Clinical trial NCT02222493: A Study of PF-06438179 (Infliximab-Pfizer) and Infliximab in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis (REFLECTIONS B537-02).
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: Phase 3
infliximab
rheumatoid arthritis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-08-21
Enrollment: 650
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 14: Period 1
timeFrame: Week 14
Secondary outcomes:
measure: 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
timeFrame: Week 2, 4, 6, 12, 22 and 30 (pre-dose)
measure: Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 38, 46 and 54 (Pre-dose): Period 2
timeFrame: Week 38, 46 and 54 (pre-dose)
measure: Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 62, 70 and 78: Period 3
timeFrame: Week 62, 70 and 78
measure: 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
timeFrame: Week 2, 4, 6, 12, 14, 22 and 30 (pre-dose)
measure: 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
timeFrame: Week 38, 46 and 54 (pre-dose)
measure: Number of Participants With an American College of Rheumatology 50% (ACR50) and ACR 70% Response at Week 62, 70 and 78: Period 3
timeFrame: Week 62, 70 and 78
measure: 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
timeFrame: Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and 30
measure: Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 38, 46 and 54: Period 2
timeFrame: Baseline (Week 30 pre-dose), Week 38, 46 and 54
measure: Change From Baseline in Disease Activity Score-CRP (4 Variables) (DAS28-4 [CRP]) and HAQ-DI at Week 62, 70 and 78: Period 3
timeFrame: Baseline (Week 54 pre-dose), Week 62, 70 and 78
measure: Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 1
timeFrame: Week 2, 4, 6, 12, 14, 22 and Week 30 (pre-dose)
measure: Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 2
timeFrame: Week 38, 46 and 54 (pre-dose)
measure: Number of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) and Disease Activity Score (DAS <2.6) Remission: Period 3
timeFrame: Week 62, 70 and 78
measure: Number of Participants With European League Against Rheumatism (EULAR) Response: Period 1
timeFrame: Week 2, 4, 6, 12, 14, 22 and Week 30 (pre-dose)
measure: Number of Participants With European League Against Rheumatism (EULAR) Response: Period 2
timeFrame: Week 38, 46 and Week 54 (pre-dose)
measure: Number of Participants With European League Against Rheumatism (EULAR) Response: Period 3
timeFrame: Week 62, 70 and Week 78
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 1
timeFrame: Baseline (Day 1) up to Week 30
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 2
timeFrame: Baseline (Week 30 pre-dose) up to Week 54
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 3
timeFrame: Baseline (Week 54 pre-dose) up to Week 78
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 1
timeFrame: Baseline (Day 1) up to Week 30
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 2
timeFrame: Baseline (Week 30 pre-dose) up to Week 54
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Grade 3 or Higher Severity: Period 3
timeFrame: Baseline (Week 54 pre-dose) up to Week 78
measure: Number of Participants With Laboratory Abnormalities: Period 1
timeFrame: Baseline (Day 1) up to Week 30
measure: Number of Participants With Laboratory Abnormalities: Period 2
timeFrame: Baseline (Week 30 pre-dose) up to Week 54
measure: Number of Participants With Laboratory Abnormalities: Period 3
timeFrame: Baseline (Week 54 pre-dose) up to Week 78
measure: Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 2, 4, 6, 12, 14, 22 and 30: Period 1
timeFrame: Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and Week 30
measure: Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 38, 46 and 54: Period 2
timeFrame: Baseline (Week 30 pre-dose), Week 38, 46 and Week 54
measure: Change From Baseline in Tender Joint Count and Swollen Joint Count at Week 62, 70 and 78: Period 3
timeFrame: Baseline (Week 54 pre-dose), Week 62, 70 and 78
measure: 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
timeFrame: Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and 30
measure: 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
timeFrame: Baseline (Week 30 pre-dose), Week 38, 46 and 54
measure: 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
timeFrame: Baseline (Week 54 pre-dose), Week 62, 70 and 78
measure: Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 2, 4, 6, 12, 14, 22 and 30: Period 1
timeFrame: Baseline (Day 1), Week 2, 4, 6, 12, 14, 22 and 30
measure: Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 38, 46 and 54: Period 2
timeFrame: Baseline (Week 30 pre-dose), Week 38, 46 and 54
measure: Change From Baseline in High Sensitivity C-Reactive Protein (Hs-CRP) Concentration at Week 62, 70 and 78: Period 3
timeFrame: Baseline (Week 54 pre-dose), Week 62, 70 and 78
measure: Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 1
timeFrame: Baseline (Day 1) up to Week 30
measure: Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 2
timeFrame: Baseline (Week 30 pre-dose) up to Week 54
measure: Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (Nab) Status: Period 3
timeFrame: Baseline (Week 54 pre-dose) up to Week 78
measure: Serum Concentration Versus Time Summary: Period 1
timeFrame: 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
measure: Serum Concentration Versus Time Summary: Period 2
timeFrame: Pre dose on Day 211, 267, 379 and 547
measure: Serum Concentration Versus Time Summary: Period 3
timeFrame: Pre dose on Day 379, 435 and 547
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Achieve Clinical Research, LLC
state: Alabama
city: Tuscaloosa
country: United States
facility: Clinical and Translational Research Center of Alabama, PC
state: Alabama
city: Peoria
country: United States
facility: Sun Valley Arthritis Center, Ltd.
