Anti-CD20 Antibody Therapy for Sjogren's Syndrome

Inclusion Criteria:

• Weighs at least 40 kg (88.2 lbs)
• Meets European criteria proposed by the American-European Consensus Group for primary Sjogren's syndrome
• Has 1 or more of the following symptoms of Sjogren's syndrome: fatigue; joint pain; peripheral neuropathy; interstitial lung disease; leukocytoclastic vasculitis; renal tubular acidosis; interstitial nephritis; severe parotid swelling; or other extraglandular manifestations causing organ system dysfunction
• Agrees to use acceptable methods of contraception during the study and for 12 months after the end of treatment

Exclusion Criteria:

• Active infection
• Chronic or persistent infection which might be worsened by immunosuppressive treatment (e.g., HIV, hepatitis B or C, tuberculosis [TB])
• Known coronary artery disease, significant cardiac arrhythmias, or severe congestive heart failure (New York Heart Association class III or IV)
• Current use of anticoagulants
• Prior use of rituximab
• Cyclophosphamide treatment within 24 weeks prior to screening
• Certain medications that may cause dry mouth
• Cytotoxic therapy with azathioprine, cyclosporine, methotrexate, or mycophenolate mofetil within 4 weeks prior to screening
• Etanercept within 4 weeks prior to screening
• Adalumimab within 8 weeks prior to screening
• Infliximab within 12 weeks prior to screening
• Prednisone at greater than 10 mg/day within 2 weeks prior to screening. Patients who have their steroid doses tapered to 10 mg/day or less within 2 weeks of screening are not excluded.
• Definitive diagnosis of another autoimmune rheumatologic disease (e.g., systemic lupus erythematosus, scleroderma, rheumatoid arthritis)
• History of alcohol or substance abuse
• History of immunoglobulin E (IgE)-mediated or non-IgE-mediated hypersensitivity
• Known anaphylaxis to mouse-derived proteins
• History of head and neck radiation therapy
• History of sarcoidosis (inflammation of unknown cause occurring in the lymph nodes, lungs, liver, eyes, skin, or other tissues)
• History of graft-versus-host disease
• History of cancer. Patients who have had resected basal or major squamous cell carcinoma, cervical dysplasia, or in situ cervical cancer Grade I within the last 5 years prior to study entry are not excluded.
• History of positive PPD without documentation of treatment for TB infection or chemoprophylaxis for TB exposure
• Live vaccines within the 3 months prior to study entry
• Severe pulmonary disease. Patients who do not have undue fatigue or dyspnea following ordinary physical activity are not excluded.
• Psychiatric disorder precluding informed consent
• Inability or unwillingness to follow study requirements
• Any current condition or treatment that, in the opinion of the investigator, may interfere with the study
• Pregnancy