NCT00379431

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

Completed Phase 2 Last updated 20 December 2022

What this trial tests

Phase 2 trial testing Administration of rituximab and methylprednisolone in Early and Severe Systemic Sclerosis in 9 participants. Completed in 2 February 2009.

Timeline

27 November 2006

Primary endpoint
2 February 2009

2 February 2009

Quick facts

Lead sponsor	University Hospital, Ghent
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	9
Start date	27 November 2006
Primary completion	2 February 2009
Estimated completion	2 February 2009
Sites	4 locations across Belgium

Drugs / interventions tested

• Administration of rituximab and methylprednisolone — full drug profile →

Conditions studied

• Early and Severe Systemic Sclerosis — all drugs for Early and Severe Systemic Sclerosis →

Sponsor

University Hospital, Ghent

Who can join

18 and older, any sex, with Early and Severe Systemic Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Smith V, Piette Y, van Praet JT, Decuman S, et al · · 2013 · cited 60× · PMID 23118116 · DOI 10.3899/jrheum.120778
2. Pharmacotherapy of systemic sclerosis.
   Postlethwaite AE, Harris LJ, Raza SH, Kodura S, et al · · 2010 · cited 15× · PMID 20210685 · DOI 10.1517/14656561003592177
3. Assessment of sensitivity to change of the European Scleroderma Study Group activity index.
   Melsens K, De Keyser F, Decuman S, Brusselle G, et al · · 2016 · cited 2× · PMID 27463733
4. 11. Recent Advances in Therapy.
   · 2018 · PMID 35381991 · DOI 10.1177/2397198317753491