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

Withdrawn before enrolling · Phase 2

Conditions studied: Lupus Erythematosus, Systemic

In brief

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).

Key facts

Study ID

NCT01702038

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

0

Starts

2009-09-01

Last updated by the study team

2012-10-08

Who can join

Age: 19 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of Rochester — Rochester, New York, United States

Full record on ClinicalTrials.gov

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