The Effect of High Dose Methylprednisolone on Nailfold in Early Systemic Sclerosis ( SSc )

• Status: Unknown status
• Trial end date: 2021-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radboud University
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

• Written informed consent

• Age over 18 years

• Fulfilling VEDOSS criteria (9):

• Raynauds' Phenomenon and

• Positive for disease specific auto antibodies (anti-centromere or anti-topoisomerase antibodies) and

• typical nail fold capillaroscopic findings

• Puffy fingers < 3 years

• Modified Rodnan skin score = 0

Exclusion Criteria:

• Presence of acroosclerosis, 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),

• mofetil mycophenolate

• cyclophosphamide.

Clinically significant internal organ involvement:

• diffusion capacity of lung for carbon monoxide (DLCO) < 80% predicted,

• vital capacity (VC) < 70% predicted

• renal dysfunction with glomerular filtration rate (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)

• acute infections