This is a 12 week double-blind randomized placebo controlled trial in which 30 patients with very early SSc, fulfilling the Very Early Diagnosis Of Systemic Sclerosis (VEDOSS) criteria (9) will be randomized in a 2:1 fashion to receive intravenous methylprednisolone or placebo. Three-day treatment courses are given at week 0, week 4 and week 8. The final assessment is at week 12, and patients will be followed up to one year after baseline
Systemic sclerosis is a disease with a high burden caused by morbidity and increased mortality. To date a cure for SSc is not available. In this trial, patients are treated very early in the disease which could change the long term outcome of SSc in these patients. In daily practice, patients so early in the disease course are not treated although they might be at risk for early escalation and internal organ involvement, reducing their prognosis. A trial to investigate the efficacy of a relative save, inexpensive and easy accessible treatment will provide us with the opportunity to change the disease course and reducing the disease burden of a portion of the SSc patients
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
30
methylprednisolone 1000 mg dissolved in 100 cc of NaCl 0.9%, by intravenous infusion in 30 minutes on three consecutive days Three-day treatment courses are given at week 0, week 4 and week 8.
100 cc of NaCl 0,9% , administered by intravenous infusion in 30 minutes on three consecutive days Three-day treatment courses are given at week 0, week 4 and week 8.
Radboudumc, Rheumatology department
Nijmegen, Gelderland, Netherlands
RECRUITINGthe change in capillary density from baseline
presence of enlarged and giant capillaries, hemorrhages, loss of capillaries, disorganization of the micro vascular array, and capillary ramifications.
Time frame: 12 weeks
change in selected biomarkers: the interferon signature in peripheral blood from baseline
Plasma biomarkers consist soluble inflammatory mediators platelet factor 4, interleukin-1β, interleukin-6, tumor necrosis factor-α, endothelin-1, intercellular adhesion molecule-1 and vascular endothelial growth factor
Time frame: 1 year
change in nail fold capillary changes other than capillary density and giant capillaries from baseline
changes in nail fold capillary pattern (early, active, late, normal
Time frame: 1 year
change in modified Rodnan skin score (mRSS) from baseline
Time frame: 1 year
presence of puffy fingers from baseline
Time frame: 1 year
presence of synovitis from baseline
Time frame: 1 year
presence of tendon friction rubs from baseline
Time frame: 1 year
fulfilling EULAR/ACR ( American College of Rheumatology )classification from baseline criteria for SSc from baseline
Time frame: 1 year
pulmonary function tests from baseline
Time frame: 1 year
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presence of interstitial lung disease from baseline
Time frame: 1 year
suspicion of pulmonary hypertension from baseline
Time frame: 1 year
Change in physical function from baseline
Time frame: 1 year
general health score from baseline
Time frame: 1 year
Change in 36-Item Short Form Survey (SF-36) total score from baseline
Time frame: 1 year
Change in Scleroderma Health Assessment Questionnaire (SHAQ)total score from baseline
Time frame: 1 year
Change in EQ-5D is a standardised instrument for use as a measure of health outcome. (EQ5D) total score from baseline
Time frame: 1 year
Change in gastrointestinal tract ( GIT ) total score from baseline
Time frame: 1 year