Hit hard and early. The effect of high dose methylprednisolon on nailfold capillary changes and biomarkers in early SSc: a 12-week randomised double-blind placebo-controlled trial.
- Conditions
- sclerodermasystemic sclerosis100038161001076110014982
- Registration Number
- NL-OMON46262
- Lead Sponsor
- Radboud Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
Age >= 18 years
- Fulfilling VEDOSS criteria:
• Raynauds* Phenomenon AND
• Positive for disease specific auto antibodies (anti-centromere or anti-topoisomerase antibodies) AND
• Systemic- sclerosis specific nail fold capillaroscopic findings
- Puffy fingers < 3 years duration
- modified Rodnan Skin Score =0
- Presence of acrosclerosis, acrosteolysis and digital ulcers
- Presence of anti-RNA polymerase III auto antibodies
- Previous systemic treatment for SSc, namely methotrexate, prednisone (> 14 days in previous 6 months), mofetyl mycophenolate and cyclophosphamide.
- Clinically significant internal organ involvement: DLCO< 80% predicted, VC < 70% predicted, renal dysfunction with GFR < 60 ml/min, diastolic dysfunction > grade 1 on echocardiography, pulmonary hypertension, weight loss >10% in the last 6 months with unknown cause.
- Contra-indications for methylprednisolone, such as pregnancy, lactation, psychotic or depressive disorder, ulcus duodeni or ventriculi, untreated hypertension (> 160/90 mmHg) or acute infections.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint will be the change in capillary density between baseline<br /><br>and 12 weeks.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Disease progression in SSc can clinically be evaluated by various signs and<br /><br>symptoms such as:<br /><br>the modified Rodnan skin score;<br /><br>presence of puffy fingers; presence of tendon friction rubs;<br /><br>presence of restriction on pulmonary function tests and CO diffusion capacity<br /><br>decline;<br /><br>presence of interstitial lung disease as assessed by a HRCT scan of the chest;<br /><br>suspicion of pulmonary arterial hypertension as assessed by echocardiography;<br /><br>physical function, general health and utilities.<br /><br><br /><br>The secondary outcomes of this study are: (all compared between baseline and<br /><br>week 12 and between baseline and 1 year) change in selected biomarkers: the<br /><br>interferon signature in peripheral blood cells CXCL4, IL-1β, IL-6, TNF-a, ET-1,<br /><br>ICAM-1 and VEGF; </p><br>