A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira®) In Combination With Methotrexate In Subjects With Active Rheumatoid Arthritis (REFLECTIONS B538-02).
NCT ID: NCT02480153
Last Updated: 2019-01-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
597 participants
INTERVENTIONAL
2015-06-25
2017-12-06
Brief Summary
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In an additional optional portion of the study, during open label Treatment Period 3 (TP3), a subset of subjects used a Prefilled Pen (PFP) to administer up to 3 injections of their study treatment (PF-06410293) at home.
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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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PF-06410293
PF-06410293
PF-06410293 will be administered with a uniform dose regimen, which is SC injection at a dose of 40 mg every other week, throughout the study treatment.
Adalimumab
Adalimumab
Adalimumab will be administered with a uniform dose regimen, which is SC injection at a dose of 40 mg every other week, throughout the study treatment.
Interventions
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PF-06410293
PF-06410293 will be administered with a uniform dose regimen, which is SC injection at a dose of 40 mg every other week, throughout the study treatment.
Adalimumab
Adalimumab will be administered with a uniform dose regimen, which is SC injection at a dose of 40 mg every other week, throughout the study treatment.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At least 6 tender (of 68 assessed) and 6 swollen (of 66 assessed) joints at screening and baseline.
* Hs-CRP equal or greater than 8 mg/L.
* Must have received methotrexate for at least 12 weeks and been on a stable dose for at least 4 weeks prior to the first study dose.
Exclusion Criteria
* Evidence of uncontrolled, clinically significant diseases, including moderate or severe heart failure (NYHA Class III/IV) or malignancy in the previous 5 years.
* History of infection requiring hospitalization or parenteral antimicrobial therapy within 6 months prior to first dose of study drug.
* May have received no more than 2 doses of one biologic therapy (other than adalimumab or lymphocyte depleting therapy).
* Any second DMARD must be washed out prior to the first study dose.
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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ArthroCare, Arthritis Care & Research P.C.
Gilbert, Arizona, United States
Arizona Arthritis & Rheumatology Associates, PC
Glendale, Arizona, United States
Arizona Arthritis & Rheumatology Associates, PC
Phoenix, Arizona, United States
St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare
Fullerton, California, United States
East Bay Rheumatology Medical Group, Inc.
San Leandro, California, United States
Westlake Medical Research
Thousand Oaks, California, United States
Inland Rheumatology Clinical Trials, Inc.
Upland, California, United States
Desert Valley Medical Group
Victorville, California, United States
Javed Rheumatology Associates, Inc
Newark, Delaware, United States
Arthritis and Rheumatic Disease Specialties
Aventura, Florida, United States
Robert W. Levin, MD, PA
Clearwater, Florida, United States
International Medical Research
Daytona Beach, Florida, United States
SIMED Arthritis Center
Gainesville, Florida, United States
Southeastern Integrated Medical, PL, d/b/a Florida Medical Research
Gainesville, Florida, United States
Rheumatology Associates of Central Florida, P.A.
Orlando, Florida, United States
Sarasota Arthritis Research Center
Sarasota, Florida, United States
Alastair C. Kennedy, MD
Vero Beach, Florida, United States
Indian River Primary Care
Vero Beach, Florida, United States
St Luke's Intermountain Research Center
Boise, Idaho, United States
St Luke' s Clinic
Meridian, Idaho, United States
Physician's Clinic of Iowa, P.C.
Cedar Rapids, Iowa, United States
Graves-Gilbert Clinic Bowling Green
Bowling Green, Kentucky, United States
The Center for Rheumatology and Bone Research
Wheaton, Maryland, United States
Bronson Internal Medicine and Rheumatology
Battle Creek, Michigan, United States
North Mississippi Medical Clinics, Inc. - Clinical Research
Tupelo, Mississippi, United States
Physician Research Collaboration, LLC
Lincoln, Nebraska, United States
Westroads Clinical Research, Inc.
