Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
24 participants
INTERVENTIONAL
2001-01-31
2006-01-31
Brief Summary
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White blood cells in the body called B cells give off substances that are active in promoting SLE disease. Researchers have found that anti-CD20 can block production of these substances in another disease. This study explores whether anti-CD20 will also be safe in people with SLE and whether it may be effective in treating SLE.
Detailed Description
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Participants receive 4 weekly infusions of study medication. Each participant is enrolled in the study for a total of 1 year with protocol visits weekly for the first 3 months, then every other week for the next 2 months, every month for the next 4 months, and every other month for the remaining 5 months of the study (Weeks 0, 1, 2, 3, 4, 5, 6, 7, 9, 11, 13, 15, 19, 23, 27, 31, 39, 47, and 55). Responses to exogenous antigens are measured; assessments for clinical response with SLE-disease activity score (SLEDEI) and systemic lupus activity measure (SLAM) score are performed. Participants complete a health questionnaire and a health survey and laboratory parameters are evaluated.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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rituximab
375 mg/m\^2 administered intravenously
Rituximab
Subjects received four weekly infusions of rituximab at a dose of 375 mg/m\^2
Interventions
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Rituximab
Subjects received four weekly infusions of rituximab at a dose of 375 mg/m\^2
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
No
Sponsors
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Autoimmunity Centers of Excellence
OTHER
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Robert A. Eisenberg, MD
Role: STUDY_CHAIR
University of Pennsylvania
Locations
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University of Colorado
Denver, Colorado, United States
University of Rochester
Rochester, New York, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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References
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Eisenberg R. Targeting B cells in SLE: the experience with rituximab treatment (anti-CD20). Endocr Metab Immune Disord Drug Targets. 2006 Dec;6(4):345-50. doi: 10.2174/187153006779025757.
Sutter JA, Kwan-Morley J, Dunham J, Du YZ, Kamoun M, Albert D, Eisenberg RA, Luning Prak ET. A longitudinal analysis of SLE patients treated with rituximab (anti-CD20): factors associated with B lymphocyte recovery. Clin Immunol. 2008 Mar;126(3):282-90. doi: 10.1016/j.clim.2007.11.012. Epub 2008 Jan 15.
Albert D, Dunham J, Khan S, Stansberry J, Kolasinski S, Tsai D, Pullman-Mooar S, Barnack F, Striebich C, Looney RJ, Prak ET, Kimberly R, Zhang Y, Eisenberg R. Variability in the biological response to anti-CD20 B cell depletion in systemic lupus erythaematosus. Ann Rheum Dis. 2008 Dec;67(12):1724-31. doi: 10.1136/ard.2007.083162. Epub 2008 Feb 4.
Related Links
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National Institute of Allergy and Infectious Diseases (NIAID)
Other Identifiers
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SACCC #ASL02
Identifier Type: OTHER
Identifier Source: secondary_id
UPenn #U1131s
Identifier Type: OTHER
Identifier Source: secondary_id
ACE Study #AC002
Identifier Type: OTHER
Identifier Source: secondary_id
DAIT AC002
Identifier Type: -
Identifier Source: org_study_id