state: Arizona
city: Phoenix
country: United States
facility: Arizona Arthritis & Rheumatology Associates, P.C.
state: Arizona
city: Fullerton
country: United States
facility: St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare
state: California
city: La Palma
country: United States
facility: Arthritis & Osteoporosis Medical Center
state: California
city: Upland
country: United States
facility: Inland Rheumatology Clinical Trials, Inc.
state: California
city: Victorville
country: United States
facility: Desert Valley Medical Group
state: California
city: Newark
country: United States
facility: Javed Rheumatology Associates, Inc
state: Delaware
city: Aventura
country: United States
facility: Arthritis and Rheumatic Disease Specialties
state: Florida
city: Daytona Beach
country: United States
facility: International Medical Research
state: Florida
city: Daytona Beach
country: United States
state: Florida
city: Miami
country: United States
facility: San Marcus Research Clinic, Inc.
state: Florida
city: Miami
country: United States
facility: Advance Medical Research Services Corporation
state: Florida
city: Sarasota
country: United States
facility: Sarasota Arthritis Research Center
state: Florida
city: Vero Beach
country: United States
facility: Alastair C. Kennedy, MD
state: Florida
city: Vero Beach
country: United States
facility: Indian River Primary Care
state: Florida
city: Rome
country: United States
facility: Harbin Clinic
state: Georgia
city: Meridian
country: United States
facility: Advanced Clinical Research
state: Idaho
city: Peoria
country: United States
facility: Methodist Medical Center of IL
state: Illinois
city: Cedar Rapids
country: United States
facility: Physician's Clinic of Iowa, P.C.
state: Iowa
city: Bowling Green
country: United States
facility: Gilbert-Graves Clinic
state: Kentucky
city: Bowling Green
country: United States
facility: Graves-Gilbert Clinic Bowling Green
state: Kentucky
city: Baton Rouge
country: United States
facility: Ochsner Clinic Baton Rouge
state: Louisiana
city: Monroe
country: United States
facility: Arthritis and Diabetes Clinic, Inc.
state: Louisiana
city: Wheaton
country: United States
facility: The Center for Rheumatology and Bone Research
state: Maryland
city: Battle Creek
country: United States
facility: Western Michigan University Homer Stryker MD School of Medicine Center for Clinical Research
state: Michigan
city: Voorhees
country: United States
facility: Arthritis, Rheumatic & Back Disease Associates
state: New Jersey
city: Minot
country: United States
facility: Trinity Health Center-Medical Arts
state: North Dakota
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Wyomissing
country: United States
facility: Clinical Research Center of Reading, LLC
state: Pennsylvania
city: Charleston
country: United States
facility: Low Country Rheumatology, PA
state: South Carolina
city: Rapid City
country: United States
facility: Regional Health Clinical Research
state: South Dakota
city: Rapid City
country: United States
facility: Regional Medical Clinic
state: South Dakota
city: Jackson
country: United States
facility: West Tennessee Research Institute
state: Tennessee
city: Memphis
country: United States
facility: Ramesh C Gupta, MD
state: Tennessee
city: Austin
country: United States
facility: Austin Regional Clinic
state: Texas
city: Dallas
country: United States
facility: Metroplex Clinical Research Center
state: Texas
city: Houston
country: United States
facility: Accurate Clinical Research, Inc.