Omaha, Nebraska, United States
Arthritis, Rheumatic & Back Disease Associates, P.A.
Voorhees Township, New Jersey, United States
Manhattan Medical Research
New York, New York, United States
Buffalo Rheumatology and Medicine PLLC
Orchard Park, New York, United States
Physicians East PA
Greenville, North Carolina, United States
Cincinnati Rheumatic Disease Study Group, Inc.
Cincinnati, Ohio, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Clinical Research of Reading, LLC
Wyomissing, Pennsylvania, United States
Low Country Rheumatology, PA
Charleston, South Carolina, United States
Regional Health Clinical Research
Rapid City, South Dakota, United States
Regional Medical Clinic - Rheumatology
Rapid City, South Dakota, United States
West Tennessee Research Institute
Jackson, Tennessee, United States
Ramesh C Gupta, M.D.
Memphis, Tennessee, United States
Amarillo Center for Clinical Research, Ltd.
Amarillo, Texas, United States
Austin Regional Clinic
Austin, Texas, United States
Metroplex Clinical Research Center
Dallas, Texas, United States
The Clinical Research Institute of Houston, LLC
Houston, Texas, United States
Accurate Clinical Research
League City, Texas, United States
Southwest Rheumatology Research, LLC
Mesquite, Texas, United States
Northwest Diagnostic Clinic, PA
Shenandoah, Texas, United States
Center for Arthritis and Rheumatic Diseases, P.C.
Chesapeake, Virginia, United States
Wenatchee Valley Hospitals & Clinics
Wenatchee, Washington, United States
Rheumatology and Pulmonary Clinic
Beckley, West Virginia, United States
Paradise Arthritis & Rheumatology Pty Ltd
Southport, Queensland, Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia
RK Will Pty Ltd
Victoria Park, Western Australia, Australia
EDUMED Educação em Saúde S/S Ltda
Curitiba, Paraná, Brazil
MHAT Plovdiv AD
Plovdiv, , Bulgaria
University Multiprofile Hospital for Active Treatment (UMHAT) Kaspela EOOD
Plovdiv, , Bulgaria
UMHAT "Sv. Ivan Rilski" EAD
Sofia, , Bulgaria
University Multiprofile Hospital for Active Treatment "Sv. Ivan Rilski" EAD
Sofia, , Bulgaria
Fundacion Instituto de Reumatologia Fernando Chalem
Bogotá, , Colombia
Lekarna Na vrsku
Bruntál, , Czechia
Revmatologie Bruntal, s.r.o.
Bruntál, , Czechia
L.K.N. Arthrocentrum, s.r.o.
Hlučín, , Czechia
Lekarna Vesalion
Ostrava, , Czechia
Benu Lekarna
Pardubice, , Czechia
CCBR-SYNARC, a.s.
Pardubice, , Czechia
Revmatologicky ustav
Prague, , Czechia
Lekarna Hradebni s.r.o.
Uherské Hradiště, , Czechia
MEDICAL PLUS, s.r.o.
Uherské Hradiště, , Czechia
Innomedica OÜ
Tallinn, , Estonia
East Tallinn Central Hospital
Tallinn, , Estonia
LTD "Unimed Adjara"
Batumi, Adjara, Georgia
Unimedi Kakheti Ltd, Telavi Referral Hospital
Telavi, Kakheti, Georgia
V.Tsitlanadze Scientifically-Practical Rheumatology Center LTD
Tbilisi, , Georgia
V.Tsitlanadze Scientifically-Practical Rheumatology Center
Tbilisi, , Georgia
LTD Israeli-Georgian Medical Research Clinic Helsicore"
Tbilisi, , Georgia
LTD Cardio-Reanimation Center
Tbilisi, , Georgia
Tbilisi Heart and Vascular Clinic LTD
Tbilisi, , Georgia
LTD Altravita
Tbilisi, , Georgia
LTD.MediClubGeorgia
Tbilisi, , Georgia
JSC Medical Corporation Evex
Tbilisi, , Georgia
Schlosspark-Klinik
Berlin, , Germany
Gemeinschaftspraxis Dr. von Hinüber/Dr. Demary
Hildesheim, , Germany
Klinikum der Universität München
München, , Germany
Praxiszentrum St. Bonifatius
München, , Germany
Rheumapraxis Dr. Martin Welcker und Kollegen
Planegg, , Germany
Knappschaftsklinikum Saar GmbH
Püttlingen, , Germany
Rheumazentrum Ratingen
Ratingen, , Germany
Debreceni Egyetem Klinikai Központ
Debrecen, Hajdú-Bihar, Hungary
Qualiclinic Kft.
