A Study of PF-06438179 (Infliximab-Pfizer) and Infliximab in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis (REFLECTIONS B537-02).
NCT ID: NCT02222493
Last Updated: 2018-05-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
650 participants
INTERVENTIONAL
2014-08-26
2017-06-01
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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PF-06438179
PF-06438179
PF-06438179 will be administered by intravenous infusion at an initial dose of 3 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.
Infliximab
Infliximab
Infliximab will be administered by intravenous infusion at an initial dose of 3 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.
Interventions
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PF-06438179
PF-06438179 will be administered by intravenous infusion at an initial dose of 3 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.
Infliximab
Infliximab will be administered by intravenous infusion at an initial dose of 3 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.
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 10 mg/L.
Must have received methotrexate for at least 12 weeks and be on a stable dose for at least 4 weeks.
Exclusion Criteria
Evidence or history of moderate or severe heart failure (NYHA Class III/IV)
Infection requiring hospitalization or parenteral antimicrobial therapy judged clinically significant by the investigator within 6 months prior to first dose of study drug.
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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Achieve Clinical Research, LLC
Birmingham, Alabama, United States
Clinical and Translational Research Center of Alabama, PC
Tuscaloosa, Alabama, United States
Sun Valley Arthritis Center, Ltd.
Peoria, Arizona, United States
Arizona Arthritis & Rheumatology Associates, P.C.
Phoenix, Arizona, United States
St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare
Fullerton, California, United States
Arthritis & Osteoporosis Medical Center
La Palma, 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
International Medical Research
Daytona Beach, Florida, United States
Daytona Beach, Florida, United States
San Marcus Research Clinic, Inc.
Miami, Florida, United States
Advance Medical Research Services Corporation
Miami, 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
Harbin Clinic
Rome, Georgia, United States
Advanced Clinical Research
Meridian, Idaho, United States
Methodist Medical Center of IL
Peoria, Illinois, United States
Physician's Clinic of Iowa, P.C.
Cedar Rapids, Iowa, United States
Gilbert-Graves Clinic
Bowling Green, Kentucky, United States
Graves-Gilbert Clinic Bowling Green
Bowling Green, Kentucky, United States
Ochsner Clinic Baton Rouge
Baton Rouge, Louisiana, United States
Arthritis and Diabetes Clinic, Inc.
Monroe, Louisiana, United States
The Center for Rheumatology and Bone Research
Wheaton, Maryland, United States
Western Michigan University Homer Stryker MD School of Medicine Center for Clinical Research
Battle Creek, Michigan, United States
Arthritis, Rheumatic & Back Disease Associates
Voorhees Township, New Jersey, United States
Trinity Health Center-Medical Arts
Minot, North Dakota, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Clinical Research Center 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
Rapid City, South Dakota, United States
West Tennessee Research Institute
Jackson, Tennessee, United States
Ramesh C Gupta, MD
Memphis, Tennessee, United States
Austin Regional Clinic
Austin, Texas, United States
Metroplex Clinical Research Center
Dallas, Texas, United States
Accurate Clinical Research, Inc.
Houston, Texas, United States
Accurate Clinical Research
Nassau Bay, Texas, United States
Pharmacy Services, Sentara Leigh Hospital
Norfolk, Virginia, United States
Sentara Medical Group, Clinical Research
Norfolk, Virginia, United States
The Seattle Arthritis Clinic
Seattle, Washington, United States
Gold Coast Private Hospital Pty Ltd
Southport, Queensland, Australia
HPS Pharmacies
Southport, Queensland, Australia
Paradise Arthritis and Rheumatology Pty Ltd
Southport, Queensland, Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia
CliniPath Pathology
Osborne Park, Western Australia, Australia
R.K. Will Pty Ltd
Victoria Park, Western Australia, Australia
Clinical Center University of Sarajevo
Sarajevo, Kanton Sarajevo, Bosnia and Herzegovina
General Hospital "Prim.dr.Abdulah Nakas"
Sarajevo, Kanton Sarajevo, Bosnia and Herzegovina
University Clinical Center Tuzla
Tuzla, Tuzlanski Kanton, Bosnia and Herzegovina
University Hospital Clinical Center Banja Luka
Banja Luka, , Bosnia and Herzegovina
CETI - Centro de Estudos em Terapias Inovadoras
Curitiba, Paraná, Brazil
Hospital Israelita Albert Einstein
São Paulo, , Brazil
Multiprofile Hospital for Active Treatment Trimontium OOD
Plovdiv, , Bulgaria
University Multiprofile Hospital for Active Treatment (UMHAT) "Kaspela" EOOD
Plovdiv, , Bulgaria
University Multiprofile Hospital for Active Treatment (UMHAT) "Sv. Ivan Rilski" EAD
Sofia, , Bulgaria
Clinical Research and Arthritis Center
Windsor, Ontario, Canada
CCBR Czech Brno, s.r.o.
