A Protocol Based Treatment for Early and Severe Systemic Sclerosis With (Anti-CD20), Rituximab

Summary

Rituximab 1000 mg i.v. will be given on day 1 and 15, week 26 - 28, together with a corticosteroid regimen consisting of methylprednisolone 100 mg i.v. 30 minutes prior to both infusions.

Timeline

Start

2006-11-27

Primary completion

2009-02-02

Completion

2009-02-02

Publications

• Melsens K, De Keyser F, Decuman S, Brusselle G, De Pauw M, Deschepper E, De Wilde K, Elewaut D, Piette Y, Vandecasteele E, Smith V. Assessment of sensitivity to change of the European Scleroderma Study Group activity index. Clin Exp Rheumatol. 2016 Sep-Oct;34 Suppl 100(5):148-151. Epub 2016 Jul 18.
• Smith V, Pizzorni C, Riccieri V, Decuman S, Brusselle G, DE Pauw M, Deschepper E, Piette Y, Ruaro B, Sulli A, Vandecasteele E, Melsens K, DE Keyser F, Cutolo M. Stabilization of Microcirculation in Patients with Early Systemic Sclerosis with Diffuse Skin Involvement following Rituximab Treatment: An Open-label Study. J Rheumatol. 2016 May;43(5):995-6. doi: 10.3899/jrheum.151018. No abstract available.
• Bonroy C, Smith V, Deschepper E, De Keyser F, Devreese K. Specific Antinuclear Antibody Level Changes after B Cell Depletion Therapy in Systemic Sclerosis Are Associated with Improvement of Skin Thickening. J Rheumatol. 2016 Jan;43(1):247-9. doi: 10.3899/jrheum.150105. No abstract available.
• Smith V, Piette Y, van Praet JT, Decuman S, Deschepper E, Elewaut D, De Keyser F. Two-year results of an open pilot study of a 2-treatment course with rituximab in patients with early systemic sclerosis with diffuse skin involvement. J Rheumatol. 2013 Jan;40(1):52-7. doi: 10.3899/jrheum.120778. Epub 2012 Nov 1.
• Smith V, Van Praet JT, Vandooren B, Van der Cruyssen B, Naeyaert JM, Decuman S, Elewaut D, De Keyser F. Rituximab in diffuse cutaneous systemic sclerosis: an open-label clinical and histopathological study. Ann Rheum Dis. 2010 Jan;69(1):193-7. doi: 10.1136/ard.2008.095463.

Drugs

Indications