A Study of PF-06438179 (Infliximab-Pfizer) and Infliximab in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis (REFLECTIONS B537-02).

A Phase 3 Randomized, Double-blind Study Assessing The Efficacy And Safety Of Pf-06438179 And Infliximab In Combination With Methotrexate In Subjects With Moderately To Severely Active Rheumatoid Arthritis Who Have Had An Inadequate Response To Methotrexate

The study will assess the efficacy and safety of PF-06438179 and infliximab in combination with methotrexate in subjects with active rheumatoid arthritis who have had an inadequate response to methotrexate.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Biological: PF-06438179; Biological: Infliximab

• Study Type: Interventional
• Enrollment (Actual): 650
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Southport, Queensland, Australia, 4215
      • Gold Coast Private Hospital Pty Ltd
    • Southport, Queensland, Australia, 4215
      • HPS Pharmacies
    • Southport, Queensland, Australia, 4215
      • Paradise Arthritis and Rheumatology Pty Ltd
  • South Australia
    • Woodville South, South Australia, Australia, 5011
      • The Queen Elizabeth Hospital
  • Western Australia
    • Osborne Park, Western Australia, Australia, 6017
      • CliniPath Pathology
    • Victoria Park, Western Australia, Australia, 6100
      • R.K. Will Pty Ltd
• Bosnia and Herzegovina
  • Banja Luka, Bosnia and Herzegovina, 78000
    • University Hospital Clinical Center Banja Luka
  • Kanton Sarajevo
    • Sarajevo, Kanton Sarajevo, Bosnia and Herzegovina, 71000
      • Clinical Center University of Sarajevo
    • Sarajevo, Kanton Sarajevo, Bosnia and Herzegovina, 71000
      • General Hospital "Prim.dr.Abdulah Nakas"
  • Tuzlanski Kanton
    • Tuzla, Tuzlanski Kanton, Bosnia and Herzegovina, 75000
      • University Clinical Center Tuzla
• Brazil
  • São Paulo, Brazil, 05652-900
    • Hospital Israelita Albert Einstein
  • Paraná
    • Curitiba, Paraná, Brazil, 80030-110
      • Ceti - Centro de Estudos Em Terapias Inovadoras
• Bulgaria
  • Plovdiv, Bulgaria, 4000
    • Multiprofile Hospital for Active Treatment Trimontium OOD
  • Plovdiv, Bulgaria, 4002
    • University Multiprofile Hospital for Active Treatment (UMHAT) "Kaspela" EOOD
  • Sofia, Bulgaria, 1612
    • University Multiprofile Hospital for Active Treatment (UMHAT) "Sv. Ivan Rilski" EAD
• Canada
  • Ontario
    • Windsor, Ontario, Canada, N8X 2C9
      • Clinical Research and Arthritis Center
• Czechia
  • Brno, Czechia, 602 00
    • CCBR Czech Brno, s.r.o.
  • Brno, Czechia, 602 00
    • Lekarna Lancier, s.r.o.
  • Pardubice, Czechia, 530 02
    • BENU Lekarna
  • Pardubice, Czechia, 530 02
    • CCBR-SYNARC a.s.
  • Praha, Czechia, 130 00
    • Lekarna U Robina, s.r.o.
  • Praha 3, Czechia, 130 00
    • CCBR Czech Prague, s.r.o.
  • Uherske Hradiste, Czechia, 686 01
    • Medical Plus, S.R.O.
  • Uherske Hradiste, Czechia, 686 01
    • Lekarna Hradebni s.r.o.
• Georgia
  • Tbilisi, Georgia, 0160
    • LTD MediClubGeorgia
  • Tbilisi, Georgia, 0159
    • Tbilisi Heart and Vascular Clinic Ltd
  • Tbilisi, Georgia, 0159
    • LTD Tbilisi Central Hospital
  • Tbilisi, Georgia, 0159
    • LTD Unimedi Kakheti
  • Tbilisi, Georgia, 0186
    • LTD Adapti
  • Tbilisi, Georgia, 0186
    • LTD Medulla" Chemotherapy and Immunotherapy Clinic
• Germany
  • Berlin, Germany, 14059
    • Schlosspark-Klinik
  • München, Germany, 80336
    • Klinikum der Universität München
  • Olsberg, Germany, 59939
    • Elisabeth-Klinik gGmbH
  • Puettlingen, Germany, 66346
    • Knappschaftsklinikum Saar GmbH
  • Ratingen, Germany, 40878
    • Rheumazentrum Ratingen
• Guatemala
  • Guatemala, Guatemala, 01010
    • Clínica Médica Especializada en Medicina Interna y Reumatología
  • Guatemala, Guatemala, 01011
    • Clínica Médica Especializada en Medicina Interna
  • Guatemala, Guatemala, 01015
    • Centro de Nutricion y Rehabilitacion Cardiorespiratoria, S.A. (NUCARE)
  • Guatemala, Guatemala, 01015
    • Therapeutic Research Institute and Lab S.A
• Hungary
  • Balatonfüred, Hungary, 8230
    • DRC Gyogyszervizsgalo Kozpont Kft.