Brno, , Czechia
Lekarna Lancier, s.r.o.
Brno, , Czechia
BENU Lekarna
Pardubice, , Czechia
CCBR-SYNARC a.s.
Pardubice, , Czechia
CCBR Czech Prague, s.r.o.
Prague, , Czechia
Lekarna U Robina, s.r.o.
Prague, , Czechia
Lekarna Hradebni s.r.o.
Uherské Hradiště, , Czechia
MEDICAL PLUS, s.r.o.
Uherské Hradiště, , Czechia
LTD Tbilisi Central Hospital
Tbilisi, , Georgia
LTD Unimedi Kakheti
Tbilisi, , Georgia
Tbilisi Heart and Vascular Clinic LTD
Tbilisi, , Georgia
LTD MediClubGeorgia
Tbilisi, , Georgia
LTD Adapti
Tbilisi, , Georgia
LTD Medulla" Chemotherapy and Immunotherapy Clinic
Tbilisi, , Georgia
Schlosspark-Klinik
Berlin, , Germany
Klinikum der Universität München
München, , Germany
Elisabeth-Klinik gGmbH
Olsberg, , Germany
Knappschaftsklinikum Saar GmbH
Püttlingen, , Germany
Rheumazentrum Ratingen
Ratingen, , Germany
Clínica Médica Especializada en Medicina Interna y Reumatología
Guatemala City, , Guatemala
Clínica Médica especializada en Medicina Interna
Guatemala City, , Guatemala
Centro de Nutricion y Rehabilitacion Cardiorespiratoria, S.A. (NUCARE)
Guatemala City, , Guatemala
Therapeutic Research Institute and Lab S.A
Guatemala City, , Guatemala
DRC Gyógyszervizsgáló Központ Kft.
Balatonfüred, , Hungary
Qualiclinic Kft.
Budapest, , Hungary
Rambam Health Care Campus
Haifa, , Israel
Hadassah Medical Organization, Hadassah Medical Center, Ein-Karem
Jerusalem, , Israel
Meir Medical Center
Kfar Saba, , Israel
Anjo Kosei Hospital
Anjo-shi, Aichi-ken, Japan
Aso Iizuka Hospital
Iiduka, Fukuoka, Japan
Inoue Hospital
Takasaki, Gunma, Japan
Mazda Hospital
Aki-gun, Hiroshima, Japan
Sapporo City General Hospital
Sapporo, Hokkaido, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Matsubara Mayflower Hospital
Katoh, Hyōgo, Japan
National Hospital Organization Sagamihara National Hospital
Sagamihara, Kanagawa, Japan
Yokohama Minami Kyosai Hospital
Yokohama, Kanagawa, Japan
National Hospital Organization Nagasaki Medical Center
Ōmura, Nagasaki, Japan
Sasebo Chuo Hospital
Sasebo, Nagasaki, Japan
Kurashiki Sweet Hospital
Kurashiki, Okayama-ken, Japan
Yuaikai Tomishiro Central Hospital
Tomigusuku, Okinawa, Japan
Saitama Medical Center
Kawagoe-shi, Saitama, Japan
Hirose Clinic
Tokorozawa-shi, Saitama, Japan
National Hospital Organization Shizuoka Medical Center
Sunto-gun, Shizuoka, Japan
St. Luke's International Hospital
Chuo-ku, Tokyo, Japan
Toho University Ohashi Medical Center
Meguro-ku, Tokyo, Japan
Showa University Hospital
Shinagawa-ku, Tokyo, Japan
National Hospital Organization Chiba-East Hospital
Chiba, , Japan
Kondo clinic for rheumatism and orthopaedics
Fukuoka, , Japan
National Hospital Organization Kyushu Medical Center
Fukuoka, , Japan
Kumamoto Orthopaedic Hospital
Kumamoto, , Japan
Jordan Hospital
Amman, , Jordan
King Abdullah University Hospital
Irbid, , Jordan
LSMUL Kauno klinikos
Kaunas, , Lithuania
Centro de Alta Especialidad en Reumatología e Investigación del Potosí, S.C.
