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

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

Timeline

Start

2017-01

Primary completion

2021-07-01

Completion

2021-07-01

Publications

• Background Geyer M, Muller-Ladner U. The pathogenesis of systemic sclerosis revisited. Clin Rev Allergy Immunol. 2011 Apr;40(2):92-103. doi: 10.1007/s12016-009-8193-3.
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• Background Tyndall AJ, Bannert B, Vonk M, Airo P, Cozzi F, Carreira PE, Bancel DF, Allanore Y, Muller-Ladner U, Distler O, Iannone F, Pellerito R, Pileckyte M, Miniati I, Ananieva L, Gurman AB, Damjanov N, Mueller A, Valentini G, Riemekasten G, Tikly M, Hummers L, Henriques MJ, Caramaschi P, Scheja A, Rozman B, Ton E, Kumanovics G, Coleiro B, Feierl E, Szucs G, Von Muhlen CA, Riccieri V, Novak S, Chizzolini C, Kotulska A, Denton C, Coelho PC, Kotter I, Simsek I, de la Pena Lefebvre PG, Hachulla E, Seibold JR, Rednic S, Stork J, Morovic-Vergles J, Walker UA. Causes and risk factors for death in systemic sclerosis: a study from the EULAR Scleroderma Trials and Research (EUSTAR) database. Ann Rheum Dis. 2010 Oct;69(10):1809-15. doi: 10.1136/ard.2009.114264. Epub 2010 Jun 15.
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• Background Czirjak L, Matucci-Cerinic M. Beyond Raynaud's phenomenon hides very early systemic sclerosis: the assessment of organ involvement is always mandatory. Rheumatology (Oxford). 2011 Feb;50(2):250-1. doi: 10.1093/rheumatology/keq374. Epub 2010 Nov 28. No abstract available.
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• Background Iudici M, van der Goes MC, Valentini G, Bijlsma JW. Glucocorticoids in systemic sclerosis: weighing the benefits and risks - a systematic review. Clin Exp Rheumatol. 2013 Mar-Apr;31(2 Suppl 76):157-65. Epub 2013 Jul 23.
• Background Matucci-Cerinic M, Bellando-Randone S, Lepri G, Bruni C, Guiducci S. Very early versus early disease: the evolving definition of the 'many faces' of systemic sclerosis. Ann Rheum Dis. 2013 Mar;72(3):319-21. doi: 10.1136/annrheumdis-2012-202295. Epub 2012 Nov 23. No abstract available.
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• Background Davies CA, Jeziorska M, Freemont AJ, Herrick AL. The differential expression of VEGF, VEGFR-2, and GLUT-1 proteins in disease subtypes of systemic sclerosis. Hum Pathol. 2006 Feb;37(2):190-7. doi: 10.1016/j.humpath.2005.10.007. Epub 2005 Dec 15.
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• Background Greenberg SA, Higgs BW, Morehouse C, Walsh RJ, Kong SW, Brohawn P, Zhu W, Amato A, Salajegheh M, White B, Kiener PA, Jallal B, Yao Y. Relationship between disease activity and type 1 interferon- and other cytokine-inducible gene expression in blood in dermatomyositis and polymyositis. Genes Immun. 2012 Apr;13(3):207-13. doi: 10.1038/gene.2011.61. Epub 2011 Sep 1.
• Background Higgs BW, Liu Z, White B, Zhu W, White WI, Morehouse C, Brohawn P, Kiener PA, Richman L, Fiorentino D, Greenberg SA, Jallal B, Yao Y. Patients with systemic lupus erythematosus, myositis, rheumatoid arthritis and scleroderma share activation of a common type I interferon pathway. Ann Rheum Dis. 2011 Nov;70(11):2029-36. doi: 10.1136/ard.2011.150326. Epub 2011 Jul 28.