Budapest, , Hungary
Vital Medical Center Orvosi es Fogorvosi Kozpont
Veszprém, , Hungary
Anjo Kosei Hospital
Anjo-shi, Aichi-ken, Japan
Inoue Hospital
Takasaki, Gunma, Japan
National Hospital Organization Asahikawa Medical Center
Asahikawa, Hokkaido, Japan
Katayama Orthopaedic Rheumatology Clinic
Asahikawa, Hokkaido, Japan
Sapporo City General Hospital
Sapporo, Hokkaido, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Matsubara Mayflower Hospital
Katō, Hyōgo, Japan
National Hospital Organization Nagasaki Medical Center
Ōmura, Nagasaki, Japan
Saitama Medical Center
Kawagoe, Saitama, Japan
Hirose Clinic
Tokorozawa, Saitama, Japan
Kondo clinic for rheumatism and orthopaedics
Fukuoka, , Japan
National Hospital Organization Kyushu Medical Center
Fukuoka, , Japan
LSMUL Kauno klinikos
Kaunas, , Lithuania
Klaipedos universitetine ligonine
Klaipėda, , Lithuania
Vilniaus universiteto ligonines Santariskiu klinikos
Vilnius, , Lithuania
Consultorio Medico Privado de Reumatologia
Mexicali, Estado de Baja California, Mexico
Consultorio de Reumatologia
Mexico City, , Mexico
MedLab
Timaru, South Canterbury, New Zealand
Timaru Hospital
Timaru, South Canterbury, New Zealand
Timaru Rheumatology Studies
Timaru, South Canterbury, New Zealand
Waikato Hospital
Hamilton, , New Zealand
Wellington Hospital, Capital Coast District Health Board
Wellington, , New Zealand
Unidad de Investigacion en Medicina Interna y Enfermedades Criticas
Arequipa, , Peru
Oficina administrativa
Arequipa, Arequipa, , Peru
ABK REUMA SRL-Medicentro Biociencias Peru SRL
Lima, , Peru
Clinica Medica Cayetano Heredia
Lima, , Peru
Centro de Investigación para el Estudio de Enfermedades Reumáticas
Lima, , Peru
Instituto de Ginecología y Reproducción & Cirugía Mínimamente Invasiva
Lima, , Peru
Oficina Administrativa
Lima Lima, , Peru
Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk
Bialystok, , Poland
NZOZ Zdrowie Osteo-Medic s.c.
Bialystok, , Poland
Centrum Kliniczno-Badawcze J.Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka Partnerska
Elblag, , Poland
NZOZ Centrum Reumatologiczne Indywidualna Specjalistyczna Praktyka Lekarska Lek. med. Barbara Bazela
Elblag, , Poland
Synexus Polska Sp. z o.o. Oddzial w Gdyni
Gdynia, , Poland
Synexus Polska Sp. z o.o. Oddzial w Katowicach
Katowice, , Poland
Centrum Medyczne Pratia Katowice
Katowice, , Poland
Zespol Poradni Specjalistycznych "REUMED" Filia nr 2
Lublin, , Poland
NZOZ Lecznica MAK-MED. S.C.