  • Budapest, Hungary, 1036
    • Qualiclinic Kft.
• Israel
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus
  • Jerusalem, Israel, 91120
    • Hadassah Medical Organization, Hadassah Medical Center, Ein-Karem
  • Kfar Saba, Israel, 4428164
    • Meir Medical Center
• Japan
  • Chiba, Japan, 260-8712
    • National Hospital Organization Chiba-East Hospital
  • Fukuoka, Japan, 810-8563
    • National Hospital Organization Kyushu Medical Center
  • Fukuoka, Japan, 810-0001
    • Kondo clinic for rheumatism and orthopaedics
  • Kumamoto, Japan, 862-0976
    • Kumamoto Orthopaedic Hospital
  • Aichi
    • Anjo-shi, Aichi, Japan, 446-8602
      • Anjo Kosei Hospital
  • Fukuoka
    • Iiduka, Fukuoka, Japan, 820-8505
      • Aso Iizuka Hospital
  • Gunma
    • Takasaki, Gunma, Japan, 370-0053
      • Inoue Hospital
  • Hiroshima
    • Aki-gun, Hiroshima, Japan, 735-8585
      • Mazda Hospital
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 060-8648
      • Hokkaido University Hospital
    • Sapporo, Hokkaido, Japan, 060-8604
      • Sapporo City General Hospital
  • Hyogo
    • Katoh, Hyogo, Japan, 673-1462
      • Matsubara Mayflower Hospital
  • Kanagawa
    • Sagamihara, Kanagawa, Japan, 252-0392
      • National Hospital Organization Sagamihara National Hospital
    • Yokohama, Kanagawa, Japan, 236-0037
      • Yokohama Minami Kyosai Hospital
  • Nagasaki
    • Omura, Nagasaki, Japan, 856-8562
      • National Hospital Organization Nagasaki Medical Center
    • Sasebo, Nagasaki, Japan, 857-1195
      • Sasebo Chuo Hospital
  • Okayama
    • Kurashiki, Okayama, Japan, 710-0016
      • Kurashiki Sweet Hospital
  • Okinawa
    • Tomigusuku, Okinawa, Japan, 901-0243
      • Yuaikai Tomishiro Central Hospital
  • Saitama
    • Kawagoe-shi, Saitama, Japan, 350-8550
      • Saitama Medical Center
    • Tokorozawa-shi, Saitama, Japan, 359-1111
      • Hirose Clinic
  • Shizuoka
    • Sunto-gun, Shizuoka, Japan, 411-8611
      • National Hospital Organization Shizuoka Medical Center
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 104-8560
      • St. Luke's International Hospital
    • Meguro-ku, Tokyo, Japan, 153-8515
      • Toho University Ohashi Medical Center
    • Shinagawa-ku, Tokyo, Japan, 142-8666
      • Showa University Hospital
• Jordan
  • Amman, Jordan, 11152
    • Jordan Hospital
  • Irbid, Jordan, 22110
    • King Abdullah University Hospital
• Korea, Republic of
  • Daejeon, Korea, Republic of, 35015
    • Chungnam National University Hospital
  • Gwangju, Korea, Republic of, 61469
    • Chonnam National University Hospital
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 143-729
    • Konkuk University Medical Center
  • Seoul, Korea, Republic of, 04763
    • Hanyang University Seoul Hospital
  • Seoul, Korea, Republic of, 120-752
    • Severance Hospital, Yonsei University Health System
• Lithuania
  • Kaunas, Lithuania, LT-50009
    • LSMUL Kauno klinikos
• Mexico
  • SAN LUIS DE Potosi
    • San Luis De Potosí, SAN LUIS DE Potosi, Mexico, 78213
      • Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi, S.C.
