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

National Institute of Allergy and Infectious Diseases (NIAID)

Status and phase

Withdrawn

Phase 2

Conditions

Lupus Erythematosus, Systemic

Treatments

Drug: Rituximab

Study type

Interventional

Funder types

NIH

Identifiers

NCT01702038

DAIT ALE01

Details and patient eligibility

About

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).

Full description

Immune cells are an important part of the abnormal autoimmune response in SLE. The B cell is a significant part of this autimmune response because it produces the antibodies which can react with normal tissue of the body. B cells have the ability to accumulate and promote the development of SLE. 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 SLE.

This study will last approximately two years and consist of 15 study visits. These visits will occur at screening, baseline, Days 0 and 14, and Months 1, 2, 3, 4, 6, 9, 12, 15, 18, 21, and 24. Participants will receive a single rituximab injection on Days 0 and 14. Medication history and blood tests will occur at every study visit. A physical exam, medical history, and urine tests will occur at most visits. For females, a pregnancy test will occur at selected visits.

Sex

All

Ages

19 to 65 years old

Volunteers

No Healthy Volunteers

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