Hit hard and early. The effect of high dose methylprednisolon on nailfold capillary changes and biomarkers in early SSc: a 12-week randomized explorative double-blind placebo-controlled trial.
- Conditions
- (very early) systemic sclerosisTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2015-004613-24-BE
- Lead Sponsor
- Radboudumc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 30
- Age = 18 years
- Fulfilling VEDOSS criteria:
Raynauds' Phenomenon and
Positive for disease specific auto antibodies and
Systemic sclerosis specific nail fold capillaroscopic findings
- Puffy fingers < 3 years duration
- Modified Rodnan Skin Score = 0
- Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 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
- Usage of medication that influences CYP3A4 (eg carbamazepine / fenobarbital / fenytoïne / rifampicine/itraconazol e/ claritromycine / erytromycine / HIV – proteaseinhibitors) and hypersensitivity for methylprednisolone
- 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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method