Rituximab Treatment in Sjogren's Syndrome

Inclusion Criteria: * Stimulated whole saliva secretion ≥ 0,15 ml/min * Male or female \> 18 years * 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 (paraffine material and fresh frozen tissue) with characteristic features of SS performed at time of inclusion (no longer than 12 months ago) * Use of reliable method of contraception during the study * Written informed consent Exclusion Criteria: * The presence of any other connective tissue disease * Preceding treatment with anti-TNF or other monoclonal antibodies * Use of prednisone, hydroxychloroquine less than 1 month ago * Use of MTX, cyclophosphamide, cyclosporin, azathioprine and other DMARDS less than 0,5 year ago * Serum creatine \> 2.8 mg/dl (250 micromol/l) * ASAT or ALAT outside 1.5 x upper normal range of the laboratory * Hb \< 9 g/dl (5.6 mmol/l) for males and 8.5 g/dl (5.3 mmol/l) for females * Neutrophil granulocytes less than 0.5 x 109/l * Platelet count less then 50 x 109/l * Positive pregnancy test or breast-feeding * History of alcohol or drug abuse * Serious infections * Underlying cardiac, pulmonary, metabolic, renal or gastrointestinal conditions, chronic or latent infectious diseases or immune deficiency which places the patient at an unacceptable risk for participation in the study * History of any malignancy with the exception of completely resected basal cell carcinoma of the skin