• Background Miniati I, Guiducci S, Conforti ML, Rogai V, Fiori G, Cinelli M, Saccardi R, Guidi S, Bosi A, Tyndall A, Matucci-Cerinic M. Autologous stem cell transplantation improves microcirculation in systemic sclerosis. Ann Rheum Dis. 2009 Jan;68(1):94-8. doi: 10.1136/ard.2007.082495. Epub 2008 Feb 28.
• Background Hunzelmann N, Moinzadeh P, Genth E, Krieg T, Lehmacher W, Melchers I, Meurer M, Muller-Ladner U, Olski TM, Pfeiffer C, Riemekasten G, Schulze-Lohoff E, Sunderkoetter C, Weber M; German Network for Systemic Scleroderma Centers. High frequency of corticosteroid and immunosuppressive therapy in patients with systemic sclerosis despite limited evidence for efficacy. Arthritis Res Ther. 2009;11(2):R30. doi: 10.1186/ar2634. Epub 2009 Mar 4.
• Background Smith V, Decuman S, Sulli A, Bonroy C, Piettte Y, Deschepper E, de Keyser F, Cutolo M. Do worsening scleroderma capillaroscopic patterns predict future severe organ involvement? a pilot study. Ann Rheum Dis. 2012 Oct;71(10):1636-9. doi: 10.1136/annrheumdis-2011-200780. Epub 2012 Mar 8.
• Background Valentini G, Marcoccia A, Cuomo G, Vettori S, Iudici M, Bondanini F, Santoriello C, Ciani A, Cozzolino D, De Matteis GM, Cappabianca S, Vitelli F, Spano A. Early systemic sclerosis: analysis of the disease course in patients with marker autoantibody and/or capillaroscopic positivity. Arthritis Care Res (Hoboken). 2014 Oct;66(10):1520-7. doi: 10.1002/acr.22304.
• Background van den Hoogen F, Khanna D, Fransen J, Johnson SR, Baron M, Tyndall A, Matucci-Cerinic M, Naden RP, Medsger TA Jr, Carreira PE, Riemekasten G, Clements PJ, Denton CP, Distler O, Allanore Y, Furst DE, Gabrielli A, Mayes MD, van Laar JM, Seibold JR, Czirjak L, Steen VD, Inanc M, Kowal-Bielecka O, Muller-Ladner U, Valentini G, Veale DJ, Vonk MC, Walker UA, Chung L, Collier DH, Ellen Csuka M, Fessler BJ, Guiducci S, Herrick A, Hsu VM, Jimenez S, Kahaleh B, Merkel PA, Sierakowski S, Silver RM, Simms RW, Varga J, Pope JE. 2013 classification criteria for systemic sclerosis: an American college of rheumatology/European league against rheumatism collaborative initiative. Ann Rheum Dis. 2013 Nov;72(11):1747-55. doi: 10.1136/annrheumdis-2013-204424.
• Background Tan FK, Zhou X, Mayes MD, Gourh P, Guo X, Marcum C, Jin L, Arnett FC Jr. Signatures of differentially regulated interferon gene expression and vasculotrophism in the peripheral blood cells of systemic sclerosis patients. Rheumatology (Oxford). 2006 Jun;45(6):694-702. doi: 10.1093/rheumatology/kei244. Epub 2006 Jan 17.
• Background Cutolo M, Sulli A, Pizzorni C, Accardo S. Nailfold videocapillaroscopy assessment of microvascular damage in systemic sclerosis. J Rheumatol. 2000 Jan;27(1):155-60.
• Kersten BE, Lemmers JMJ, Vanhaecke A, Velauthapillai A, van den Hombergh WMT, van den Hoogen FHJ, van den Ende CHM, Smith V, Vonk MC. Efficacy of methylprednisolone in very early systemic sclerosis: results of the 'Hit Hard and Early' randomized controlled trial. Rheumatology (Oxford). 2025 Mar 1;64(3):1261-1269. doi: 10.1093/rheumatology/keae156.
• van den Hombergh WMT, Kersten BE, Knaapen-Hans HKA, Thurlings RM, van der Kraan PM, van den Hoogen FHJ, Fransen J, Vonk MC. Hit hard and early: analysing the effects of high-dose methylprednisolone on nailfold capillary changes and biomarkers in very early systemic sclerosis: study protocol for a 12-week randomised controlled trial. Trials. 2018 Aug 22;19(1):449. doi: 10.1186/s13063-018-2798-x.

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