    • Zona Universitaria, SAN LUIS DE Potosi, Mexico, CP 78240
      • Unidad de Investigaciones Reumatológicas A.C - Hospital Central "Dr. Ignacio Morones Prieto"
  • Yucatan
    • Merida, Yucatan, Mexico, CP 97000
      • Unidad Reumatologica Las Americas S.C.P
• Morocco
  • Salé, Morocco, 11150
    • El Ayachi Hospital
  • Salé, Morocco, 11150
    • Groupe Radiologique de Salé
  • Salé, Morocco, 11150
    • Laboratoire les Arcades d'Analyses Médicales
• Peru
  • Arequipa, Peru, CP656
    • Centro de diagnóstico por imágenes, Radiología General y Especial
  • Arequipa, Peru, CP656
    • Unidad de Investigación en Medicina Interna y Enfermedades Críticas
  • Lima, Peru, Lima 27
    • Centro de Investigación Reumatología CAA
  • Lima, Peru, Lima 31
    • Clinica Medica Cayetano Heredia
  • Lima, Peru, Lima 31
    • Servicio de Inmunología y Reumatología
  • Lima
    • San juan de Miraflores, Lima, Peru, Lima 29
      • Hospital Maria Auxiliadora - Centro de Investigaciones Medicas
    • Santiago de Surco, Lima, Peru, Lima 33
      • Instituto de Ginecología y Reproducción & Cirugía Mínimamente Invasiva
• Philippines
  • Manila, Philippines, 1000
    • Philippine General Hospital
  • Manila, Philippines, 1000
    • Medical Center Manila
  • Quezon, Philippines, 1102
    • St. Luke's Medical Center
  • Batangas
    • Lipa City, Batangas, Philippines, 4217/043
      • Mary Mediatrix Medical Center
  • Davao DEL SUR
    • Davao, Davao DEL SUR, Philippines, 8000
      • Southern Philippines Medical Center
  • Metro Manila
    • Makati, Metro Manila, Philippines, 1229
      • Makati Medical Center
• Poland
  • Bydgoszcz, Poland, 85-168
    • Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w Bydgoszczy
  • Krakow, Poland, 31-121
    • Szpital Specjalistyczny im. J. Dietla Malopolskie Centrum Reumatologii Immunologii i Rehabilitacji
  • Nadarzyn, Poland, 05-830
    • NZOZ Lecznica MAK-MED. S.C.
  • Nowa Sol, Poland, 67-100
    • Twoja Przychodnia - Centrum Medyczne Nowa Sol
  • Warszawa, Poland, 02-106
    • MTZ Clinical Research Sp. z o.o.
• Romania
  • Galati, Romania, 800578
    • Spitalul Clinic Judetean de Urgenta Galati "Sf. Apostol Andrei"
  • Iasi, Romania, 700656
    • Spitalul Clinic de Recuperare Iasi
  • Targu Mures, Romania, 540136
    • Spitalul Clinic Judetean de Urgenta Targu Mures
• Russian Federation
  • Kemerovo, Russian Federation, 650000
    • GAUZ of Kemerovo Region "Regional clinical hospital for war veterans"
  • Krasnoyarsk, Russian Federation, 660014
    • KGBUZ "Krasnoyarsk Interdistrict Clinical Hospital #20 n.a. I.S.Berzon"
  • Krasnoyarsk, Russian Federation, 660022
    • Krasnoyarsk State Medical University n.a.Prof.V.F.Voyno-Yasenetsky
  • Kursk, Russian Federation, 305007
    • GMU " Kursk regional clinical hospital" of the Committee of Healthcare of the Kursk region
  • Moscow, Russian Federation, 129327
    • GBUZ of city of Moscow
  • Ryazan, Russian Federation, 390026
    • GBOU VPO "Ryazan State medical university n.a. academician I.P.Pavlov"
  • Ryazan, Russian Federation, 390026
    • GBOUVPO "Ryazan State Medical University n.a. Academician I.P.Pavlov"
  • Ryazan, Russian Federation, 390026
    • GBU of Ryazan region "Regional clinical cardiology dispanser"
  • Ryazan, Russian Federation, 390039
    • GBOU of Ryazan region "Regional clinical hospital"
  • Saint-Petersburg, Russian Federation, 190068
    • Spb GBUZ "Clinical rheumatology hospital # 25" City CDC prevention of osteoporosis
  • Saratov, Russian Federation, 410053
    • GUZ "Regional Clinical Hospital"
  • Vladimir, Russian Federation, 600023
    • GBUZ VO 'Regional clinical hospital"
  • Yaroslavl, Russian Federation, 150002
    • GBKUZ of Yaroslavl region "City hospital n. a. N.A. Semashko"
  • Republic OF Karelia
    • Petrozavodsk, Republic OF Karelia, Russian Federation, 185019
      • GBUZ "Republican hospital n.a. V.A.Baranov"
• Serbia
  • Belgrade, Serbia, 11 000
    • Clinical hospital center Bezanijska Kosa
  • Belgrade, Serbia, 11 000
    • Military Medical Academy
  • Niska Banja, Serbia, 18205
    • Institute for treatment and rehabilitation "Niska Banja"
• South Africa
  • Gauteng
    • Johannesburg, Gauteng, South Africa, 2193
      • Charlotte Maxeke Johannesburg Academic Hospital