state: Texas
city: Nassau Bay
country: United States
facility: Accurate Clinical Research
state: Texas
city: Norfolk
country: United States
facility: Pharmacy Services, Sentara Leigh Hospital
state: Virginia
city: Norfolk
country: United States
facility: Sentara Medical Group, Clinical Research
state: Virginia
city: Seattle
country: United States
facility: The Seattle Arthritis Clinic
state: Washington
city: Southport
country: Australia
facility: Gold Coast Private Hospital Pty Ltd
state: Queensland
city: Southport
country: Australia
facility: HPS Pharmacies
state: Queensland
city: Southport
country: Australia
facility: Paradise Arthritis and Rheumatology Pty Ltd
state: Queensland
city: Woodville South
country: Australia
facility: The Queen Elizabeth Hospital
state: South Australia
city: Osborne Park
country: Australia
facility: CliniPath Pathology
state: Western Australia
city: Victoria Park
country: Australia
facility: R.K. Will Pty Ltd
state: Western Australia
city: Sarajevo
country: Bosnia and Herzegovina
facility: Clinical Center University of Sarajevo
state: Kanton Sarajevo
city: Sarajevo
country: Bosnia and Herzegovina
facility: General Hospital "Prim.dr.Abdulah Nakas"
state: Kanton Sarajevo
city: Tuzla
country: Bosnia and Herzegovina
facility: University Clinical Center Tuzla
state: Tuzlanski Kanton
city: Banja Luka
country: Bosnia and Herzegovina
facility: University Hospital Clinical Center Banja Luka
city: Curitiba
country: Brazil
facility: CETI - Centro de Estudos em Terapias Inovadoras
state: Paraná
city: São Paulo
country: Brazil
facility: Hospital Israelita Albert Einstein
city: Plovdiv
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Trimontium OOD
city: Plovdiv
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment (UMHAT) "Kaspela" EOOD
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment (UMHAT) "Sv. Ivan Rilski" EAD
city: Windsor
country: Canada
facility: Clinical Research and Arthritis Center
state: Ontario
city: Brno
country: Czechia
facility: CCBR Czech Brno, s.r.o.
city: Brno
country: Czechia
facility: Lekarna Lancier, s.r.o.
city: Pardubice
country: Czechia
facility: BENU Lekarna
city: Pardubice
country: Czechia
facility: CCBR-SYNARC a.s.
city: Praha 3
country: Czechia
facility: CCBR Czech Prague, s.r.o.
city: Praha
country: Czechia
facility: Lekarna U Robina, s.r.o.
city: Uherske Hradiste
country: Czechia
facility: Lekarna Hradebni s.r.o.
city: Uherske Hradiste
country: Czechia
facility: MEDICAL PLUS, s.r.o.
city: Tbilisi
country: Georgia
facility: LTD Tbilisi Central Hospital
city: Tbilisi
country: Georgia
facility: LTD Unimedi Kakheti
city: Tbilisi
country: Georgia
facility: Tbilisi Heart and Vascular Clinic LTD
city: Tbilisi
country: Georgia
facility: LTD MediClubGeorgia
city: Tbilisi
country: Georgia
facility: LTD Adapti
city: Tbilisi
country: Georgia
facility: LTD Medulla" Chemotherapy and Immunotherapy Clinic
city: Berlin
country: Germany
facility: Schlosspark-Klinik
city: München
country: Germany
facility: Klinikum der Universität München
city: Olsberg
country: Germany
facility: Elisabeth-Klinik gGmbH
city: Puettlingen
country: Germany
facility: Knappschaftsklinikum Saar GmbH
city: Ratingen
country: Germany
facility: Rheumazentrum Ratingen
city: Guatemala
country: Guatemala
facility: Clínica Médica Especializada en Medicina Interna y Reumatología
city: Guatemala
country: Guatemala
facility: Clínica Médica especializada en Medicina Interna
city: Guatemala
country: Guatemala
facility: Centro de Nutricion y Rehabilitacion Cardiorespiratoria, S.A. (NUCARE)
city: Guatemala
country: Guatemala
facility: Therapeutic Research Institute and Lab S.A
city: Balatonfüred
country: Hungary
facility: DRC Gyógyszervizsgáló Központ Kft.
city: Budapest
country: Hungary
facility: Qualiclinic Kft.
