Hit hard and early

Phase 1

Conditions: (very early) systemic sclerosis
Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Registration Number: EUCTR2015-004613-24-NL

Lead Sponsor: Radboudumc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

- 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
- 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

Exclusion Criteria

- 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 clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the changes of high dose intravenous methylprednisolone on nail fold capillaries as measured by nail fold capillary microscopy (NCM) at week 12;Secondary Objective: To investigate the effects of glucocorticoids on signs and symptoms of disease progression.<br><br>To analyze the effect of glucocorticoids on inflammatory biomarkers that have been implicated in SSc pathogenesis;Primary end point(s): In this study, the primary endpoint will be the change in capillary density between baseline and 12 weeks.;Timepoint(s) of evaluation of this end point: 12 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary outcomes of this study are: (all compared between baseline and week 12 and between baseline and 1 year) change in selected biomarkers: the interferon signature in peripheral blood cells CXCL4, IL-1ß, IL-6, TNF-a, ET-1, ICAM-1 and VEGF; change in nail fold capillary changes other than capillary density and giant capillaries; changes in nail fold capillary pattern (early, active, late, normal); change in modified Rodnan skin score; presence of puffy fingers; presence of synovitis, presence of tendon friction rubs; fulfilling EULAR/ACR classification criteria for SSc (24), pulmonary function tests; presence of interstitial lung disease; suspicion of PH; and physical function, general health and utilities as measured by the SHAQ, SF-36, EQ5D and GIT.;Timepoint(s) of evaluation of this end point: 12 months

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