Safety and Tolerability of MEDI-545 in Patients Who Have Systemic Lupus Erythematosus (SLE)
NCT ID: NCT00299819
Last Updated: 2007-12-18
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
45 participants
INTERVENTIONAL
2006-03-31
2007-10-31
Brief Summary
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Detailed Description
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The secondary objective of this study is to describe the pharmacokinetics and potential immunogenicity of MEDI-545.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Study Groups
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1
MEDI-545
MEDI 545
0.3 mg/kg IV (n=6) at Study Day 0
2
MEDI-545
MEDI-545
0.3 mg/kg IV (n=6) at Study Day 0
3
MEDI-545
MEDI-545
0.3 mg/kg IV (n=6) at Study Day 0
4
MEDI-545
MEDI-545
0.3 mg/kg IV (n=6) at Study Day 0
5
MEDI-545
MEDI-545
0.3 mg/kg IV (n=6) at Study Day 0
Interventions
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MEDI-545
0.3 mg/kg IV (n=6) at Study Day 0
MEDI 545
0.3 mg/kg IV (n=6) at Study Day 0
MEDI-545
0.3 mg/kg IV (n=6) at Study Day 0
MEDI-545
0.3 mg/kg IV (n=6) at Study Day 0
MEDI-545
0.3 mg/kg IV (n=6) at Study Day 0
Eligibility Criteria
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Inclusion Criteria
* Adult males and females ≥ 18 years at the time of the first dose of study drug.
* Written informed consent obtained from the patient/patient's legal guardian
* Diagnosis of SLE: Patients must have previously met ≥ 4 of the 11 revised ACR criteria
* Current background treatments may include the following medications prior to randomization: acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs), and antimalarials, such as hydroxychloroquine ≤ 600 mg/day, and prednisone ≤ 20 mg daily (or an equivalent dose of another oral corticosteroid) for at least 28 days
* Sexually active females, unless surgically sterile or at least two years post-menopausal, must use an effective method of avoiding pregnancy (including oral, injectable, transdermal, or implanted contraceptives, IUD, female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner) for 28 days before the first dose of study drug, and must agree to continue using such precautions through the study period of 84 days. Cessation of birth control after this point should be discussed with a responsible physician. Sexually active males, unless surgically sterile, must likewise use an effective method of birth control (condom or abstinence) and must agree to continue using such precautions through Study Day 84.
* Ability to complete follow-up period of 84 days as required by the protocol.
Exclusion Criteria
* Use of cyclophosphamide, azathioprine, methotrexate, mycophenolate mofetil or cyclosporine within 28 days before study entry
* Use of doses of corticosteroids higher than the equivalent of prednisone 20 mg/day (or an equivalent dose of another corticosteroid) within 28 days before study entry
* In the opinion of the investigator, a likelihood of requiring initiation of immunosuppressant therapy (e.g., prednisone \>20 mg daily (or an equivalent dose of another oral corticosteroid), azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, or dapsone) within the 28 days after study entry. Antimalarial dosing must be held constant during the study, but analgesics and NSAIDs may be varied.
* Current treatment with coumadin
* Treatment with immunoglobulin or blood products within 28 days before entry into the study
* Treatment with any investigational drug therapy within 28 days before entry into the study; in the case of cell-depleting therapies, such as B or T cell depletion, cell counts that remain below acceptable or baseline levels (use of licensed agents for indications not listed in the package insert is permitted)
* History of primary immunodeficiency
* History of allergic reactions likely to be exacerbated by any component of the study drug
* Previous medical history, or evidence, of an intercurrent illness, other than SLE, that may compromise the safety of the patient in the study
* Clinically significant cardiac disease, including: unstable angina; myocardial infarction within 6 months; congestive heart failure; arrhythmia requiring active therapy, with the exception of clinically insignificant extra systoles, or minor conduction abnormalities; and history of clinically significant abnormality on electrocardiogram
* Evidence of significant active infection, or vaccination with live attenuated viruses, currently or in the 2 weeks before randomization
* Evidence of infection with hepatitis B or C virus, or HIV-1 or HIV-2, or active infection with hepatitis A, as determined by results of testing at screening
* A history of severe infection with viruses of the herpes family including Epstein-Barr virus requiring hospitalization, disseminated herpes, herpes encephalitis, ophthalmic herpes, or cytomegalovirus
* Herpes zoster ≤ 3 months prior to screening
* Current suppressive antiviral therapy for herpes or other viral infections
* Ongoing, chronic infectious disease such as chronic renal infection or chronic chest infection with bronchiectasis or sinusitis
* Pregnancy (females, unless surgically sterile or at least two years post-menopausal must have a negative serum pregnancy test within 14 days before receiving the study drug and a negative urine pregnancy test on Study Day 0 before receiving the study drug)
* Nursing mother
* History of alcohol or drug abuse within the past 2 years
* Presence of end-stage renal disease, or rapidly progressive glomerulonephritis
* Active central nervous system lupus
* History of stroke, or any cerebrovascular disease requiring medication/treatment.
