Clinical trial NCT02480153: A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira®) In Combination With Methotrexate In Subjects With Active Rheumatoid Arthritis (REFLECTIONS B538-02).
Official title: A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB 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
adalimumab
rheumatoid arthritis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2015-06-24
Enrollment: 597
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, safety, and immunogenicity of PF-06410293 and adalimumab in combination with methotrexate in subjects with moderately to severly active rheumatoid arthritis who have had an inadequate response to methotrexate.

In an additional optional portion of the study, during open label Treatment Period 3 (TP3), a subset of subjects used a Prefilled Pen (PFP) to administer up to 3 injections of their study treatment (PF-06410293) at home.


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 8 mg/L.
* Must have received methotrexate for at least 12 weeks and been on a stable dose for at least 4 weeks prior to the first study dose.

Exclusion Criteria:

* Evidence of untreated or inadequately treated latent or active TB.
* Evidence of uncontrolled, clinically significant diseases, including moderate or severe heart failure (NYHA Class III/IV) or malignancy in the previous 5 years.
* History of infection requiring hospitalization or parenteral antimicrobial therapy within 6 months prior to first dose of study drug.
* May have received no more than 2 doses of one biologic therapy (other than adalimumab or lymphocyte depleting therapy).
* Any second DMARD must be washed out prior to the first study dose.

Primary outcomes:
measure: Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12: Period 1
timeFrame: Week 12
Secondary outcomes:
measure: Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Other Time Points Other Than Week 12: Period 1
timeFrame: Weeks 2, 4, 6, 8, 18 and 26 (pre-dose)
measure: Number of Participants With an American College of Rheumatology 20% (ACR20) Response: Period 2
timeFrame: Weeks 26, 30, 36, 44 and 52 (pre-dose)
measure: Number of Participants With an American College of Rheumatology 20% (ACR20) Response: Period 3
timeFrame: Weeks 52, 56, 66, 76 and 78
measure: Number of Participants With an American College of Rheumatology 50% (ACR50) Response: Period 1
timeFrame: Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
measure: Number of Participants With an American College of Rheumatology 50% (ACR50) Response: Period 2
timeFrame: Weeks 26, 30, 36, 44 and 52 (pre-dose)
measure: Number of Participants With an American College of Rheumatology 50% (ACR50) Response: Period 3
timeFrame: Weeks 52, 56, 66, 76 and 78
measure: Number of Participants With an American College of Rheumatology 70% (ACR70) Response: Period 1
timeFrame: Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
measure: Number of Participants With an American College of Rheumatology 70% (ACR70) Response: Period 2
timeFrame: Weeks 26, 30, 36, 44 and 52 (pre-dose)
measure: Number of Participants With an American College of Rheumatology 70% (ACR70) Response: Period 3
timeFrame: Weeks 52, 56, 66, 76 and 78
measure: Change From Baseline in Tender Joint Count: Period 1
timeFrame: Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
measure: Change From Baseline in Tender Joint Count: Period 2
timeFrame: Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)
measure: Change From Baseline in Tender Joint Count: Period 3
timeFrame: Baseline, Weeks 52, 56, 66, 76 and 78
measure: Change From Baseline in Swollen Joint Count: Period 1
timeFrame: Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
measure: Change From Baseline in Swollen Joint Count: Period 2
timeFrame: Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)
measure: Change From Baseline in Swollen Joint Count: Period 3
timeFrame: Baseline, Weeks 52, 56, 66, 76 and 78
measure: Change From Baseline in Physician's Global Assessment of Arthritis (PGAA): Period 1
timeFrame: Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
measure: Change From Baseline in Physician's Global Assessment of Arthritis (PGAA): Period 2
timeFrame: Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)
measure: Change From Baseline in Physician's Global Assessment of Arthritis (PGAA): Period 3
timeFrame: Baseline, Weeks 52, 56, 66, 76 and 78
measure: Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP): Period 1
timeFrame: Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
measure: Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP): Period 2
timeFrame: Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)
measure: Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP): Period 3
timeFrame: Baseline, Weeks 52, 56, 66, 76 and 78
measure: Change From Baseline in Patient's Global Assessment of Arthritis (PGA): Period 1
timeFrame: Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
measure: Change From Baseline in Patient's Global Assessment of Arthritis (PGA): Period 2
timeFrame: Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)
measure: Change From Baseline in Patient's Global Assessment of Arthritis (PGA): Period 3
timeFrame: Baseline, Weeks 52, 56, 66, 76 and 78
measure: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI): Period 1
timeFrame: Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
