Sjogren's syndrome
Conditions
Interventions
Rituximab infusions (1000 mg), intravenous infusion of 100 mg of
methylprednisolone before infusion of rituximab, together with 60 mg per day of
oral prednisone on days 2, 3, 16 and 17, 30 mg per da
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Stimulated whole saliva secretion >= 0,15 ml/min * Male or female of 18 years or older * Primary SS according to the revised European - U.S. criteria(22) * Positive autoantibodies (IgM-Rf *10 and SS-A and/or SS-B) * Parotid gland biopsy (paraffin material and fresh frozen tissue) with characteristic features of SS performed at time of inclusion (no longer than 24 months ago) * Use of reliable method of contraception during the first 48 weeks of the study * Written informed consent
Exclusion criteria
Exclusion criteria: * The presence of any other connective tissue disease * Preceding treatment with anti-TNF or other monoclonal antibodies than rituximab * Use of prednisone, hydroxychloroquine less than 1 month ago * Use of MTX, cyclophosphamide, cyclosporin, azathioprine and other DMARDS less than * year ago * Serum creatine > 2.8 mg/dl (250 *mol/l) * ASAT or ALAT outside 1.5 x upper normal range of the laboratory * Hb
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| * Stimulated salivary gland function (stimulated submandibular / sublingual and parotid saliva) | — |
Secondary
| Measure | Time frame |
|---|---|
| * Functional parameters * Laboratory parameters * Subjective parameters * Histological/Molecular parameters | — |
Countries
Netherlands
Outcome results
None listed