Anti-CD20 in Systemic Lupus Erythematosus
Lupus Erythematosus, Systemic
About this trial
This is an interventional treatment trial for Lupus Erythematosus, Systemic focused on measuring Systemic Lupus Erythematosus, SLE, B-Lymphocytes, anti-CD20, rituximab
Eligibility Criteria
Inclusion Criteria People may be eligible for this study if they: Are 18 to 70 years of age Agree to use a reliable method of birth control during treatment and for 6 months after treatment ends Have SLE (by the American College of Rheumatology criteria) Have had SLE for at least 6 months prior to screening Have active SLE disease at the screening visit Have organ disease (lung, stomach, intestinal, blood, kidney, and/or heart) Have failed standard therapy, including at least 1 immunosuppressive agent, or have experienced side effects from an immunosuppressive agent that required discontinuation of treatment Meet blood, liver, and kidney laboratory values set by the protocol Have not taken an immunosuppressive agent for 2 weeks prior to the first treatment Have been on a stable dose of oral corticosteroids, if taking them, for 4 weeks before the first week's visit. Oral corticosteroids may be altered as medically necessary after enrollment. Have at least 1 elevated autoantibody level at screening visit. Exclusion Criteria People will not be eligible for this study if they: Are pregnant or breast-feeding Have heart, lung, nervous system, kidney, liver, stomach, intestinal, or other diseases that may place the patient at risk if participating in the trial Have cranial neuropathy (a condition affecting the head region) Are on blood-thinning agents to prevent blood clotting Have a serious skin disease Have a certain class of heart disease Have had cancer, unless surgically cured basal cell carcinoma or cervical dysplasia Have a long term serious infectious disease such as tuberculosis or a fungal infection that is now active, or active within 2 years of the baseline visit Have had HIV infection or another immunosuppressive state (chemotherapy or radiation therapy) Have received any experimental drug within 30 days of baseline visit Have received any monoclonal antibody or similar medication within 3 months of the baseline visit Received any intravenous, joint, or muscle injection of corticosteroids within 4 weeks of the baseline visit Abuse alcohol or drugs Are unwilling or unable to follow the protocol Have poor veins for receiving injections.
Sites / Locations
- University of Colorado
- University of Rochester
- University of Pennsylvania
Arms of the Study
Arm 1
Experimental
rituximab
375 mg/m^2 administered intravenously