    • Pretoria, Gauteng, South Africa, 0084
      • Emmed Research
    • Pretoria, Gauteng, South Africa, 0002
      • Jakaranda Hospital
  • Western CAPE
    • Cape Town, Western CAPE, South Africa, 7405
      • Arthritis Clinical Research Unit
    • Cape Town, Western CAPE, South Africa, 7405
      • Vincent Pallotti Hospital
• Tunisia
  • Manouba, Tunisia, 2010
    • Mohamed Kassab Institute of orthopedics
  • Tunis, Tunisia, 1007
    • Rabta Hospital
• Ukraine
  • Dnipropetrovsk, Ukraine, 49027
    • Derzhavna ustanova "Ukrainskyi derzhavnyi naukovo-doslidnyi instytut
  • Ivano-Frankivsk, Ukraine, 76008
    • Oblasna klinichna likarnia, revmatolohichne viddilennia, Derzhavnyi vyshchyi navchalnyi zaklad
  • Kharkiv, Ukraine, 61176
    • Komunalnyi zaklad okhorony zdorovia "Kharkivska miska klinichna likarnia #8"
  • Khmelnytskyi, Ukraine, 29000
    • Khmelnytska oblasna likarnia
  • Kyiv, Ukraine, 03680
    • Kyivska miska klinichna likarnia #6
  • Lviv, Ukraine, 79014
    • Klinichnyi hospital Derzhavnoi prykordonnoi sluzhby Ukrainy
  • M. Kryvyi Rih, Ukraine, 50056
    • Komunalnyi zaklad "Kryvorizka miska klinichna likarnia #2" Dnipropetrovskoi oblasnoi rady"
  • M. Sumy, Ukraine, 40022
    • Komunalnyi zaklad Sumskoi oblasnoi rady "Sumska oblasna klinichna likarnia"
  • M. Vinnytsia, Ukraine, 21018
    • Vinnytska oblasna klinichna likarnia im. M.I.Pyrohova, revmatolohichne
  • Odesa, Ukraine, 65025
    • Komunalna ustanova "Odeska oblasna klinichna likarnia"
  • Odesa, Ukraine, 65026
    • Bahatoprofilnyi medychnyi tsentr (Universytetska klinika #1)
  • Zaporizhzhia, Ukraine, 69600
    • Komunalna ustanova "Zaporizka oblasna klinichna likarnia" Zaporizkoi oblasnoi rady
• United Kingdom
  • Maidstone, United Kingdom, ME16 9QQ
    • Maidstone Hospital, Maidstone and Tunbridge wells NHS Trust
  • Lancashire
    • Wigan, Lancashire, United Kingdom, WN6 9EP
      • Wrightington Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35216
      • Achieve Clinical Research, LLC
    • Tuscaloosa, Alabama, United States, 35406
      • Clinical and Translational Research Center of Alabama, PC
  • Arizona
    • Peoria, Arizona, United States, 85381
      • Sun Valley Arthritis Center, Ltd.
    • Phoenix, Arizona, United States, 85037
      • Arizona Arthritis & Rheumatology Associates, P.C.
  • California
    • Fullerton, California, United States, 92835
      • St. Jude Hospital Yorba Linda dba St. Joseph Heritage Healthcare
    • La Palma, California, United States, 90623
      • Arthritis & Osteoporosis Medical Center
    • Upland, California, United States, 91786
      • Inland Rheumatology Clinical Trials, Inc.
    • Victorville, California, United States, 92395
      • Desert Valley Medical Group
  • Delaware
    • Newark, Delaware, United States, 19713
      • Javed Rheumatology Associates, Inc
  • Florida
    • Aventura, Florida, United States, 33180
      • Arthritis and Rheumatic Disease Specialties
    • Daytona Beach, Florida, United States, 32117
    • Daytona Beach, Florida, United States, 32117
      • International Medical Research
    • Miami, Florida, United States, 33015
      • San Marcus Research Clinic, Inc.
    • Miami, Florida, United States, 33165
      • Advance Medical Research Services Corporation
    • Sarasota, Florida, United States, 34239
      • Sarasota Arthritis Research Center
    • Vero Beach, Florida, United States, 32960
      • Alastair C. Kennedy, MD
    • Vero Beach, Florida, United States, 32960
      • Indian River Primary Care
  • Georgia
    • Rome, Georgia, United States, 30165
      • Harbin Clinic
  • Idaho
    • Meridian, Idaho, United States, 83642
      • Advanced Clinical Research
  • Illinois
    • Peoria, Illinois, United States, 61636
      • Methodist Medical Center of IL
  • Iowa
    • Cedar Rapids, Iowa, United States, 52403
      • Physician's Clinic of Iowa, P.C.
  • Kentucky
    • Bowling Green, Kentucky, United States, 42101
      • Gilbert-Graves Clinic
    • Bowling Green, Kentucky, United States, 42101
      • Graves-Gilbert Clinic Bowling Green
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Ochsner Clinic Baton Rouge
    • Monroe, Louisiana, United States, 71203
      • Arthritis and Diabetes Clinic, Inc.