* History of cancer, apart from basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy \>1 year prior to enrollment
* At screening (must be within14 days before entry into the study) any of the following:
* AST \> 1.5x upper limit of normal range (ULN)
* ALT \> 1.5x ULN
* creatinine \> 1.5x ULN for patient's age, sex and weight
* serum K above or below the normal range
* hemoglobin \< 8 g/dL
* white blood cell count \< 1,800/mm3 (Superscript)
* neutrophils \< 1,500/mm3 (Superscript)
* platelet count \< 50,000/mm3 (Superscript)
* other abnormal laboratory values in the screening panel that in the opinion of the principal investigator are judged to potentially confound analysis of study results
18 Years
80 Years
ALL
No
Sponsors
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MedImmune LLC
INDUSTRY
Responsible Party
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MedImmune Inc.
Principal Investigators
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Barbara White, M.D.
Role: STUDY_DIRECTOR
MedImmune LLC
Locations
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Pinnacle Research Group
Anniston, Alabama, United States
Wallace Rheumatic Study Center
Los Angeles, California, United States
Clinical Research of West Florida
Clearwater, Florida, United States
Center for Rhematology, Immunology, and Arthritis
Fort Lauderdale, Florida, United States
Ocala Rheumatology Research Center
Ocala, Florida, United States
Tampa Florida Medical Research Group
Tampa, Florida, United States
Florida Medical Clinic, Clinical Research Division
Zephyrhills, Florida, United States
Louisiana State University Health Sciences Center-Shreveport
Shreveport, Louisiana, United States
Johns Hopkins University, School of Medicine
Baltimore, Maryland, United States
St. Mary's Duluth Clinic
Duluth, Minnesota, United States
Hospital for Special Surgery
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States
Oregon Medical Research Center
Portland, Oregon, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
University of Washington Div. of Rhematology
Seattle, Washington, United States
Center for Innovative Therapy, UCSD School of Medicine
Milwaukee, Wisconsin, United States
Froedtert Hospital, Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Toronto Western Hospital
Toronto, Ontario, Canada
Montreal General Hospital
Montreal, Quebec, Canada
Countries
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References
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Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
Merrill JT, Wallace DJ, Petri M, Kirou KA, Yao Y, White WI, Robbie G, Levin R, Berney SM, Chindalore V, Olsen N, Richman L, Le C, Jallal B, White B; Lupus Interferon Skin Activity (LISA) Study Investigators. Safety profile and clinical activity of sifalimumab, a fully human anti-interferon alpha monoclonal antibody, in systemic lupus erythematosus: a phase I, multicentre, double-blind randomised study. Ann Rheum Dis. 2011 Nov;70(11):1905-13. doi: 10.1136/ard.2010.144485. Epub 2011 Jul 27.
Yao Y, Richman L, Higgs BW, Morehouse CA, de los Reyes M, Brohawn P, Zhang J, White B, Coyle AJ, Kiener PA, Jallal B. Neutralization of interferon-alpha/beta-inducible genes and downstream effect in a phase I trial of an anti-interferon-alpha monoclonal antibody in systemic lupus erythematosus. Arthritis Rheum. 2009 Jun;60(6):1785-96. doi: 10.1002/art.24557.
Other Identifiers
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MI-CP126
Identifier Type: -
Identifier Source: org_study_id
NCT00394719
Identifier Type: -
Identifier Source: nct_alias