San Luis de Potosí, SAN LUIS de Potosi, Mexico
Unidad de Investigaciones Reumatológicas A.C - Hospital Central "Dr. Ignacio Morones Prieto"
Zona Universitaria, SAN LUIS de Potosi, Mexico
Unidad Reumatologica Las Americas S.C.P
Mérida, Yucatán, Mexico
El Ayachi Hospital
Salé, , Morocco
Groupe Radiologique de Salé
Salé, , Morocco
Laboratoire les Arcades d'Analyses Médicales
Salé, , Morocco
Hospital María Auxiliadora - Centro de Investigaciones Medicas
San Juan de Miraflores, Lima region, Peru
Instituto de Ginecología y Reproducción & Cirugía Mínimamente Invasiva
Santiago de Surco, Lima region, Peru
Centro de diagnóstico por imágenes, Radiología General y Especial
Arequipa, , Peru
Unidad de Investigación en Medicina Interna y Enfermedades Críticas
Arequipa, , Peru
Centro de Investigación Reumatología CAA
Lima, , Peru
Clinica Medica Cayetano Heredia
Lima, , Peru
Servicio de Inmunología y Reumatología
Lima, , Peru
Mary Mediatrix Medical Center
Lipa City, Batangas, Philippines
Southern Philippines Medical Center
Davao City, Davao DEL SUR, Philippines
Makati Medical Center
Makati City, National Capital Region, Philippines
Medical Center Manila
Manila, , Philippines
Philippine General Hospital
Manila, , Philippines
St. Luke's Medical Center
Quezon, , Philippines
Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w Bydgoszczy
Bydgoszcz, , Poland
Szpital Specjalistyczny im. J. Dietla Malopolskie Centrum Reumatologii Immunologii i Rehabilitacji
Krakow, , Poland
NZOZ Lecznica MAK-MED. S.C.
Nadarzyn, , Poland
Twoja Przychodnia - Centrum Medyczne Nowa Sol
Nowa Sól, , Poland
MTZ Clinical Research Sp. z o.o.
Warsaw, , Poland
Spitalul Clinic Judetean de Urgenta Galati "Sf. Apostol Andrei"
Galati, , Romania
Spitalul Clinic de Recuperare Iasi
Iași, , Romania
Spitalul Clinic Judetean de Urgenta Targu Mures
Târgu Mureş, , Romania
GBUZ "Republican hospital n.a. V.A.Baranov"
Petrozavodsk, Republic of Karelia, Russia
GAUZ of Kemerovo Region "Regional clinical hospital for war veterans"
Kemerovo, , Russia
KGBUZ "Krasnoyarsk Interdistrict Clinical Hospital #20 n.a. I.S.Berzon"
Krasnoyarsk, , Russia
Krasnoyarsk State Medical University n.a.Prof.V.F.Voyno-Yasenetsky
Krasnoyarsk, , Russia
GMU " Kursk regional clinical hospital" of the Committee of Healthcare of the Kursk region
Kursk, , Russia
GBUZ of city of Moscow
Moscow, , Russia
GBOU VPO "Ryazan State medical university n.a. academician I.P.Pavlov"
Ryazan, , Russia
GBOUVPO "Ryazan State Medical University n.a. Academician I.P.Pavlov"
Ryazan, , Russia
GBU of Ryazan region "Regional clinical cardiology dispanser"
Ryazan, , Russia
GBOU of Ryazan region "Regional clinical hospital"
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
Clinical Hospital Center Bezanijska Kosa
Belgrade, , Serbia
Military Medical Academy
Belgrade, , Serbia
Institute for Treatment and Rehabilitation "Niska Banja"
Niška Banja, , Serbia
Charlotte Maxeke Johannesburg Academic Hospital
Johannesburg, Gauteng, South Africa
Jakaranda Hospital
Pretoria, Gauteng, South Africa
Emmed Research
Pretoria, Gauteng, South Africa
Arthritis Clinical Research Unit
Cape Town, Western Cape, South Africa
Vincent Pallotti Hospital
Cape Town, Western Cape, South Africa
Chungnam National University Hospital
Daejeon, , South Korea
Chonnam National University Hospital
Gwangju, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Hanyang University Seoul Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Konkuk University Medical Center
