Subcutaneous Treatment In Randomized Subjects To Evaluate Safety And Efficacy In Generalized Lupus Erythematosus
NCT ID: NCT01405196
Last Updated: 2017-12-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
183 participants
INTERVENTIONAL
2011-12-31
2014-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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10 mg of PF-04236921
PF-04236921
subcutaneous injection; administered at day 1, weeks 8, 16.
50 mg of PF-04236921
PF-04236921
subcutaneous injection; administered at day 1, weeks 8, 16.
200 mg of PF-04236921
PF-04236921
subcutaneous injection; administered at day 1, weeks 8, 16.
Placebo
PF-04236921
subcutaneous injection; administered at day 1, weeks 8, 16
Interventions
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PF-04236921
subcutaneous injection; administered at day 1, weeks 8, 16.
PF-04236921
subcutaneous injection; administered at day 1, weeks 8, 16.
PF-04236921
subcutaneous injection; administered at day 1, weeks 8, 16.
PF-04236921
subcutaneous injection; administered at day 1, weeks 8, 16
Eligibility Criteria
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Inclusion Criteria
* Have a clinical diagnosis of SLE according to 1997 update on the revised 1982 American College of Rheumatology (ACR) criteria.
* Have a unequivocally positive anti-nuclear antibody (ANA) test result.
* Active disease at screening defined by both: SLEDAI-2K score greater than or equal to 6 and BILAG Level A disease in more than or equal to 1 organ system (except renal or central nervous system) or BILAG B disease in more than or equal to 2 organ systems if no level A disease in present.
Exclusion Criteria
* Have received any of the following within 364 days of day 1: a biologic investigational agent other than B cell targeted therapy; required 3 or more courses of systemic corticosteroids for concomitant conditions; history of previously untreated or current evidence of active or untreated latent infection with Tuberculosis (TB), evidence of prior untreated or currently active TB by chest radiography, residing with or frequent close contact with an individual with active TB.
18 Years
75 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Anniston Medical Clinic, PC
Anniston, Alabama, United States
Pinnacle Research Group, LLC
Anniston, Alabama, United States
Achieve Clinical Research, LLC
Birmingham, Alabama, United States
Med Investigations, Inc.
Fair Oaks, California, United States
Premier Clinical Research, LLC
Lakewood, California, United States
Novo Research
Long Beach, California, United States
St Mary Medical Center
Long Beach, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Wallace Rheumatic Study Center
Los Angeles, California, United States
UCLA Division of Rheumatology
Los Angeles, California, United States
UCLA Rheumatology Clinical Research Center
Los Angeles, California, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
UCLA Medical Center
Los Angeles, California, United States
Inland Rheumatology and Osteoporosis Medical Group
Upland, California, United States
Inland Rheumatology Clinical Trials, Inc.
Upland, California, United States
Asthma, Allergy, Arthritis and Lung Center
Daytona Beach, Florida, United States
Southeastern Arthritis Center
Gainesville, Florida, United States
Southeastern Community Pharmacy
Gainesville, Florida, United States
Southeastern Integrated Medical, PL, d/b/a Florida Medical Research Institute
Gainesville, Florida, United States
Southeastern lmaging & Diagnostics
Gainesville, Florida, United States
New Horizon Research Center
Miami, Florida, United States
Arthritis Associates
Orlando, Florida, United States
Millennium Research
Ormond Beach, Florida, United States
The Arthritis Center
Palm Harbor, Florida, United States
Advent Clinical Research Centers, Inc.
Pinellas Park, Florida, United States
Burnette & Silverfield, MDS PLC
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Grady Health Systems
Atlanta, Georgia, United States
Idaho Arthritis Center
Meridian, Idaho, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Beacon Medical Group Rheumatology
Granger, Indiana, United States
Indiana CTSI Clinical Research Center
Indianapolis, Indiana, United States
Investigational Drug Services
Indianapolis, Indiana, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
Johns Hopkins Outpatient Center
Baltimore, Maryland, United States
Johns Hopkins Outpatient Express Testing Center
Baltimore, Maryland, United States
Tufts Medical Center/ Center for Arthritis and Rheumatic Diseases
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
University of Michigan Health System,
Ann Arbor, Michigan, United States
Henry Ford Health System (Henry Ford Medical Center)
Detroit, Michigan, United States
Shores Rheumatology P.C
Saint Clair Shores, Michigan, United States
University of Nevada School of Medicine
Las Vegas, Nevada, United States
Albuquerque Clinical Trials
Albuquerque, New Mexico, United States
Arthritis and Osteoporosis Medical Associates, PLLC
Brooklyn, New York, United States
Feinstein Institute for Medical Research
Manhasset, New York, United States
NYU Center for Musculoskeletal Care
New York, New York, United States
Allergy/Immunology and Rheumatology
Rochester, New York, United States
The University of North Carolina Clinical and Translational Research Center
Chapel Hill, North Carolina, United States
The University of North Carolina Hospitals Investigational Drug Services
Chapel Hill, North Carolina, United States
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Joint and Muscle Medical Care
Charlotte, North Carolina, United States
Box Arthritis & Rheumatology of the Carolinas, PLLC
Charlotte, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Paramount Medical Research and Consulting, LLC
Middleburg Heights, Ohio, United States
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States
Clinical Research Center of Reading, LLP
Wyomissing, Pennsylvania, United States
Low Country Rheumatology, PA/Low Country Research
Charleston, South Carolina, United States
Arthritis Clinic
Jackson, Tennessee, United States
West Tennessee Research Institute
Jackson, Tennessee, United States
UT Southwestern Medical Center
Dallas, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Rheumatic Disease Clinical Research Center, LLC
Houston, Texas, United States
Accurate Clinical Research, Inc.