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization, Hadassah Medical Center, Ein-Karem
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Anjo-shi
country: Japan
facility: Anjo Kosei Hospital
state: Aichi
city: Iiduka
country: Japan
facility: Aso Iizuka Hospital
state: Fukuoka
city: Takasaki
country: Japan
facility: Inoue Hospital
state: Gunma
city: Aki-gun
country: Japan
facility: Mazda Hospital
state: Hiroshima
city: Sapporo
country: Japan
facility: Sapporo City General Hospital
state: Hokkaido
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Katoh
country: Japan
facility: Matsubara Mayflower Hospital
state: Hyogo
city: Sagamihara
country: Japan
facility: National Hospital Organization Sagamihara National Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Yokohama Minami Kyosai Hospital
state: Kanagawa
city: Omura
country: Japan
facility: National Hospital Organization Nagasaki Medical Center
state: Nagasaki
city: Sasebo
country: Japan
facility: Sasebo Chuo Hospital
state: Nagasaki
city: Kurashiki
country: Japan
facility: Kurashiki Sweet Hospital
state: Okayama
city: Tomigusuku
country: Japan
facility: Yuaikai Tomishiro Central Hospital
state: Okinawa
city: Kawagoe-shi
country: Japan
facility: Saitama Medical Center
state: Saitama
city: Tokorozawa-shi
country: Japan
facility: Hirose Clinic
state: Saitama
city: Sunto-gun
country: Japan
facility: National Hospital Organization Shizuoka Medical Center
state: Shizuoka
city: Chuo-ku
country: Japan
facility: St. Luke's International Hospital
state: Tokyo
city: Meguro-ku
country: Japan
facility: Toho University Ohashi Medical Center
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Showa University Hospital
state: Tokyo
city: Chiba
country: Japan
facility: National Hospital Organization Chiba-East Hospital
city: Fukuoka
country: Japan
facility: Kondo clinic for rheumatism and orthopaedics
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Medical Center
city: Kumamoto
country: Japan
facility: Kumamoto Orthopaedic Hospital
city: Amman
country: Jordan
facility: Jordan Hospital
city: Irbid
country: Jordan
facility: King Abdullah University Hospital
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Kaunas
country: Lithuania
facility: LSMUL Kauno klinikos
city: San Luis De Potosí
country: Mexico
facility: Centro de Alta Especialidad en Reumatología e Investigación del Potosí, S.C.
state: SAN LUIS DE Potosi
city: Zona Universitaria
country: Mexico
facility: Unidad de Investigaciones Reumatológicas A.C - Hospital Central "Dr. Ignacio Morones Prieto"
state: SAN LUIS DE Potosi
city: Merida
country: Mexico
facility: Unidad Reumatologica Las Americas S.C.P
state: Yucatan
city: Salé
country: Morocco
facility: El Ayachi Hospital
city: Salé
country: Morocco
facility: Groupe Radiologique de Salé
city: Salé
country: Morocco
facility: Laboratoire les Arcades d'Analyses Médicales
city: San juan de Miraflores
country: Peru
facility: Hospital María Auxiliadora - Centro de Investigaciones Medicas
state: Lima
city: Santiago de Surco
country: Peru
facility: Instituto de Ginecología y Reproducción & Cirugía Mínimamente Invasiva
state: Lima
city: Arequipa
country: Peru
facility: Centro de diagnóstico por imágenes, Radiología General y Especial
city: Arequipa
country: Peru
facility: Unidad de Investigación en Medicina Interna y Enfermedades Críticas
city: Lima
country: Peru
facility: Centro de Investigación Reumatología CAA
city: Lima
country: Peru
facility: Clinica Medica Cayetano Heredia
city: Lima
country: Peru
facility: Servicio de Inmunología y Reumatología
city: Lipa City
country: Philippines
facility: Mary Mediatrix Medical Center
state: Batangas
city: Davao
country: Philippines
facility: Southern Philippines Medical Center
state: Davao DEL SUR
city: Makati
country: Philippines
facility: Makati Medical Center
state: Metro Manila
city: Manila
country: Philippines
facility: Medical Center Manila
city: Manila
country: Philippines
facility: Philippine General Hospital
city: Quezon
country: Philippines
facility: St. Luke's Medical Center
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w Bydgoszczy
city: Krakow
country: Poland
facility: Szpital Specjalistyczny im. J. Dietla Malopolskie Centrum Reumatologii Immunologii i Rehabilitacji
city: Nadarzyn
country: Poland
facility: NZOZ Lecznica MAK-MED. S.C.
city: Nowa Sol
country: Poland
facility: Twoja Przychodnia - Centrum Medyczne Nowa Sol
city: Warszawa
country: Poland
facility: MTZ Clinical Research Sp. z o.o.