measure: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI): Period 2
timeFrame: Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)
measure: Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI): Period 3
timeFrame: Baseline, Weeks 52, 56, 66, 76 and 78
measure: Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP): Period 1
timeFrame: Baseline, Weeks1, 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
measure: Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP): Period 2
timeFrame: Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)
measure: Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP): Period 3
timeFrame: Baseline, Weeks 52, 56, 66, 76 and 78
measure: Change From Baseline in Disease Activity Score-28 (4 Components Based on High-Sensitivity C-Reactive Protein) (DAS28-4 [CRP]): Period 1
timeFrame: Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
measure: Change From Baseline in Disease Activity Score-28 (4 Components Based on High-Sensitivity C-Reactive Protein) (DAS28-4 [CRP]): Period 2
timeFrame: Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)
measure: Change From Baseline in Disease Activity Score-28 (4 Components Based on High-Sensitivity C-Reactive Protein) (DAS28-4 [CRP]): Period 3
timeFrame: Baseline, Weeks 52, 56, 66, 76 and 78
measure: Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 1
timeFrame: Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
measure: Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 2
timeFrame: Weeks 26, 30, 36, 44 and 52 (pre-dose)
measure: Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 3
timeFrame: Weeks 52, 56, 66, 76 and 78
measure: Number of Participants Achieving Disease Activity Score Remission (DAS <2.6): Period 1
timeFrame: Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
measure: Number of Participants Achieving Disease Activity Score Remission (DAS <2.6): Period 2
timeFrame: Weeks 26, 30, 36, 44 and 52 (pre-dose)
measure: Number of Participants Achieving Disease Activity Score Remission (DAS <2.6): Period 3
timeFrame: Weeks 52, 56, 66, 76 and 78
measure: Number of Participants Achieving American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Response：Period 1
timeFrame: Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
measure: Number of Participants Achieving American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Response: Period 2
timeFrame: Weeks 26, 30, 36, 44 and 52 (pre-dose)
measure: Number of Participants Achieving American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Response: Period 3
timeFrame: Weeks 52, 56, 66, 76 and 78
measure: Serum Concentration Versus Time Summary: Period 1
timeFrame: Pre-dose on Days 1, 15, 43, 85 and 183, and at any time during Day 8 visit
measure: Serum Concentration Versus Time Summary: Period 2
timeFrame: Pre-dose on Days 183, 211, 253 and 365
measure: Serum Concentration Versus Time Summary: Period 3
timeFrame: Pre-dose on Days 365, 393, 463, 547 and 575
measure: Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (NAb): Period 1
timeFrame: Baseline up to Week 26 (pre-dose)
measure: Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (NAb): Period 2
timeFrame: Week 26 dosing up to Week 52 (pre-dose)
measure: Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (NAb): Period 3
timeFrame: Week 52 dosing up to follow-up visit (Week 92)
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 26 (pre-dose)
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 2
timeFrame: Week 26 dosing up to Week 52 (pre-dose)
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 3
timeFrame: Week 52 dosing up to follow-up visit (Week 92)
measure: Number of Participants With Laboratory Abnormalities: Period 1
timeFrame: Baseline (Day 1) up to Week 26 (pre-dose)
measure: Number of Participants With Laboratory Abnormalities: Period 2
timeFrame: Week 26 dosing up to Week 52 (pre-dose)
measure: Number of Participants With Laboratory Abnormalities: Period 3
timeFrame: Week 52 dosing up to follow-up visit (Week 92)
Other outcomes:
measure: Percentage of Participants Who Achieved Delivery Success in Sub-study
timeFrame: Weeks 56, 58, 60, 62, 64, 66
Locations:
city: Gilbert
country: United States
facility: ArthroCare, Arthritis Care & Research P.C.
state: Arizona
city: Glendale
country: United States
facility: Arizona Arthritis & Rheumatology Associates, PC
state: Arizona
city: Phoenix
country: United States
facility: Arizona Arthritis & Rheumatology Associates, PC
state: Arizona
city: Fullerton
country: United States
facility: St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare
state: California
city: San Leandro
country: United States
facility: East Bay Rheumatology Medical Group, Inc.
state: California
city: Thousand Oaks
country: United States
facility: Westlake Medical Research
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: Clearwater
country: United States
facility: Robert W. Levin, MD, PA
state: Florida
city: Daytona Beach
country: United States
facility: International Medical Research
state: Florida
city: Gainesville
country: United States
facility: SIMED Arthritis Center
state: Florida
city: Gainesville
country: United States
facility: Southeastern Integrated Medical, PL, d/b/a Florida Medical Research
state: Florida
city: Orlando
country: United States
facility: Rheumatology Associates of Central Florida, P.A.