Houston, Texas, United States
Southwest Rheumatology Research, LLC
Mesquite, Texas, United States
The Seattle Arthritis Clinic
Seattle, Washington, United States
Tacoma Center for Arthritis Research, PS
Tacoma, Washington, United States
Mountain State Clinical Research
Clarksburg, West Virginia, United States
Framingham Centro Medico
La Plata, Buenos Aires, Argentina
Instituto CAICI S.R.L.
Rosario, Santa Fe Province, Argentina
Centro Medico Privado de Reumatologia
San Miguel de Tucumán, Tucumán Province, Argentina
Centro de Educación Medica e Investigaciones Clinicas "Norberto Quirno" CEMIC
C.a.b.a, , Argentina
Centro Polivalente de Asistencia e Investigación Clínica - CER- San Juan
San Juan, , Argentina
Centro de Estudios Reumatologicos
Santiago, RM, Chile
Centro Medico Prosalud
Santiago, RM, Chile
Sociedad Medica del Aparato Locomotor S.A. (SOMEAL)
Santiago, Santiago Metropolitan, Chile
Centro Integral de Reumatologia REUMALAB S.A.S.
Envigado, Antioquia, Colombia
Hospital Pablo Tobon Uribe
Medellín, Antioquia, Colombia
Mix Supplier S.A.
Envigado, Antioquia, Colombia, Colombia
Centro Integral de Reumatología del Caribe CIRCARIBE SAS
Barranquilla, Atlántico, Colombia
Congregacion de Hermanas Franciscanas Misioneras de Maria Auxiliadora- Clinica Asunción
Barranquilla, Atlántico, Colombia
Organizacion Clinica General del Norte S.A.
Barranquilla, Atlántico, Colombia
Farmamix Ltda.
Bogota, Distrito Capital, Cundimarca, Colombia
Centro Integral de Reumatologia e Inmunologia S.A.S.- CIREI S.A.S.
Bogota, Cundinamarca, Colombia
Riesgo De Fractura S.A
Bogota, Cundinamarca, Colombia
Servimed E.U
Bucaramanga, Santander Department, Colombia
Farmamix Ltda.
Bogotá, , Colombia
Charité - Universitaetsmedizin Berlin
Berlin, , Germany
Charité University Medicine Berlin. Schlosspark-Klinik
Berlin, , Germany
Universitaetsklinikum Koeln
Cologne, , Germany
Universitaetsklinikum Erlangen
Erlangen, , Germany
CIRI am Klinikum der Goethe-Universitaet
Frankfurt am Main, , Germany
Universitaetsklinikum Leipzig AoeR, Department fuer Innere Medizin
Leipzig, , Germany
Qualiclinic Kft.
Budapest, , Hungary
Debreceni Egyetem Orvos és Egeszsegtudomanyi Centrum
Debrecen, , Hungary
Bekes Megyei Kepviselo-testulet Pandy Kalman Korhaz Infektologia, Hepatologia es Immunologia
Gyula, , Hungary
Spitalul Clinic Republican
Chisinau, Md-2025, Moldova
Centro de Investigacion REUMED, Clinica Anglo Americana
San Isidro, Lima region, Peru
Investigaciones Clínicas SAC
Santiago de Surco, Lima region, Peru
Investigaciones Clinicas SAC
Surco, Lima region, Peru
Unidad de Investigación en Medicina Interna y Enfermedades Críticas
Arequipa, , Peru
NZOZ Centrum Reumatologiczne Indywidualna Specjalistyczna Praktyka Lekarska lek.med. Barbara Bazela
Elblag, , Poland
Medyczne Centrum Hetmanska - Indywidualna Specjalistyczna Praktyka Lekarska -
Poznan, , Poland
Prywatna Praktyka Lekarska Prof. UM Dr hab. med. Pawel Hrycaj
Poznan, , Poland
Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych
Warsaw, , Poland
University of Puerto Rico
Rio Piedras, , Puerto Rico
Division of Rheumatology, Allergy and Immunology
San Juan, , Puerto Rico
Spitalul Clinic Sf. Maria
Bucharest, , Romania
Spitalul Clinic Colentina
Bucharest, , Romania
Spitalul Clinic Jedetean de urgenta Cluj, Reumatologie
Cluj-Napoca, , Romania
Spitalul Clinic Judetean de Urgenta "Sf. Apostol Andrei"
Galati, , Romania
Dong-A University Medical Center 1
Busan, , South Korea
National Taiwan University Hospital
Taipei TOC, , Taiwan
Countries
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References
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Li C, Shoji S, Beebe J. Pharmacokinetics and C-reactive protein modelling of anti-interleukin-6 antibody (PF-04236921) in healthy volunteers and patients with autoimmune disease. Br J Clin Pharmacol. 2018 Sep;84(9):2059-2074. doi: 10.1111/bcp.13641. Epub 2018 Jun 25.
Wallace DJ, Strand V, Merrill JT, Popa S, Spindler AJ, Eimon A, Petri M, Smolen JS, Wajdula J, Christensen J, Li C, Diehl A, Vincent MS, Beebe J, Healey P, Sridharan S. Efficacy and safety of an interleukin 6 monoclonal antibody for the treatment of systemic lupus erythematosus: a phase II dose-ranging randomised controlled trial. Ann Rheum Dis. 2017 Mar;76(3):534-542. doi: 10.1136/annrheumdis-2016-209668. Epub 2016 Sep 26.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2011-000420-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BUTTERFLY
Identifier Type: OTHER
Identifier Source: secondary_id
B0151006
Identifier Type: -
Identifier Source: org_study_id