city: Galati
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Galati "Sf. Apostol Andrei"
city: Iasi
country: Romania
facility: Spitalul Clinic de Recuperare Iasi
city: Targu Mures
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Targu Mures
city: Petrozavodsk
country: Russian Federation
facility: GBUZ "Republican hospital n.a. V.A.Baranov"
state: Republic OF Karelia
city: Kemerovo
country: Russian Federation
facility: GAUZ of Kemerovo Region "Regional clinical hospital for war veterans"
city: Krasnoyarsk
country: Russian Federation
facility: KGBUZ "Krasnoyarsk Interdistrict Clinical Hospital #20 n.a. I.S.Berzon"
city: Krasnoyarsk
country: Russian Federation
facility: Krasnoyarsk State Medical University n.a.Prof.V.F.Voyno-Yasenetsky
city: Kursk
country: Russian Federation
facility: GMU " Kursk regional clinical hospital" of the Committee of Healthcare of the Kursk region
city: Moscow
country: Russian Federation
facility: GBUZ of city of Moscow
city: Ryazan
country: Russian Federation
facility: GBOU VPO "Ryazan State medical university n.a. academician I.P.Pavlov"
city: Ryazan
country: Russian Federation
facility: GBOUVPO "Ryazan State Medical University n.a. Academician I.P.Pavlov"
city: Ryazan
country: Russian Federation
facility: GBU of Ryazan region "Regional clinical cardiology dispanser"
city: Ryazan
country: Russian Federation
facility: GBOU of Ryazan region "Regional clinical hospital"
city: Saint-Petersburg
country: Russian Federation
facility: Spb GBUZ "Clinical rheumatology hospital # 25" City CDC prevention of osteoporosis
city: Saratov
country: Russian Federation
facility: GUZ "Regional clinical hospital"
city: Vladimir
country: Russian Federation
facility: GBUZ VO 'Regional clinical hospital"
city: Yaroslavl
country: Russian Federation
facility: GBKUZ of Yaroslavl region "City hospital n. a. N.A. Semashko"
city: Belgrade
country: Serbia
facility: Clinical Hospital Center Bezanijska Kosa
city: Belgrade
country: Serbia
facility: Military Medical Academy
city: Niska Banja
country: Serbia
facility: Institute for Treatment and Rehabilitation "Niska Banja"
city: Johannesburg
country: South Africa
facility: Charlotte Maxeke Johannesburg Academic Hospital
state: Gauteng
city: Pretoria
country: South Africa
facility: Jakaranda Hospital
state: Gauteng
city: Pretoria
country: South Africa
facility: Emmed Research
state: Gauteng
city: Cape Town
country: South Africa
facility: Arthritis Clinical Research Unit
state: Western CAPE
city: Cape Town
country: South Africa
facility: Vincent Pallotti Hospital
state: Western CAPE
city: Manouba
country: Tunisia
facility: Mohamed Kassab Institute of orthopedics
city: Tunis
country: Tunisia
facility: Rabta Hospital
city: Dnipropetrovsk
country: Ukraine
facility: Derzhavna ustanova "Ukrainskyi derzhavnyi naukovo-doslidnyi instytut
city: Ivano-Frankivsk
country: Ukraine
facility: Oblasna klinichna likarnia, revmatolohichne viddilennia, Derzhavnyi vyshchyi navchalnyi zaklad
city: Kharkiv
country: Ukraine
facility: Komunalnyi zaklad okhorony zdorovia "Kharkivska miska klinichna likarnia #8"
city: Khmelnytskyi
country: Ukraine
facility: Khmelnytska oblasna likarnia
city: Kyiv
country: Ukraine
facility: Kyivska miska klinichna likarnia #6
city: Lviv
country: Ukraine
facility: Klinichnyi hospital Derzhavnoi prykordonnoi sluzhby Ukrainy
city: M. Kryvyi Rih
country: Ukraine
facility: Komunalnyi zaklad "Kryvorizka miska klinichna likarnia #2" Dnipropetrovskoi oblasnoi rady"
city: M. Sumy
country: Ukraine
facility: Komunalnyi zaklad Sumskoi oblasnoi rady "Sumska oblasna klinichna likarnia"
city: M. Vinnytsia
country: Ukraine
facility: Vinnytska oblasna klinichna likarnia im. M.I.Pyrohova, revmatolohichne
city: Odesa
country: Ukraine
facility: Komunalna ustanova "Odeska oblasna klinichna likarnia"
city: Odesa
country: Ukraine
facility: Bahatoprofilnyi medychnyi tsentr (Universytetska klinika #1)
city: Zaporizhzhia
country: Ukraine
facility: Komunalna ustanova "Zaporizka oblasna klinichna likarnia" Zaporizkoi oblasnoi rady
city: Wigan
country: United Kingdom
facility: Wrightington Hospital
state: Lancashire
city: Maidstone
country: United Kingdom
facility: Maidstone Hospital, Maidstone and Tunbridge wells NHS Trust
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.