Anti-CD20 Antibody Therapy for Sjogren's Syndrome

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety of the anti-CD20 antibody rituximab in treating patients with Sjogren's syndrome (SS). Rituximab is a laboratory-made antibody currently used to treat some kinds of lymphoma. Rituximab may also help people with SS, a disease of the immune system. However, the safety of rituximab in SS patients must first be established.

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

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Autoimmunity Centers of Excellence
• Treatments: Antibodies; Rituximab

Criteria

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