Nadarzyn, , Poland
Prywatna Praktyka Lekarska Prof. UM Dr Hab. Med. Pawel Hrycaj
Poznan, , Poland
Niepubliczny Zaklad Opieki Zdrowotnej ''Nasz Lekarz''
Torun, , Poland
Synexus Polska Sp. z o.o. Oddzial w Warszawie
Warsaw, , Poland
Centrum Medyczne AMED
Warsaw, , Poland
MTZ Clinical Research Sp. z o.o.
Warsaw, , Poland
''Rheuma Medicus'' Zakład Opieki Zdrowotnej
Warsaw, , Poland
Synexus Polska Sp. z o.o. Oddział we Wroclawiu
Wroclaw, , Poland
GBUZ Republican hospital n.a. V.A. Baranov
Petrozavodsk, Republic of Karelia, Russia
LLC Alliance Biomedical Ural group
Izhevsk, , Russia
GAUZ of Kemerovo Region "Regional clinical hospital for war veterans"
Kemerovo, , Russia
GMU Kursk Regional Clinical Hospital of the Healthcare Committee of the Kursk Region
Kursk, , Russia
Municipal Clinical Hospital No. 1 Named after N.I. Pirogov
Moscow, , Russia
GBUZ of city of Moscow City clinical hospital n.a. A.K.Eramishantsev of Ministry of Healthcare of
Moscow, , Russia
Orenburg State Medical Academy
Orenburg, , Russia
Regional Clinical Hospital
Orenburg, , Russia
GBOU VPO Ryazan State Medical University Named after Academician I.P. Pavlov
Ryazan, , Russia
GBU of Ryazan region Regional clinical cardiology dispanser
Ryazan, , Russia
Spb GBUZ "Clinical rheumatology hospital # 25" City CDC prevention of osteoporosis
Saint Petersburg, , Russia
GUZ " Regional clinical hospital"
Saratov, , Russia
GBUZ VO Regional clinical hospital
Vladimir, , Russia
GBKUZ of Yaroslavl region "City hospital n. a. N.A. Semashko"
Yaroslavl, , Russia
Institute of Rheumatology
Belgrade, , Serbia
Military Medical Academy,
Belgrade, , Serbia
Institute for Treatment and Rehabilitation Niska Banja
Niška Banja, , Serbia
Special Hospital for Rheumatic Diseases Novi Sad
Novi Sad, , Serbia
Charlotte Maxeke Johannesburg Academic Hospital
Johannesburg, Gauteng, South Africa
Clinresco Centres (Pty) Ltd
Kempton Park, Gauteng, South Africa
St. Augustine's Hospital
Durban, KwaZulu-Natal, South Africa
Arthritis Clinical Research Trials, Dr. C.E Spargo and Dr. R.B Bhorat Practice
Cape Town, Western Cape, South Africa
Panorama Medical Centre
Cape Town, Western Cape, South Africa
Chonnam National University Hospital
Gwangju, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Konkuk University Medical Center
Seoul, , South Korea
Hanyang University Seoul Hospital
Seoul, , South Korea
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, Spain
Hospital Universitario Cruces
Barakaldo, Vizcaya, Spain
Hospital Universitario A Coruña
A Coruña, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Hospital Infanta Luisa
Seville, , Spain
Chung Shan Medical University Hospital
Taichung, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
Taipei Medical University Hospital
Taipei, , Taiwan
Kyivska miska klinichna likarnia #6
Kyiv, , Ukraine
Lvivskyi oblasnyi klinichnyi diahnostychnyi tsentr,
Lviv, , Ukraine
Komunalna 4-a miska klinichna likarnia m. Lvova,
Lviv, , Ukraine
Komunalnyi zaklad okhorony zdorovia "Kharkivska miska klinichna likarnia #8"
M. Kharkiv, , Ukraine
Komunalnyi zaklad Kyivskoi oblasnoi rady "Kyivska oblasna klinichna likarnia",
M. Kyiv,, , Ukraine
Bahatoprofilnyi medychnyi tsentr (Universytetska klinika #1)
Odesa, , Ukraine
