A Study to Evaluate the Safety of Rituximab Retreatment in Subjects With Systemic Lupus Erythematosus
NCT ID: NCT00137969
Last Updated: 2019-08-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
262 participants
INTERVENTIONAL
2005-05-10
2008-08-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Rituximab 1000 mg + prednisone
Participants will receive rituximab 1000 mg intravenously on Days 1, 15, 168, and 182. Participants will also receive an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants will also receive acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
Rituximab
Rituximab will be supplied as a sterile liquid for IV administration.
Prednisone
Acetaminophen
Diphenhydramine
Placebo + prednisone
Participants will receive placebo intravenously on Days 1, 15, 168, and 182. Participants will also receive an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants will also receive acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
Placebo
Placebo will be supplied as a sterile liquid for IV administration.
Prednisone
Acetaminophen
Diphenhydramine
Interventions
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Rituximab
Rituximab will be supplied as a sterile liquid for IV administration.
Placebo
Placebo will be supplied as a sterile liquid for IV administration.
Prednisone
Acetaminophen
Diphenhydramine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Active disease at screening.
* Stable use of one immunosuppressive drug.
* Use of an antimalarial drug.
* For subjects of reproductive potential (males and females), use of a reliable means of contraception throughout their study participation.
Exclusion Criteria
* Active moderate to severe glomerulonephritis.
* Retinitis, poorly controlled seizure disorder, acute confusional state, myelitis, stroke or stroke syndrome, cerebellar ataxia, or dementia that is currently active and resulting from SLE.
* Lack of peripheral venous access.
* Pregnant women or nursing (breast feeding) mothers.
* History of severe, allergic, or anaphylactic reactions to humanized or murine monoclonal antibodies.
* Significant, uncontrolled medical disease in any organ system not related to SLE that in the investigator's opinion would preclude subject participation.
* Concomitant conditions that require oral or systemic corticosteroid use.
* Known human immunodeficiency virus (HIV) infection.
* Known active infection of any kind (excluding fungal infection of nail beds) or any major episode of infection requiring hospitalization or treatment with intravenous (IV) antibiotics.
* History of deep space infection.
* History of serious recurrent or chronic infection.
* History of cancer, including solid tumors, hematological malignancies, and carcinoma in situ.
* Active alcohol or drug abuse, or history of alcohol or drug abuse.
* Major surgery.
* Previous treatment with CAMPATH-1H antibody.
* Previous treatment with any B cell-targeted therapy.
* Treatment with any investigational agent within 28 days of screening (Day -7) or 5 half-lives of the investigational drug (whichever is longer).
* Receipt of a live vaccine within 28 days prior to screening.
* Intolerance or contraindication to oral or IV corticosteroids.
* Use of a new immunosuppressive drug prior to screening or change in dose of ongoing immunosuppressive drug prior to screening.
* Prednisone dose of ≥ 1 mg/kg/day prior to screening.
* Treatment with cyclophosphamide or a calcineurin inhibitor.
* Treatment with a second immunosuppressive or immunomodulatory drug.
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2.5 x the upper limit of normal.
16 Years
75 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Paul Brunetta, M.D.
