Clinical trial NCT02092467: Safety Study Of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid Arthritis
Official title: PHASE 3B/4 RANDOMIZED SAFETY ENDPOINT STUDY OF 2 DOSES OF TOFACITINIB IN COMPARISON TO A TUMOR NECROSIS FACTOR (TNF) INHIBITOR IN SUBJECTS WITH RHEUMATOID ARTHRITIS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Arthritis, Rheumatoid
Keywords: Post-marketing
Phase 4
Open-label
Safety Surveillance
CP690550
Xeljanz
oral treatment
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-03-20
Enrollment: 4372
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This post-marketing study is designed to compare the safety of tofacitinib versus TNF inhibitor with respect to major cardiovascular adverse events and malignancies, excluding non-melanoma skin cancers when given to subjects with rheumatoid arthritis. Other safety events, including non-melanoma skin cancers, hepatic events, infections, and efficacy parameters will be collected and evaluated in the study.


Eligibility criteria: Inclusion Criteria:

* Moderate to severe rheumatoid arthritis
* Taking methotrexate without adequate control of symptoms
* Have at least one cardiovascular risk factor (eg, current smoker, high blood pressure, high cholesterol levels, diabetes mellitus, history of heart attack, family history of coronary heart disease, extra-articular RA disease)

Exclusion Criteria:

* Current or recent infection
* Clinically significant laboratory abnormalities
* Pregnancy

