A Pharmacokinetic/Pharmacodynamic Study Comparing PF-05280586 To Rituximab In Subjects With Active Rheumatoid Arthritis With An Inadequate Response To TNF Inhibitors (REFLECTIONS B328-01)
NCT ID: NCT01526057
Last Updated: 2019-11-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
220 participants
INTERVENTIONAL
2012-03-20
2014-05-07
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
QUADRUPLE
Study Groups
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A - PF-05280586
PF-05280586
1000 mg, IV on days 1 and 15
B - Rituximab EU
MabThera
1000 mg, IV on days 1 and 15
C- Rituximab-US
Rituxan
1000 mg, IV on days 1 and 15
Interventions
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PF-05280586
1000 mg, IV on days 1 and 15
MabThera
1000 mg, IV on days 1 and 15
Rituxan
1000 mg, IV on days 1 and 15
Eligibility Criteria
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Inclusion Criteria
* Meets Class I, II or III of the ACR 1991 Revised Criteria
* RA seropositivity
* Stable dose of methotrexate
* Inadequate response to TNF inhibitors
Exclusion Criteria
* History of active TB infection
* Known or screen test positive for specific viruses or indicators of viral infection
18 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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University of Alabama at Bermingham
Birmingham, Alabama, United States
University of Alabama at Birmingham - Arthritis Clinical Intervention Program (ACIP) SRC 076
Birmingham, Alabama, United States
Rheumatology Associates of North Alabama, PC
Huntsville, Alabama, United States
ArthroCare, Arthritis Care & Research, PC
Gilbert, Arizona, United States
Mercy Clinic Hot Springs Communities
Hot Springs, Arkansas, United States
UCLA David Geffen School of Medicine
Los Angeles, California, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
Desert Medical Advances
Palm Desert, California, United States
Advances In Medicine
Rancho Mirage, California, United States
New England Research Assoc. LLC
Trumbull, Connecticut, United States
Arthritis Associates
Orlando, Florida, United States
University of South Florida - College of Medicine, Frank and Carol Morsani Center
Tampa, Florida, United States
Loyola Center for Health at Burr Ridge
Burr Ridge, Illinois, United States
Loyola Medical Medical Center Outpatient Center
Maywood, Illinois, United States
Loyola University Medical Center Pharmacy
Maywood, Illinois, United States
Illinois Bone and Joint Institute
Morton Grove, Illinois, United States
Loyola Center for health at Oakbrook Terrace North
Oakbrook Terrace, Illinois, United States
Bluegrass Community Research, Inc.
Lexington, Kentucky, United States
Klein & Associates, M.D., P.A.
Cumberland, Maryland, United States
Klein & Associates, M.D., P.A.
Hagerstown, Maryland, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, United States
UMass Memorial Medical Center - Memorial Campus
Worcester, Massachusetts, United States
UMass Memorial Medical Center-Rheumatology Center-Memorial Campus
Worcester, Massachusetts, United States
Bronson Internal Medicine & Rheumatology
Battle Creek, Michigan, United States
Rheumatology/Arthritis Center
Lansing, Michigan, United States
University Of Nevada School Of Medicine
Las Vegas, Nevada, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
North Shore-LIJ Health System - Division of Rheumatology and Allergy-Clinical Immunology
Great Neck, New York, United States
Box Arthritis & Rheumatology of the Carolinas, PLLC
Charlotte, North Carolina, United States
Hickory Family Practice Associates
Hickory, North Carolina, United States
PMG Research of Hickory, LLC - PI's Main Office (Subject visit, IP Storage, Infusion, & Lab Draws)
Hickory, North Carolina, United States
PMG Research of Hickory
Hickory, North Carolina, United States
Cincinnati Rheumatic Disease Study Group, Inc.
Cincinnati, Ohio, United States
Health Research of Oklahoma
Oklahoma City, Oklahoma, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
The Arthritis Group
Philadelphia, Pennsylvania, United States
Clinical Research Center of Reading, LLP
Wyomissing, Pennsylvania, United States
Arthritis Associates, PLLC
Hixson, Tennessee, United States
Arthritis Clinic
Jackson, Tennessee, United States
West Tennessee Research Institute
Jackson, Tennessee, United States
Metroplex Clinical Research Center
Dallas, Texas, United States
Center For Clinical Trials Of Houston
Houston, Texas, United States
Southwest Rheumatology Research LLC.