Seoul, , South Korea
Mohamed Kassab Institute of orthopedics
Manouba, , Tunisia
Rabta Hospital
Tunis, , Tunisia
Derzhavna ustanova "Ukrainskyi derzhavnyi naukovo-doslidnyi instytut
Dnipropetrovsk, , Ukraine
Oblasna klinichna likarnia, revmatolohichne viddilennia, Derzhavnyi vyshchyi navchalnyi zaklad
Ivano-Frankivsk, , Ukraine
Komunalnyi zaklad okhorony zdorovia "Kharkivska miska klinichna likarnia #8"
Kharkiv, , Ukraine
Khmelnytska oblasna likarnia
Khmelnytskyi, , Ukraine
Kyivska miska klinichna likarnia #6
Kyiv, , Ukraine
Klinichnyi hospital Derzhavnoi prykordonnoi sluzhby Ukrainy
Lviv, , Ukraine
Komunalnyi zaklad "Kryvorizka miska klinichna likarnia #2" Dnipropetrovskoi oblasnoi rady"
M. Kryvyi Rih, , Ukraine
Komunalnyi zaklad Sumskoi oblasnoi rady "Sumska oblasna klinichna likarnia"
M. Sumy, , Ukraine
Vinnytska oblasna klinichna likarnia im. M.I.Pyrohova, revmatolohichne
M. Vinnytsia, , Ukraine
Komunalna ustanova "Odeska oblasna klinichna likarnia"
Odesa, , Ukraine
Bahatoprofilnyi medychnyi tsentr (Universytetska klinika #1)
Odesa, , Ukraine
Komunalna ustanova "Zaporizka oblasna klinichna likarnia" Zaporizkoi oblasnoi rady
Zaporizhzhia, , Ukraine
Wrightington Hospital
Wigan, Lancashire, United Kingdom
Maidstone Hospital, Maidstone and Tunbridge wells NHS Trust
Maidstone, , 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.
Cohen SB, Radominski SC, Kameda H, Kivitz AJ, Tee M, Cronenberger C, Zhang M, Hackley S, Rehman MI, von Richter O, Alten R. Long-term Efficacy, Safety, and Immunogenicity of the Infliximab (IFX) Biosimilar, PF-06438179/GP1111, in Patients with Rheumatoid Arthritis After Switching from Reference IFX or Continuing Biosimilar Therapy: Week 54-78 Data From a Randomized, Double-Blind, Phase III Trial. BioDrugs. 2020 Apr;34(2):197-207. doi: 10.1007/s40259-019-00403-z.
Palaparthy R, Rehman MI, von Richter O, Yin D. Population pharmacokinetics of PF-06438179/GP1111 (an infliximab biosimilar) and reference infliximab in patients with moderately to severely active rheumatoid arthritis. Expert Opin Biol Ther. 2019 Oct;19(10):1065-1074. doi: 10.1080/14712598.2019.1635583. Epub 2019 Jul 8.
Alten R, Batko B, Hala T, Kameda H, Radominski SC, Tseluyko V, Babic G, Cronenberger C, Hackley S, Rehman M, von Richter O, Zhang M, Cohen S. Randomised, double-blind, phase III study comparing the infliximab biosimilar, PF-06438179/GP1111, with reference infliximab: efficacy, safety and immunogenicity from week 30 to week 54. RMD Open. 2019 Mar 28;5(1):e000876. doi: 10.1136/rmdopen-2018-000876. eCollection 2019.
Cohen SB, Alten R, Kameda H, Hala T, Radominski SC, Rehman MI, Palaparthy R, Schumacher K, Schmitt S, Hua SY, Ianos C, Sewell KL. A randomized controlled trial comparing PF-06438179/GP1111 (an infliximab biosimilar) and infliximab reference product for treatment of moderate to severe active rheumatoid arthritis despite methotrexate therapy. Arthritis Res Ther. 2018 Jul 27;20(1):155. doi: 10.1186/s13075-018-1646-4.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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REFLECTIONS B537-02
Identifier Type: OTHER
Identifier Source: secondary_id
2013-004148-49
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
B5371002
Identifier Type: -
Identifier Source: org_study_id
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