Primary outcomes:
measure: Incidence Rate of Adjudicated Malignancies Excluding Non-melanoma Skin Cancers (NMSC)
timeFrame: Baseline up to last contact date (maximum up to 72 months)
measure: Incidence Rate of Adjudicated Major Adverse Cardiovascular Events (MACE)
timeFrame: Baseline up to last contact date (maximum up to 72 months)
Secondary outcomes:
measure: Incidence Rate of Non-fatal Stroke
timeFrame: Baseline up to last contact date (maximum up to 72 months)
measure: Incidence Rate of Non-fatal Myocardial Infarction
timeFrame: Baseline up to last contact date (maximum up to 72 months)
measure: Incidence Rate of Adjudicated Opportunistic Infection Events Including Tuberculosis
timeFrame: Baseline up to last contact date (maximum up to 72 months)
measure: Incidence Rate of Adjudicated Hepatic Events
timeFrame: Baseline up to last contact date (maximum up to 72 months)
measure: Incidence Rate of Adjudicated Cardiovascular Events Other Than Major Adverse Cardiovascular Events (MACE)
timeFrame: Baseline up to last contact date (maximum up to 72 months)
measure: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: AEs: Baseline up to minimum of last contact date or last study treatment dose date+28 days (maximum up to 72 months); SAEs: Baseline up to minimum of last contact date (maximum up to 72 months)
measure: Number of Participants With Clinically Significant Abnormal Laboratory Parameters
timeFrame: Baseline up to last contact date (maximum up to 72 months)
measure: Incidence Rate of Adjudicated All-Cause Deaths
timeFrame: Baseline up to last contact date (maximum up to 72 months)
measure: Number of Participants With Reasons For Permanent or Temporary Discontinuation of Study Medication
timeFrame: Baseline up to last contact date (maximum up to 72 months)
measure: Change From Baseline in Disease Activity Score 28-4 (DAS28-4) C-reactive Protein (CRP) at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63
timeFrame: Baseline, Months 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63
measure: Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63
timeFrame: Baseline, Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63
measure: Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63
timeFrame: Baseline, Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63
measure: Percentage of Participants Who Achieved Observed American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) Boolean Remission Criteria
timeFrame: Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69 and 72
measure: Percentage of Participants With Simplified Disease Activity Index (SDAI) Less Than or Equal to (<=) 3.3
timeFrame: Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69 and 72
measure: Percentage of Participants With Clinical Disease Activity Index (CDAI) <=2.8
timeFrame: Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69 and 72
measure: Percentage of Participants With Simplified Disease Activity Index (SDAI) <=11
timeFrame: Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69 and 72
measure: Percentage of Participants With Clinical Disease Activity Index (CDAI) <=10
timeFrame: Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69 and 72
measure: Percentage of Participants With Disease Activity Score 28-4 (DAS28-4) C-reactive Protein (CRP) <=3.2
timeFrame: Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69 and 72
measure: Number of Participants With an American College of Rheumatology 20 Percent (%) (ACR20) Response
timeFrame: Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69 and 72
measure: Number of Participants With an American College of Rheumatology 50% (ACR50) Response
timeFrame: Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69 and 72
measure: Number of Participants With an American College of Rheumatology 70% (ACR70) Response
timeFrame: Month 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69 and 72
measure: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Months 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63
timeFrame: Baseline, Months 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60 and 63
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham (UAB), Arthritis Clinical Intervention Program
state: Alabama
city: Huntsville
country: United States
facility: Rheumatology Associates of North Alabama, PC
state: Alabama
city: Tuscaloosa
country: United States
facility: Clinical and Translational Research Center of Alabama, PC
state: Alabama
city: Tucson
country: United States
facility: Southern Arizona VA Health Care System (SAVAHCS)
state: Arizona
city: Tucson
country: United States
facility: University of Arizona Clinical and Translational Science Research Center
state: Arizona
city: Hot Springs
country: United States
facility: CHI St. Vincent Medical Group Hot Springs
state: Arkansas
city: Jonesboro
country: United States
facility: Arthritis And Rheumatism Associates LLC
state: Arkansas
city: Covina
country: United States
facility: Medvin Clinical Research
state: California
city: Fair Oaks
country: United States
facility: Med Investigations, Inc.
state: California
city: Huntington Beach
country: United States
facility: Talbert Medical Group
state: California
city: La Jolla
country: United States
facility: University of California, San Diego (UCSD)- Perlman Ambulatory Clinic
state: California
city: Long Beach
country: United States
facility: Valerius Medical Group And Research Center Of Greater Long Beach, Inc.
state: California
city: Long Beach
country: United States
facility: ProHealth Partners
state: California
city: Los Angeles
country: United States
facility: Keck Medicine of USC
state: California
city: Northridge
country: United States
facility: California Medical Research Associates Inc
state: California
city: Palm Desert
country: United States
facility: Desert Medical Advances
state: California
city: Placentia
country: United States
facility: Medvin Clinical Research
state: California
city: Roseville
country: United States
facility: Sierra Rheumatology, Inc.
state: California
city: San Diego
country: United States
facility: San Diego Arthritis Medical Clinic
state: California
city: Santa Monica
country: United States
facility: Dr. Orrin M. Troum, Md And Medical Associates
state: California
city: Torrance
country: United States
facility: Los Angeles Biomedical Research Institute at Harbor UCLA Medical Center
state: California
city: Torrance
country: United States