Mesquite, Texas, United States
Rheumatology Research Unit
Maroochydore, Queensland, Australia
The Queen Elizabeth Hospital, Department of Rheumatology
Woodville South, South Australia, Australia
St. Vincent's Hospital (Melbourne)
Fitzroy, Victoria, Australia
Pharmacie Matte et Petit
Québec, Quebec, Canada
Centre de Rhumatologie St-Louis
Québec, Quebec, Canada
Centre de Rhumatologie de l'Est du Quebec
Rimouski, Quebec, Canada
Clinique Medicale du Phare
Rimouski, Quebec, Canada
Centre de Recherche Musculo-Squelettique
Trois-Rivières, Quebec, Canada
Clinica Medellin S.A Sede Centro
Medellín, Antioquia, Colombia
Mix Supplier S.A
Medellín, Antioquia, Colombia
Rodrigo Botero S.A.S.
Medellín, Antioquia, Colombia
Cediul S.A.
Barranquilla, Atlántico, Colombia
Centro de Reumatologia y Ortopedia
Barranquilla, Atlántico, Colombia
Clinica Bonnadona - Prevenir S.A.
Barranquilla, Atlántico, Colombia
Clinica de la Costa Ltdz.
Barranquilla, Atlántico, Colombia
IPS Centro Integral de Reumatologia del Cairbe, CIRCARIBE S.A.S.
Barranquilla, Atlántico, Colombia
Sabbag Radiologos Ltda.
Barranquilla, Atlántico, Colombia
Cerid S.A.
Barranquilla, Colombia, Atlántico, Colombia
Congregacion de las Hemanas Franciscanas Misioneras de Maria Auxiliadora - Clinica La Asuncion
Barranquilla, Colombia, Atlántico, Colombia
IPS Clinica General del Norte S.A.
Barranquilla, Colombia, Atlántico, Colombia
Schlosspark-Klinik GMBH, Internal Medicine II
Berlin, , Germany
The Chaim Sheba Medical Center Department of Internal Medicine B
Ramat Gan, , Israel
Cliditer, S.A. de C.V.
México, D.F., Mexico
Private Office
Guadalajara, Jalisco, Mexico
Centro De Investigacion Y Atencion Integral Durango CIAID
Durango, , Mexico
Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi S.C.
San Luis Potosí City, , Mexico
LLC CDCR "Healthy Joints"
Novosibirsk, Novosibirsk Oblast, Russia
GBUZ City Clinical Hospital #7
Kazan', Tatarstan Republic, Russia
State Institution of Healthcare "Regional Clinical Hospital for Wars' Veterans"
Kemerovo, , Russia
State Budgetary Institution of Healthcare of Nizhegorodskiy Region
Nizhny Novgorod, , Russia
St. Petersburg state Healthcare lnstitution 'Clinical Rheumatology Hospital No25
Saint Petersburg, , Russia
Llc Ava-Peter
Saint Petersburg, , Russia
State Institute of Healthcare Samara Regional Clinical Hospital named after M.I.Kalinin
Samara, , Russia
Regional State Budget Institution of Healthcare "Tomsk Regional Clinical Hospital"
Tomsk, , Russia
Panorama Medical Centre
Panorama, CAPE TOWN, South Africa
Dr. Jan Fourie Medical Centre
Dundee, KwaZulu-Natal, South Africa
Bexley Wing - St. James's University Hospital
Leeds, UK, United Kingdom
Pharmacy Department, Leeds General Infirmary, Leeds Teaching Hospitals NHS Trust
Leeds, , United Kingdom
"The University of Leeds,
Leeds, , United Kingdom
Pharmacy Dispensing - Bexley Wing - St. James's University Hospital
Leeds, , United Kingdom
Whipps Cross University Hospital
London, , United Kingdom
Countries
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References
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Williams JH, Hutmacher MM, Zierhut ML, Becker JC, Gumbiner B, Spencer-Green G, Melia LA, Liao KH, Suster M, Yin D, Li R, Meng X. Comparative assessment of clinical response in patients with rheumatoid arthritis between PF-05280586, a proposed rituximab biosimilar, and rituximab. Br J Clin Pharmacol. 2016 Dec;82(6):1568-1579. doi: 10.1111/bcp.13094. Epub 2016 Sep 22.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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ICON 9002/010
Identifier Type: -
Identifier Source: secondary_id
2011-002896-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
B3281001
Identifier Type: -
Identifier Source: org_study_id
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