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: Boise
country: United States
facility: St Luke's Intermountain Research Center
state: Idaho
city: Meridian
country: United States
facility: St Luke' s Clinic
state: Idaho
city: Cedar Rapids
country: United States
facility: Physician's Clinic of Iowa, P.C.
state: Iowa
city: Bowling Green
country: United States
facility: Graves-Gilbert Clinic Bowling Green
state: Kentucky
city: Wheaton
country: United States
facility: The Center for Rheumatology and Bone Research
state: Maryland
city: Battle Creek
country: United States
facility: Bronson Internal Medicine and Rheumatology
state: Michigan
city: Tupelo
country: United States
facility: North Mississippi Medical Clinics, Inc. - Clinical Research
state: Mississippi
city: Lincoln
country: United States
facility: Physician Research Collaboration, LLC
state: Nebraska
city: Omaha
country: United States
facility: Westroads Clinical Research, Inc.
state: Nebraska
city: Voorhees
country: United States
facility: Arthritis, Rheumatic & Back Disease Associates, P.A.
state: New Jersey
city: New York
country: United States
facility: Manhattan Medical Research
state: New York
city: Orchard Park
country: United States
facility: Buffalo Rheumatology and Medicine PLLC
state: New York
city: Greenville
country: United States
facility: Physicians East PA
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Rheumatic Disease Study Group, Inc.
state: Ohio
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Wyomissing
country: United States
facility: Clinical Research 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 - Rheumatology
state: South Dakota
city: Jackson
country: United States
facility: West Tennessee Research Institute
state: Tennessee
city: Memphis
country: United States
facility: Ramesh C Gupta, M.D.
state: Tennessee
city: Amarillo
country: United States
facility: Amarillo Center for Clinical Research, Ltd.
state: Texas
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: The Clinical Research Institute of Houston, LLC
state: Texas
city: League City
country: United States
facility: Accurate Clinical Research
state: Texas
city: Mesquite
country: United States
facility: Southwest Rheumatology Research, LLC
state: Texas
city: Shenandoah
country: United States
facility: Northwest Diagnostic Clinic, PA
state: Texas
city: Chesapeake
country: United States
facility: Center for Arthritis and Rheumatic Diseases, P.C.
state: Virginia
city: Wenatchee
country: United States
facility: Wenatchee Valley Hospitals & Clinics
state: Washington
city: Beckley
country: United States
facility: Rheumatology and Pulmonary Clinic
state: West Virginia
city: Southport
country: Australia
facility: Paradise Arthritis & Rheumatology Pty Ltd
state: Queensland
city: Woodville South
country: Australia
facility: The Queen Elizabeth Hospital
state: South Australia
city: Victoria Park
country: Australia
facility: RK Will Pty Ltd
state: Western Australia
city: Curitiba
country: Brazil
facility: EDUMED Educação em Saúde S/S Ltda
state: Paraná
city: Plovdiv
country: Bulgaria
facility: MHAT Plovdiv AD
city: Plovdiv
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment (UMHAT) Kaspela EOOD
city: Sofia
country: Bulgaria
facility: UMHAT "Sv. Ivan Rilski" EAD
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment "Sv. Ivan Rilski" EAD
city: Bogota
country: Colombia
facility: Fundacion Instituto de Reumatologia Fernando Chalem
city: Bruntal
country: Czechia
facility: Lekarna Na vrsku
city: Bruntal
country: Czechia
facility: Revmatologie Bruntal, s.r.o.
city: Hlucin
country: Czechia
facility: L.K.N. Arthrocentrum, s.r.o.
city: Ostrava
country: Czechia
facility: Lekarna Vesalion
city: Pardubice
country: Czechia
facility: Benu Lekarna
city: Pardubice
country: Czechia
facility: CCBR-SYNARC, a.s.
