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 characteristicfeatures 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 0,5year 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 atan unacceptable risk for participation in the study

• History of any malignancy with the exception of completely resected basal cellcarcinoma of the skin