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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Univ of Alabama School of Med; Clinical Immun Rheumatology
Birmingham, Alabama, United States
Rheumatology Assoc of North AL
Huntsville, Alabama, United States
Arizona Arthritis & Rheumatology Research, Pllc
Paradise Valley, Arizona, United States
Univ of California, San Diego
La Jolla, California, United States
Univ of Calif., Los Angeles; Rheumatology
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Stanford University Med Ctr;Div of Immunology/Rheumatology
Palo Alto, California, United States
Univ of Calif, San Francisco; Rheumatology
San Francisco, California, United States
Eden Medical Center San Leandro Hospital
San Leandro, California, United States
University of Colorado Denver
Aurora, Colorado, United States
Arthritis & Rheumatism; Disease Specialities
Aventura, Florida, United States
Family Arthritis Center
Jupiter, Florida, United States
Emory Uni ; Division of Rheumatology
Atlanta, Georgia, United States
Intermountain Research Center
Boise, Idaho, United States
Coeur D'Alene Arthritis Clinic
Coeur d'Alene, Idaho, United States
Northwestern University
Chicago, Illinois, United States
Rheumatology Associates
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Tri-State Arth & Rheum Center
Evansville, Indiana, United States
Univ of Kansas Medical Center; Allergy/Clin Imm/Rheum
Kansas City, Kansas, United States
Kentuckiana Cancer Institute
Louisville, Kentucky, United States
LA State Univ; Medicine
Shreveport, Louisiana, United States
Johns Hopkins Uni
Baltimore, Maryland, United States
Center For Rheumatology & Bone Research
Wheaton, Maryland, United States
Tufts - New England Medical Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute; Rheumatology
Boston, Massachusetts, United States
University Of Michigan
Ann Arbor, Michigan, United States
Michigan Arthritis Rsrch Ctr
Brighton, Michigan, United States
Washington University; Rheumatology Division
St Louis, Missouri, United States
Center for Rheumatology, State Uni. of New York
Albany, New York, United States
SUNY Downstate Medical Center.
Brooklyn, New York, United States
NS-LIJ Health Systems; Rheum-Allergy Clin Immu
Lake Success, New York, United States
Feinstein Institute for Medical Research
Manhasset, New York, United States
NYU-Hosp for Joint Diseases; Rheum and Med
New York, New York, United States
Hospital for Special Surgery
New York, New York, United States
Buffalo Rheumatology Associates
Orchard Park, New York, United States
Long Island Osteo/Arth Center
Plainview, New York, United States
University of Rochester - Strong Memorial Hospital
Rochester, New York, United States
University of North Carolina Hospitals Department of Pharmacy; Investigational Drug Services
Chapel Hill, North Carolina, United States
Duke Medical Center
Durham, North Carolina, United States
Physicians East Pa
Greenville, North Carolina, United States
Ohio State University; Division of Nephrology
Columbus, Ohio, United States
Bone and Joint Hospital at St. Anthony Research Department
Oklahoma City, Oklahoma, United States
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States
Oklahoma Center For Arthritis Therapy & Research
Tulsa, Oklahoma, United States
Portland Medical Associates
Portland, Oregon, United States
East Penn Rheumatology Associates, Pc
Bethlehem, Pennsylvania, United States
Altoona Arthritis & Osteo Center
Duncansville, Pennsylvania, United States
Uni of Pennslyvania Medical Center
Philadelphia, Pennsylvania, United States
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Medical Univ of South Carolina
Charleston, South Carolina, United States
Arthritis Associates PLLC
Chattanooga, Tennessee, United States
Metroplex Clinical Research
Dallas, Texas, United States
Arthritis Centers of Texas
Dallas, Texas, United States
Houston Inst. For Clinical Research
Houston, Texas, United States
Arthritis & Osteoporosis Associates, LLP
Lubbock, Texas, United States
Texas Research Center
Sugar Land, Texas, United States
University of Virginia Med Ctr; Div of Ped Respiratory Med
Charlottesville, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Seattle Rheumatology Assoc; Swedish Rheumatology Research
Seattle, Washington, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
Arthritis Northwest, Spokane
Spokane, Washington, United States
Univ of Manitoba, Health Scien; Arthritis Centre
Winnipeg, Manitoba, Canada
St. Joseph'S Health Care Centre
London, Ontario, Canada
Countries
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References
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Merrill JT, Neuwelt CM, Wallace DJ, Shanahan JC, Latinis KM, Oates JC, Utset TO, Gordon C, Isenberg DA, Hsieh HJ, Zhang D, Brunetta PG. Efficacy and safety of rituximab in moderately-to-severely active systemic lupus erythematosus: the randomized, double-blind, phase II/III systemic lupus erythematosus evaluation of rituximab trial. Arthritis Rheum. 2010 Jan;62(1):222-33. doi: 10.1002/art.27233.
Other Identifiers
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U2971g
Identifier Type: -
Identifier Source: org_study_id
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