city: Praha 2
country: Czechia
facility: Revmatologicky ustav
city: Uherske Hradiste
country: Czechia
facility: Lekarna Hradebni s.r.o.
city: Uherske Hradiste
country: Czechia
facility: MEDICAL PLUS, s.r.o.
city: Tallinn
country: Estonia
facility: Innomedica OÜ
city: Tallinn
country: Estonia
facility: East Tallinn Central Hospital
city: Batumi
country: Georgia
facility: LTD "Unimed Adjara"
state: Ajaria
city: Telavi
country: Georgia
facility: Unimedi Kakheti Ltd, Telavi Referral Hospital
state: Kakheti
city: Tbilisi
country: Georgia
facility: V.Tsitlanadze Scientifically-Practical Rheumatology Center LTD
city: Tbilisi
country: Georgia
facility: V.Tsitlanadze Scientifically-Practical Rheumatology Center
city: Tbilisi
country: Georgia
facility: LTD Israeli-Georgian Medical Research Clinic Helsicore"
city: Tbilisi
country: Georgia
facility: LTD Cardio-Reanimation Center
city: Tbilisi
country: Georgia
facility: Tbilisi Heart and Vascular Clinic LTD
city: Tbilisi
country: Georgia
facility: LTD Altravita
city: Tbilisi
country: Georgia
facility: LTD.MediClubGeorgia
city: Tbilisi
country: Georgia
facility: JSC Medical Corporation Evex
city: Berlin
country: Germany
facility: Schlosspark-Klinik
city: Hildesheim
country: Germany
facility: Gemeinschaftspraxis Dr. von Hinüber/Dr. Demary
city: München
country: Germany
facility: Klinikum der Universität München
city: München
country: Germany
facility: Praxiszentrum St. Bonifatius
city: Planegg
country: Germany
facility: Rheumapraxis Dr. Martin Welcker und Kollegen
city: Püttlingen
country: Germany
facility: Knappschaftsklinikum Saar GmbH
city: Ratingen
country: Germany
facility: Rheumazentrum Ratingen
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Központ
state: Hajdú-bihar
city: Budapest
country: Hungary
facility: Qualiclinic Kft.
city: Veszprem
country: Hungary
facility: Vital Medical Center Orvosi es Fogorvosi Kozpont
city: Anjo-shi
country: Japan
facility: Anjo Kosei Hospital
state: Aichi
city: Takasaki
country: Japan
facility: Inoue Hospital
state: Gunma
city: Asahikawa
country: Japan
facility: National Hospital Organization Asahikawa Medical Center
state: Hokkaido
city: Asahikawa
country: Japan
facility: Katayama Orthopaedic Rheumatology Clinic
state: Hokkaido
city: Sapporo
country: Japan
facility: Sapporo City General Hospital
state: Hokkaido
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Kato
country: Japan
facility: Matsubara Mayflower Hospital
state: Hyogo
city: Omura
country: Japan
facility: National Hospital Organization Nagasaki Medical Center
state: Nagasaki
city: Kawagoe
country: Japan
facility: Saitama Medical Center
state: Saitama
city: Tokorozawa
country: Japan
facility: Hirose Clinic
state: Saitama
city: Fukuoka
country: Japan
facility: Kondo clinic for rheumatism and orthopaedics
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Medical Center
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: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
city: Kaunas
country: Lithuania
facility: LSMUL Kauno klinikos
city: Klaipeda
country: Lithuania
facility: Klaipedos universitetine ligonine
city: Vilnius
country: Lithuania
facility: Vilniaus universiteto ligonines Santariskiu klinikos
city: Mexicali
country: Mexico
facility: Consultorio Medico Privado de Reumatologia
state: BAJA California
city: Ciudad de Mexico
country: Mexico
facility: Consultorio de Reumatologia
city: Timaru
country: New Zealand
facility: MedLab
state: South Canterbury
city: Timaru
country: New Zealand
facility: Timaru Hospital
state: South Canterbury
city: Timaru
country: New Zealand
facility: Timaru Rheumatology Studies
state: South Canterbury
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Wellington
country: New Zealand
facility: Wellington Hospital, Capital Coast District Health Board
city: Arequipa, Arequipa
country: Peru
facility: Oficina administrativa
city: Arequipa
country: Peru
facility: Unidad de Investigacion en Medicina Interna y Enfermedades Criticas
city: Lima, Lima
country: Peru
facility: Oficina Administrativa
city: Lima
country: Peru
facility: ABK REUMA SRL-Medicentro Biociencias Peru SRL
city: Lima
country: Peru
facility: Clinica Medica Cayetano Heredia
city: Lima
country: Peru
facility: Centro de Investigación para el Estudio de Enfermedades Reumáticas
city: Lima
country: Peru
facility: Instituto de Ginecología y Reproducción & Cirugía Mínimamente Invasiva
city: Bialystok
country: Poland
facility: Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk
city: Bialystok
country: Poland
facility: NZOZ Zdrowie Osteo-Medic s.c.
