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