Determining the Responses and Impact of Rituximab-instigated Cell Depletion on T Cells in People With SLE

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine how B cell subsets and autoantibodies are related to disease remission after rituximab treatment in subjects with Systemic Lupus Erythematosus (SLE).

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

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Rituximab

Criteria

Inclusion Criteria:

• Diagnosis of SLE

• Positive ANA with a titer of at least 1:160

• Active disease (one or more modified BILAG A or B) or inability to lower steroids to leass than 20 mg/day. More information about this criterion can be found in the protocol.

• For females, must agree to use effective birth control methods for the duration of the study

Exclusion Criteria:

• Severe thrombocytopenia

• Active, moderate, or severe proliferative glomerulonephritis

• Active CNS manifestations due to lupus other than migraines, mild cognitive dysfunction, or mood disorders. More information about this criterion can be found in the protocol.

• Poorly controlled anti-phospholipid syndrom

• Significant organ dysfunction

• Conditions, other than SLE, that are likely to require prolonged systemic steroids

• Chronic infections. More information about this criterion can be found in the protocol.

• Hepatitis B infection

• Hepatitis C infection

• Deep space infection within two years of study entry

• Severe bacterial infection within three months of study entry

• More than one severe bacterial infection within two years of study entry

• Positive purified protein derivative tuberculin skin test

• History of cancer, not including basal cell carcinomas and carcinoma in situ of the cervix with documentation of successful treatment

• Alcohol or drug abuse

• Surgery within three months of study entry

• Immunization with a live vaccine within two months of study entry

• Any immunization within one month of study entry

• Received cyclophosphamide or calcineurin inhibitors within six months of study entry

• Received anti-TNF alpha antibody within 3 months of study entry

• Received etanercept within one month of study entry

• Received anti-CD20 antibodies or other lymphocyte depleting antibodies

• Received Immunoglobin G infusion protein or monoclonal antibody

• Treatment with FDA non-approved agents within six months of study entry

• Transaminases greater than two times the upper limit of normal

• Pregnant or breastfeeding