city: Elblag
country: Poland
facility: Centrum Kliniczno-Badawcze J.Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka Partnerska
city: Elblag
country: Poland
facility: NZOZ Centrum Reumatologiczne Indywidualna Specjalistyczna Praktyka Lekarska Lek. med. Barbara Bazela
city: Gdynia
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Gdyni
city: Katowice
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Katowicach
city: Katowice
country: Poland
facility: Centrum Medyczne Pratia Katowice
city: Lublin
country: Poland
facility: Zespol Poradni Specjalistycznych "REUMED" Filia nr 2
city: Nadarzyn
country: Poland
facility: NZOZ Lecznica MAK-MED. S.C.
city: Poznan
country: Poland
facility: Prywatna Praktyka Lekarska Prof. UM Dr Hab. Med. Pawel Hrycaj
city: Torun
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej ''Nasz Lekarz''
city: Warszawa
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Warszawie
city: Warszawa
country: Poland
facility: Centrum Medyczne AMED
city: Warszawa
country: Poland
facility: MTZ Clinical Research Sp. z o.o.
city: Warszawa
country: Poland
facility: ''Rheuma Medicus'' Zakład Opieki Zdrowotnej
city: Wroclaw
country: Poland
facility: Synexus Polska Sp. z o.o. Oddział we Wroclawiu
city: Petrozavodsk
country: Russian Federation
facility: GBUZ Republican hospital n.a. V.A. Baranov
state: Republic OF Karelia
city: Izhevsk
country: Russian Federation
facility: LLC Alliance Biomedical Ural group
city: Kemerovo
country: Russian Federation
facility: GAUZ of Kemerovo Region "Regional clinical hospital for war veterans"
city: Kursk
country: Russian Federation
facility: GMU Kursk Regional Clinical Hospital of the Healthcare Committee of the Kursk Region
city: Moscow
country: Russian Federation
facility: Municipal Clinical Hospital No. 1 Named after N.I. Pirogov
city: Moscow
country: Russian Federation
facility: GBUZ of city of Moscow City clinical hospital n.a. A.K.Eramishantsev of Ministry of Healthcare of
city: Orenburg
country: Russian Federation
facility: Orenburg State Medical Academy
city: Orenburg
country: Russian Federation
facility: Regional Clinical Hospital
city: Ryazan
country: Russian Federation
facility: GBOU VPO Ryazan State Medical University Named after Academician I.P. Pavlov
city: Ryazan
country: Russian Federation
facility: GBU of Ryazan region Regional clinical cardiology dispanser
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: Institute of Rheumatology
city: Belgrade
country: Serbia
facility: Military Medical Academy,
city: Niska Banja
country: Serbia
facility: Institute for Treatment and Rehabilitation Niska Banja
city: Novi Sad
country: Serbia
facility: Special Hospital for Rheumatic Diseases Novi Sad
city: Johannesburg
country: South Africa
facility: Charlotte Maxeke Johannesburg Academic Hospital
state: Gauteng
city: Kempton Park
country: South Africa
facility: Clinresco Centres (Pty) Ltd
state: Gauteng
city: Durban
country: South Africa
facility: St. Augustine's Hospital
state: Kwa-zulu Natal
city: Cape Town
country: South Africa
facility: Arthritis Clinical Research Trials, Dr. C.E Spargo and Dr. R.B Bhorat Practice
state: Western CAPE
city: Cape Town
country: South Africa
facility: Panorama Medical Centre
state: Western CAPE
city: Fuenlabrada
country: Spain
facility: Hospital Universitario de Fuenlabrada
state: Madrid
city: Barakaldo
country: Spain
facility: Hospital Universitario Cruces
state: Vizcaya
city: A Coruña
country: Spain
facility: Hospital Universitario A Coruña
