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.

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. - Hit hard & Early

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46262

Enrollment

Registered

2016-04-13

Start date

2017-01-16

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

scleroderma systemic sclerosis

Interventions

Investigational product/treatment: Methylprednisolone 1000 mg is prepared and administered following guidelines, in short: the methylprednisolone is dissolved in 100 cc of NaCl 0.9% by the hospital

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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 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.

Design outcomes

Primary

Measure	Time frame
The primary endpoint will be the change in capillary density between baseline and 12 weeks.	—

Secondary

Measure	Time frame
Disease progression in SSc can clinically be evaluated by various signs and symptoms such as: the modified Rodnan skin score; presence of puffy fingers; presence of tendon friction rubs; presence of restriction on pulmonary function tests and CO diffusion capacity decline; presence of interstitial lung disease as assessed by a HRCT scan of the chest; suspicion of pulmonary arterial hypertension as assessed by echocardiography; physical function, general health and utilities. 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-1β, IL-6, TNF-a, ET-1, ICAM-1 and VEGF;	—

Measure

Time frame

Disease progression in SSc can clinically be evaluated by various signs and symptoms such as: the modified Rodnan skin score; presence of puffy fingers; presence of tendon friction rubs; presence of restriction on pulmonary function tests and CO diffusion capacity decline; presence of interstitial lung disease as assessed by a HRCT scan of the chest; suspicion of pulmonary arterial hypertension as assessed by echocardiography; physical function, general health and utilities. 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-1β, IL-6, TNF-a, ET-1, ICAM-1 and VEGF;

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)