  • Maryland
    • Wheaton, Maryland, United States, 20902
      • The Center for Rheumatology and Bone Research
  • Michigan
    • Battle Creek, Michigan, United States, 49015
      • Western Michigan University Homer Stryker MD School of Medicine Center for Clinical Research
  • New Jersey
    • Voorhees, New Jersey, United States, 08043
      • Arthritis, Rheumatic & Back Disease Associates
  • North Dakota
    • Minot, North Dakota, United States, 58701
      • Trinity Health Center-Medical Arts
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Altoona Center for Clinical Research
    • Wyomissing, Pennsylvania, United States, 19610
      • Clinical Research Center of Reading, LLC
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • Low Country Rheumatology, PA
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Regional Health Clinical Research
    • Rapid City, South Dakota, United States, 57701
      • Regional Medical Clinic
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • West Tennessee Research Institute
    • Memphis, Tennessee, United States, 38119
      • Ramesh C Gupta, MD
  • Texas
    • Austin, Texas, United States, 78731
      • Austin Regional Clinic
    • Dallas, Texas, United States, 75231
      • Metroplex Clinical Research Center
    • Houston, Texas, United States, 77034
      • Accurate Clinical Research, Inc.
    • Nassau Bay, Texas, United States, 77058
      • Accurate Clinical Research
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Pharmacy Services, Sentara Leigh Hospital
    • Norfolk, Virginia, United States, 23502
      • Sentara Medical Group, Clinical Research
  • Washington
    • Seattle, Washington, United States, 98133
      • The Seattle Arthritis Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Diagnosis of rheumatoid arthritis based on 2010 ACR/EULAR criteria for at least 4 months.

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 of untreated or inadequately treated latent or active TB.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Infliximab	Biological: 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 Names: Infliximab-EU, Remicade
Experimental: PF-06438179	Biological: 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.; Other Names: Infliximab-Pfizer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 14: Period 1	ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count (TJC); >= 20% improvement in swollen joint count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity (PGA); physician global assessment of disease activity; self-assessed disability (health assessment questionnaire-disability index [HAQ-DI]); and C-Reactive Protein (CRP).	Week 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 2, 4, 6, 12, 22 and 30 (Pre-dose): Period 1	ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; HAQ-DI and CRP.	Week 2, 4, 6, 12, 22 and 30 (pre-dose)
Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 38, 46 and 54 (Pre-dose): Period 2	ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; HAQ-DI and CRP.	Week 38, 46 and 54 (pre-dose)
Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 62, 70 and 78: Period 3	ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; HAQ-DI and CRP.	Week 62, 70 and 78
Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 2, 4, 6, 12, 14, 22 and 30 (Pre-dose): Period 1	ACR50 response: >=50% improvement in tender joint count, >=50% improvement in swollen joint count improvement and >=50% in at least 3 of 5 remaining ACR core measures: participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP. ACR70 response: >=70% improvement in tender joint count, >=70% improvement in swollen joint count improvement and >=70% in at least 3 of 5 remaining ACR core measures: participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP.	Week 2, 4, 6, 12, 14, 22 and 30 (pre-dose)
Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 38, 46 and 54 (Pre-dose): Period 2	ACR50 response: >=50% improvement in tender joint count, >=50% improvement in swollen joint count improvement and >=50% in at least 3 of 5 remaining ACR core measures: participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP. ACR70 response: >=70% improvement in tender joint count, >=70% improvement in swollen joint count improvement and >=70% in at least 3 of 5 remaining ACR core measures: participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP.	Week 38, 46 and 54 (pre-dose)
Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 62, 70 and 78: Period 3	ACR50 response: >=50% improvement in tender joint count, >=50% improvement in swollen joint count improvement and >=50% in at least 3 of 5 remaining ACR core measures: participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP. ACR70 response: >=70% improvement in tender joint count, >=70% improvement in swollen joint count improvement and >=70% in at least 3 of 5 remaining ACR core measures: participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, HAQ-DI and CRP.	Week 62, 70 and 78
Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 2, 4, 6, 12, 14, 22 and 30: Period 1	DAS28 is measure of disease activity in participants. DAS28-4 (CRP): calculated from SJC, TJC, CRP(mg/L) and PGA (participant rated disease activity on visual analogue scale [VAS] from 0 to 100 mm; high score=worse health). Total score range of DAS28-4 (CRP): 0 to 9.4(0=no activity; 9.4=extreme disease activity), higher score=more disease activity. DAS28-4(CRP) less than (<)2.6=remission, <3.2=low disease activity, >=3.2-5.1=moderate disease activity and greater than (>) 5.1=high disease activity. HAQ-DI assess degree of difficulty a participant experienced (past week) in 8 domain of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each item scored on a 4-point scale ranging from 0 to 3(0=no difficulty; 3=extreme difficulty). Overall score: sum of domain scores/number of domains answered. Total possible score range (0=least difficulty; 3=extreme difficulty); high scores=more difficulty in performing daily living activities.	Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and 30
Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 38, 46 and 54: Period 2	DAS28 is measure of disease activity in participants. DAS28-4 (CRP): calculated from SJC, TJC, CRP(mg/L) and PGA (participant rated disease activity on VAS from 0 to 100 millimeter [mm]; high score=worse health). Total score range of DAS28-4 (CRP): 0 to 9.4(0=no activity; 9.4=extreme disease activity), higher score=more disease activity. DAS28-4(CRP) <2.6=remission, <3.2=low disease activity, >=3.2-5.1=moderate disease activity and >5.1=high disease activity. HAQ-DI assess degree of difficulty a participant experienced (past week) in 8 domain of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each item scored on a 4-point scale ranging from 0 to 3(0=no difficulty; 3=extreme difficulty). Overall score: sum of domain scores/number of domains answered. Total possible score range (0=least difficulty; 3=extreme difficulty); high scores=more difficulty in performing daily living activities.	Baseline (Week 30 pre-dose), Week 38, 46 and 54
Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 62, 70 and 78: Period 3	DAS28 is measure of disease activity in participants. DAS28-4 (CRP): calculated from SJC, TJC, CRP(mg/L) and PGA (participant rated disease activity on VAS from 0 to 100 mm; high score=worse health). Total score range of DAS28-4 (CRP): 0 to 9.4(0=no activity; 9.4=extreme disease activity), higher score=more disease activity. DAS28-4(CRP) <2.6=remission, <3.2=low disease activity, >=3.2-5.1=moderate disease activity and >5.1=high disease activity. HAQ-DI assess degree of difficulty a participant experienced (past week) in 8 domain of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each item scored on a 4-point scale ranging from 0 to 3(0=no difficulty; 3=extreme difficulty). Overall score: sum of domain scores/number of domains answered. Total possible score range (0=least difficulty; 3=extreme difficulty); high scores=more difficulty in performing daily living activities.	Baseline (Week 54 pre-dose), Week 62, 70 and 78
Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1	ACR/EULAR remission was considered if the scores on tender joint count, swollen joint count, hs-CRP (mg/dL), and patient's global assessment of arthritis (PGA) all were less than or equal to (=<) 1 or the score on the simplified disease activity index (SDAI) was =<3.3. SDAI was calculated as the sum of number of tender and swollen joint count (using 28 joints), PGA, physician global assessment, and CRP (mg/dL). PGA was assessed on a 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores indicate worse health condition. Physician global assessment was recorded on a 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores indicated more disease activity. DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, CRP (mg/dL) and PGA using a 10 mm-VAS from 0 (very well) to 10 (very poor), where higher scores indicate worse health condition. DAS28 <3.2: low disease activity, DAS28 <2.6: remission.	Week 2, 4, 6, 12, 14, 22 and Week 30 (pre-dose)
Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 2	ACR/EULAR remission was considered if the scores on tender joint count, swollen joint count, hs-CRP (mg/dL), and PGA all were =<1 or the score on the SDAI was =<3.3. SDAI was calculated as the sum of number of tender and swollen joint count (using 28 joints), PGA, physician global assessment, and CRP (mg/dL). PGA was assessed on a 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores indicate worse health condition. Physician global assessment was recorded on a 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores indicated more disease activity. DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, CRP (mg/dL) and PGA using a 10 mm-VAS from 0 (very well) to 10 (very poor), where higher scores indicate worse health condition. DAS28 <3.2: low disease activity, DAS28 <2.6: remission.	Week 38, 46 and 54 (pre-dose)
Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 3	ACR/EULAR remission was considered if the scores on tender joint count, swollen joint count, hs-CRP (mg/dL), and PGA all were =<1 or the score on the SDAI was =<3.3. SDAI was calculated as the sum of number of tender and swollen joint count (using 28 joints), PGA, physician global assessment, and CRP (mg/dL). PGA was assessed on a 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores indicate worse health condition. Physician global assessment was recorded on a 10 mm VAS ranging from 0 (very well) to 10 (very poor), where higher scores indicated more disease activity. DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, CRP (mg/dL) and PGA using a 10 mm-VAS from 0 (very well) to 10 (very poor), where higher scores indicate worse health condition. DAS28 <3.2: low disease activity, DAS28 <2.6: remission.	Week 62, 70 and 78
Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1	EULAR response was based on DAS28 EULAR response criteria which was defined as good response = DAS28 change of >1.2 with DAS28 =<3.2; moderate response = DAS28 change of >0.6 to =<1.2 with DAS28 >3.2-5.1 and no-response = DAS28 change of =<0.6 with DAS28 >5.1.	Week 2, 4, 6, 12, 14, 22 and Week 30 (pre-dose)
Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2	EULAR response was based on DAS28 EULAR response criteria which was defined as good response = DAS28 change of >1.2 with DAS28 =<3.2; moderate response = DAS28 change of >0.6 to =<1.2 with DAS28 >3.2-5.1 and no-response = DAS28 change of =<0.6 with DAS28 >5.1.	Week 38, 46 and Week 54 (pre-dose)
Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3	EULAR response was based on DAS28 EULAR response criteria which was defined as good response = DAS28 change of >1.2 with DAS28 =<3.2; moderate response = DAS28 change of >0.6 to =<1.2 with DAS28 >3.2-5.1 and no-response = DAS28 change of =<0.6 with DAS28 >5.1.	Week 62, 70 and Week 78
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 1	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Week 30 that were absent before treatment or that worsened relative to pre-treatment state. Treatment-related TEAE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs included both serious and non-serious adverse events.	Baseline (Day 1) up to Week 30
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 2	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Week 54 that were absent before treatment or that worsened relative to pre-treatment state. Treatment-related TEAE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs included both serious and non-serious adverse events.	Baseline (Week 30 pre-dose) up to Week 54
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 3	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Week 78 that were absent before treatment or that worsened relative to pre-treatment state. Treatment-related TEAE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs included both serious and non-serious adverse events.	Baseline (Week 54 pre-dose) up to Week 78
Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 1	AEs were graded in accordance with National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) Version 4.03 as Grades 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life threatening AEs and Grade 5= death related to AE. AEs of Grade 3 and higher severity are reported in this outcome measure.	Baseline (Day 1) up to Week 30
Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 2	AEs were graded in accordance with National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) Version 4.03 as Grades 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life threatening AEs and Grade 5= death related to AE. AEs of Grade 3 and higher severity are reported in this outcome measure.	Baseline (Week 30 pre-dose) up to Week 54
Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 3	AEs were graded in accordance with National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) Version 4.03 as Grades 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life threatening AEs and Grade 5= death related to AE. AEs of Grade 3 and higher severity are reported in this outcome measure.	Baseline (Week 54 pre-dose) up to Week 78
Number of Participants With Laboratory Abnormalities: Period 1	Criteria for abnormality:hematology: hemoglobin, hematocrit, red blood cell count, lymphocytes, neutrophils: <0.8*lower limit of normal (LLN); platelets: >1.75*upper limit of normal (ULN); white blood cell count: <0.6*LLN; basophils, eosinophils, monocytes: >1.2*ULN. liver function: bilirubin: >1.5*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: >3.0*ULN; protein, albumin: <0.8*LLN></0>1.2*ULN; renal function:blood urea nitrogen,creatinine: >1.3*ULN; uric acid: >1.2*ULN; electrolytes: sodium, potassium, chloride, calcium, bicarbonate: <0.9*LLN,>1.1*ULN; urinalysis: pH<4.5, >8; glucose, protein, blood, ketones, urobilinogen, bilirubin, nitrite; Other(glucose: <0.6*LLN,>1.5*ULN). Participants with any laboratory abnormality in Period 1 were reported in this outcome measure.	Baseline (Day 1) up to Week 30
Number of Participants With Laboratory Abnormalities: Period 2	Criteria for abnormality:hematology: hemoglobin, hematocrit, red blood cell count, lymphocytes, neutrophils: <0.8*lower limit of normal (LLN); platelets: >1.75*upper limit of normal (ULN); white blood cell count: <0.6*LLN; basophils, eosinophils, monocytes: >1.2*ULN. liver function: bilirubin: >1.5*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: >3.0*ULN; protein, albumin: <0.8*LLN></0>1.2*ULN; renal function:blood urea nitrogen,creatinine: >1.3*ULN; uric acid: >1.2*ULN; electrolytes: sodium, potassium, chloride, calcium, bicarbonate: <0.9*LLN,>1.1*ULN; urinalysis: pH<4.5, >8; glucose, protein, blood, ketones, urobilinogen, bilirubin, nitrite; Other(glucose: <0.6*LLN,>1.5*ULN). Participants with any laboratory abnormality in Period 2 were reported in this outcome measure.	Baseline (Week 30 pre-dose) up to Week 54
Number of Participants With Laboratory Abnormalities: Period 3	Criteria for abnormality:hematology: hemoglobin, hematocrit, red blood cell count, lymphocytes, neutrophils: <0.8*lower limit of normal (LLN); platelets: >1.75*upper limit of normal (ULN); white blood cell count: <0.6*LLN; basophils, eosinophils, monocytes: >1.2*ULN. liver function: bilirubin: >1.5*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: >3.0*ULN; protein, albumin: <0.8*LLN></0>1.2*ULN; renal function:blood urea nitrogen,creatinine: >1.3*ULN; uric acid: >1.2*ULN; electrolytes: sodium, potassium, chloride, calcium, bicarbonate: <0.9*LLN,>1.1*ULN; urinalysis: pH<4.5, >8; glucose, protein, blood, ketones, urobilinogen, bilirubin, nitrite; Other(glucose: <0.6*LLN,>1.5*ULN). Participants with any laboratory abnormality in Period 3 were reported in this outcome measure.	Baseline (Week 54 pre-dose) up to Week 78
Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1	Tender joint count was an assessment of 68 joints (upper body, upper extremity, and lower extremity). Each joint's response to pressure/motion was assessed as: Present or Absent. Swollen joint count was an assessment of 66 joints (upper body, upper extremity, and lower extremity). Each joint was assessed for swelling as: Present or Absent.	Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and Week 30
Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2	Tender joint count was an assessment of 68 joints (upper body, upper extremity, and lower extremity). Each joint's response to pressure/motion was assessed as: Present or Absent. Swollen joint count was an assessment of 66 joints (upper body, upper extremity, and lower extremity). Each joint was assessed for swelling as: Present or Absent.	Baseline (Week 30 pre-dose), Week 38, 46 and Week 54
Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3	Tender joint count was an assessment of 68 joints (upper body, upper extremity, and lower extremity). Each joint's response to pressure/motion was assessed as: Present or Absent. Swollen joint count was an assessment of 66 joints (upper body, upper extremity, and lower extremity). Each joint was assessed for swelling as: Present or Absent.	Baseline (Week 54 pre-dose), Week 62, 70 and 78
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 2, 4, 6, 12, 14, 22, 30: Period 1	PAAP: Participants assessed the severity of their arthritis pain by using a 100 mm VAS ranging from 0 (no pain) to 100 (most severe pain), which corresponded to the magnitude of their pain, where higher scores indicated more pain. PGA: Participants were asked the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" and their response was recorded on a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated worse health condition. PGAA: Participants were assessed how their overall arthritis appears at the time of the visit. The evaluation was based on the participant's disease signs, functional capacity and physical examination, and was independent of the PAAP and PGA assessments. The physician's response was recorded using a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated more disease activity.	Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and 30
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 38, 46 and 54: Period 2	PAAP: Participants assessed the severity of their arthritis pain by using a 100 mm VAS ranging from 0 (no pain) to 100 (most severe pain), which corresponded to the magnitude of their pain, where higher scores indicated more pain. PGA: Participants were asked the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" and their response was recorded on a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated worse health condition. PGAA: Participants were assessed how their overall arthritis appears at the time of the visit. The evaluation was based on the participant's disease signs, functional capacity and physical examination, and was independent of the PAAP and PGA assessments. The physician's response was recorded using a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated more disease activity.	Baseline (Week 30 pre-dose), Week 38, 46 and 54
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP), Patient's Global Assessment of Arthritis (PGA) and Physician's Global Assessment of Arthritis (PGAA) at Week 62, 70 and 78: Period 3	PAAP: Participants assessed the severity of their arthritis pain by using a 100 mm VAS ranging from 0 (no pain) to 100 (most severe pain), which corresponded to the magnitude of their pain, where higher scores indicated more pain. PGA: Participants were asked the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" and their response was recorded on a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated worse health condition. PGAA: Participants were assessed how their overall arthritis appears at the time of the visit. The evaluation was based on the participant's disease signs, functional capacity and physical examination, and was independent of the PAAP and PGA assessments. The physician's response was recorded using a 100 mm VAS ranging from 0 (very well) to 100 (very poor), where higher scores indicated more disease activity.	Baseline (Week 54 pre-dose), Week 62, 70 and 78
Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 2, 4, 6, 12, 14, 22 and 30: Period 1		Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and 30
Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 38, 46 and 54: Period 2		Baseline (Week 30 pre-dose), Week 38, 46 and 54
Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 62, 70 and 78: Period 3		Baseline (Week 54 pre-dose), Week 62, 70 and 78
Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 1	ADA positive results was defined as ADA titer level >=1.30 and NAb positive was defined as NAb titer level >=0.70.	Baseline (Day 1) up to Week 30
Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 2	ADA positive results was defined as ADA titer level >=1.30 and NAb positive was defined as NAb titer level >=0.70.	Baseline (Week 30 pre-dose) up to Week 54
Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 3	ADA positive results was defined as ADA titer level >=1.30 and NAb positive was defined as NAb titer level >=0.70.	Baseline (Week 54 pre-dose) up to Week 78
Serum Concentration Versus Time Summary: Period 1		Pre dose on Day 1, 15, 43, 99, 155 and 211; 2 hours post dose on Day 1 and 99; and 336 hours post dose on Day 29
Serum Concentration Versus Time Summary: Period 2		Pre dose on Day 211, 267, 379 and 547
Serum Concentration Versus Time Summary: Period 3		Pre dose on Day 379, 435 and 547

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• 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). pii: 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.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2014
• Primary Completion (Actual): June 29, 2016
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: August 19, 2014
• First Submitted That Met QC Criteria: August 19, 2014
• First Posted (Estimate): August 21, 2014

Study Record Updates

• Last Update Posted (Actual): May 30, 2018
• Last Update Submitted That Met QC Criteria: April 30, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: rheumatoid arthritis; Phase 3; infliximab
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Antirheumatic Agents; Gastrointestinal Agents; Dermatologic Agents; Infliximab
• Other Study ID Numbers: B5371002; REFLECTIONS B537-02 (Other Identifier: Alias ID); 2013-004148-49 (EudraCT Number)