Systemic sclerosis, Scleroderma, CREST Syndrome, SSc Scleroderma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: A: very early SSc patients, fulfilling at least one of the following three criteria: - Raynaud’s phenomenon - Puffy fingers less than 3 years - Abnormal nailfold capillaries including capillary enlargement (>= 50 um) and/ or loss (=< 7 capillaries per mm)AND - Not fulfilling the ACR/EULAR 2013 criteria (less than 9 points) OR B: established SSc, fulfilling all criteria: - Fulfilling ACR/EULAR 2013 criteria - Clinical diagnosis of SSc according to the treating physician - First SSc attributed symptom other than Raynaud’s less then 24 months before inclusion. 2. Presence of ATA+ or ACA+ antibodies 3. Age of =18 years 4. Written informed consent for this study
Exclusion criteria
Exclusion criteria: Patients with another systemic auto-immune diseasePatients who underwent an autologous stem cell transplantationPatients who received B cell depleting therapy in the past 6 months Patients who received prednisolone > 1 mg/ kg > 4 weeks in the past 6 months or >= 1000 mg methylprednisolone IV during the past month
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease progression | — |
Secondary
| Measure | Time frame |
|---|---|
| Health related quality of life and brief illness perception questionnaires in patients with very early and early SSc. | — |
Countries
Netherlands
Contacts
Leids Universitair Medisch Centrum