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Sevilla
country: Spain
facility: Hospital Infanta Luisa
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taipei
country: Taiwan
facility: Taipei Medical University Hospital
city: Kyiv
country: Ukraine
facility: Kyivska miska klinichna likarnia #6
city: Lviv
country: Ukraine
facility: Lvivskyi oblasnyi klinichnyi diahnostychnyi tsentr,
city: Lviv
country: Ukraine
facility: Komunalna 4-a miska klinichna likarnia m. Lvova,
city: M. Kharkiv
country: Ukraine
facility: Komunalnyi zaklad okhorony zdorovia "Kharkivska miska klinichna likarnia #8"
city: M. Kyiv,
country: Ukraine
facility: Komunalnyi zaklad Kyivskoi oblasnoi rady "Kyivska oblasna klinichna likarnia",
city: Odesa
country: Ukraine
facility: Bahatoprofilnyi medychnyi tsentr (Universytetska klinika #1)
city: Sumy
country: Ukraine
facility: Komunalnyi zaklad Sumskoi oblasnoi rady "Sumska oblasna klinichna
city: Vinnytsia
country: Ukraine
facility: Vinnytska oblasna klinichna likarnia im. M.I.Pyrohova revmatolohichne viddilennia
city: Zaporizhzhia
country: Ukraine
facility: Komunalna ustanova "Zaporizka oblasna klinichna likarnia" Zaporizkoi oblasnoi rady
city: Basingstoke
country: United Kingdom
facility: Basingstoke and North Hampshire Hospital, Hampshire Hospitals NHS Foundation Trust
state: Hampshire
city: Wirral
country: United Kingdom
facility: Arrowe Park Hospital, Wirral University Teaching Hospitals NHS Foundation Trust
state: Merseyside
city: Bath
country: United Kingdom
facility: Royal United Hospital Bath NHS Foundation Trust ,Royal National Hospital for Rheumatic Diseases
state: Somerset
city: Leeds
country: United Kingdom
facility: The Leeds Institute of Rheumatic and Musculoskeletal Medicine
state: WEST Yorkshire
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: Fleischmann RM, Bock AE, Zhang W, Godfrey CM, Vranic I, Cronenberger C, Dokoupilova E. Usability Study of PF-06410293, an Adalimumab Biosimilar, by Prefilled Pen: Open-Label, Single-Arm, Sub-Study of a Phase 3 Trial in Patients with Rheumatoid Arthritis. Rheumatol Ther. 2022 Jun;9(3):839-850. doi: 10.1007/s40744-022-00439-8. Epub 2022 Mar 18.
citation: Fleischmann RM, Alvarez DF, Bock AE, Cronenberger C, Vranic I, Zhang W, Alten R. Long-term efficacy, safety, and immunogenicity of the adalimumab biosimilar, PF-06410293, in patients with rheumatoid arthritis after switching from reference adalimumab (Humira(R)) or continuing biosimilar therapy: week 52-92 data from a randomized, double-blind, phase 3 trial. Arthritis Res Ther. 2021 Sep 25;23(1):248. doi: 10.1186/s13075-021-02626-4.
citation: Fleischmann RM, Alvarez DF, Bock AE, Cronenberger C, Vranic I, Zhang W, Alten R. Randomised study of PF-06410293, an adalimumab (ADL) biosimilar, compared with reference ADL for the treatment of active rheumatoid arthritis: results from weeks 26-52, including a treatment switch from reference ADL to PF-06410293. RMD Open. 2021 Apr;7(2):e001578. doi: 10.1136/rmdopen-2021-001578.
citation: Huizinga TWJ, Torii Y, Muniz R. Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity. Rheumatol Ther. 2021 Mar;8(1):41-61. doi: 10.1007/s40744-020-00259-8. Epub 2020 Dec 1.
citation: Fleischmann RM, Alten R, Pileckyte M, Lobello K, Hua SY, Cronenberger C, Alvarez D, Bock AE, Sewell KL. A comparative clinical study of PF-06410293, a candidate adalimumab biosimilar, and adalimumab reference product (Humira(R)) in the treatment of active rheumatoid arthritis. Arthritis Res Ther. 2018 Aug 15;20(1):178. doi: 10.1186/s13075-018-1676-y.