Rituximab Treatment in Sjogren's Syndrome

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is an evaluation of the effect of rituximab compared to placebo in combination with steroids on salivary flow and serological and clinical parameters in patients with primary SS.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Medical Center Groningen
• Collaborator: Hoffmann-La Roche
• Treatments: Rituximab

Criteria

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