Komunalnyi zaklad Sumskoi oblasnoi rady "Sumska oblasna klinichna
Sumy, , Ukraine
Vinnytska oblasna klinichna likarnia im. M.I.Pyrohova revmatolohichne viddilennia
Vinnytsia, , Ukraine
Komunalna ustanova "Zaporizka oblasna klinichna likarnia" Zaporizkoi oblasnoi rady
Zaporizhzhia, , Ukraine
Basingstoke and North Hampshire Hospital, Hampshire Hospitals NHS Foundation Trust
Basingstoke, Hampshire, United Kingdom
Arrowe Park Hospital, Wirral University Teaching Hospitals NHS Foundation Trust
Metropolitan Borough of Wirral, Merseyside, United Kingdom
Royal United Hospital Bath NHS Foundation Trust ,Royal National Hospital for Rheumatic Diseases
Bath, Somerset, United Kingdom
The Leeds Institute of Rheumatic and Musculoskeletal Medicine
Leeds, WEST Yorkshire, United Kingdom
Countries
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References
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Kay J, Bock AE, Rehman M, Zhang W, Zhang M, Iikuni N, Alvarez DF. Use of multibiomarker disease activity scores in biosimilarity studies for the treatment of patients with rheumatoid arthritis. RMD Open. 2022 Sep;8(2):e002423. doi: 10.1136/rmdopen-2022-002423.
Fleischmann RM, Bock AE, Zhang W, Godfrey CM, Vranic I, Cronenberger C, Dokoupilova E. Usability Study of PF-06410293, an Adalimumab Biosimilar, by Prefilled Pen: Open-Label, Single-Arm, Sub-Study of a Phase 3 Trial in Patients with Rheumatoid Arthritis. Rheumatol Ther. 2022 Jun;9(3):839-850. doi: 10.1007/s40744-022-00439-8. Epub 2022 Mar 18.
Fleischmann RM, Alvarez DF, Bock AE, Cronenberger C, Vranic I, Zhang W, Alten R. Long-term efficacy, safety, and immunogenicity of the adalimumab biosimilar, PF-06410293, in patients with rheumatoid arthritis after switching from reference adalimumab (Humira(R)) or continuing biosimilar therapy: week 52-92 data from a randomized, double-blind, phase 3 trial. Arthritis Res Ther. 2021 Sep 25;23(1):248. doi: 10.1186/s13075-021-02626-4.
Fleischmann RM, Alvarez DF, Bock AE, Cronenberger C, Vranic I, Zhang W, Alten R. Randomised study of PF-06410293, an adalimumab (ADL) biosimilar, compared with reference ADL for the treatment of active rheumatoid arthritis: results from weeks 26-52, including a treatment switch from reference ADL to PF-06410293. RMD Open. 2021 Apr;7(2):e001578. doi: 10.1136/rmdopen-2021-001578.
Huizinga TWJ, Torii Y, Muniz R. Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity. Rheumatol Ther. 2021 Mar;8(1):41-61. doi: 10.1007/s40744-020-00259-8. Epub 2020 Dec 1.
Fleischmann RM, Alten R, Pileckyte M, Lobello K, Hua SY, Cronenberger C, Alvarez D, Bock AE, Sewell KL. A comparative clinical study of PF-06410293, a candidate adalimumab biosimilar, and adalimumab reference product (Humira(R)) in the treatment of active rheumatoid arthritis. Arthritis Res Ther. 2018 Aug 15;20(1):178. doi: 10.1186/s13075-018-1676-y.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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B5381002, REFLECTIONS B538-02
Identifier Type: -
Identifier Source: secondary_id
2014-000352-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ADALIMUMAB
Identifier Type: OTHER
Identifier Source: secondary_id
B5381002
Identifier Type: -
Identifier Source: org_study_id
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