facility: Harbor UCLA Medical Center
state: California
city: Tustin
country: United States
facility: Robin K. Dore M.D., Inc.
state: California
city: Van Nuys
country: United States
facility: Medvin Clinical Research
state: California
city: Ventura
country: United States
facility: Ventura Clinical Trials
state: California
city: Victorville
country: United States
facility: Desert Valley Medical Group
state: California
city: Whittier
country: United States
facility: Medvin Clinical Research
state: California
city: Colorado Springs
country: United States
facility: Arthritis Associates and Osteoporosis Center of Colorado Springs
state: Colorado
city: Washington
country: United States
facility: Howard University Hospital
state: District of Columbia
city: Boca Raton
country: United States
facility: RASF-Clinical Research Center, Inc
state: Florida
city: Brandon
country: United States
facility: Bay Area Arthritis and Osteoporosis
state: Florida
city: Clearwater
country: United States
facility: Arthritis & Rheumatism Associates (Private Practice)
state: Florida
city: Clearwater
country: United States
facility: Florida Clinical Research Group (Administrative Office)
state: Florida
city: Clearwater
country: United States
facility: Dr.Robert W. Levin MDOffice of
state: Florida
city: Daytona Beach
country: United States
facility: International Medical Research
state: Florida
city: Fort Lauderdale
country: United States
facility: Centre for Rheumatology, Immunology and Arthritis
state: Florida
city: Jacksonville
country: United States
facility: University of Florida - Rheumatology at ACC
state: Florida
city: Jacksonville
country: United States
facility: University of Florida College of Medicine, Jacksonville - Rheumatology Research
state: Florida
city: Miami Lakes
country: United States
facility: San Marcus Research Clinic
state: Florida
city: Miami
country: United States
facility: Doctors Research Institute
state: Florida
city: Miami
country: United States
facility: Center for Arthritis and Rheumatic Diseases
state: Florida
city: Ocala
country: United States
facility: Ocala Rheumatology Research Center
state: Florida
city: Ocoee
country: United States
facility: Advanced Clinical Research of Orlando
state: Florida
city: Orange Park
country: United States
facility: Arthritis & osteoporosis treatment center,PA
state: Florida
city: Orlando
country: United States
facility: Rheumatology Associates of Central Florida, PA
state: Florida
city: Orlando
country: United States
facility: Omega Research Consultants, LLC
state: Florida
city: Ormond Beach
country: United States
facility: Millennium Research
state: Florida
city: Palm Harbor
country: United States
facility: Arthritis Center, Inc.
state: Florida
city: Palm Harbor
country: United States
facility: Arthritis Research of Florida, Inc.
state: Florida
city: Port Orange
country: United States
facility: Advanced Medical Research Center
state: Florida
city: Port Orange
country: United States
facility: Advanced Urgent Care
state: Florida
city: Tampa
country: United States
facility: USF Health Morsani Center for Advanced Healthcare
state: Florida
city: Zephyrhills
country: United States
facility: Florida Medical Clinic, P.A.
state: Florida
city: Atlanta
country: United States
facility: Arthritis and Rheumatology of GA, P.C.
state: Georgia
city: Canton
country: United States
facility: Medical Associates of North Georgia - Rheumatology
state: Georgia
city: Decatur
country: United States
facility: Office of Jefrey D. Lieberman, MD, PC
state: Georgia
city: Coeur d'Alene
country: United States
facility: Coeur D'Alene Arthritis Clinic
state: Idaho
city: Quincy
country: United States
facility: Quincy Medical Group
state: Illinois
city: Springfield
country: United States
facility: Springfield Clinic
state: Illinois
city: Indianapolis
country: United States
facility: Diagnostic Rheumatology and Research PC
state: Indiana
city: Overland Park
country: United States
facility: MidWest Clinical Research, LLC
state: Kansas
city: Wichita
country: United States
facility: Professional Research Network of Kansas, LLC
state: Kansas
city: Monroe
country: United States
facility: Arthritis and Diabetes Clinic, Inc.
state: Louisiana
city: Cumberland
country: United States
facility: Klein & Associates, M.D.,P.A.
state: Maryland
city: Frederick
country: United States
facility: Arthritis Treatment Center
state: Maryland
city: Hagerstown
country: United States
facility: Klein & Associates, MD, PA
state: Maryland
city: Wheaton
country: United States
facility: The Center for Rheumatology and Bone Research, a division of Arthritis and Rheumatism Associates, PC
state: Maryland
city: Fall River
country: United States
facility: Phase III Clinical Research
state: Massachusetts
city: Worcester
country: United States
facility: UMass Memorial Medical Center, Memorial Campus
state: Massachusetts
city: Battle Creek
country: United States
facility: Bronson Healthcare Group
state: Michigan
city: Kalamazoo
country: United States
facility: Bronson Rheumatology Specialists
state: Michigan
city: Kalamazoo
country: United States
facility: Jasper Clinic, Inc.
state: Michigan
city: Kalamazoo
country: United States
facility: Western Michigan University Homer Stryker M.D. School of Medicine Center for Clinical Research
state: Michigan
city: Kalamazoo
country: United States
facility: Borgess Medical Center
state: Michigan
city: Kalamazoo
country: United States
facility: Borgess Research Institute
state: Michigan
city: Lansing
country: United States
facility: June DO,PC
state: Michigan
city: Saint Clair Shores
country: United States
facility: Shores Rheumatology P.C.
state: Michigan
city: Eagan
country: United States
facility: St. Paul Rheumatology, PA
state: Minnesota
city: Mendota Heights
country: United States
facility: Center for Diagnostic Imaging
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Kansas City
country: United States
facility: Kansas City Internal Medicine
state: Missouri
city: Springfield
country: United States
facility: Clinvest Research, LLC
state: Missouri
city: Kalispell
country: United States
facility: Glacier View Research Institute
state: Montana
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: Las Vegas
country: United States
facility: University of Nevada School of Medicine
state: Nevada
city: Las Vegas
country: United States
facility: Steinberg Diagnostics
state: Nevada
city: Las Vegas
country: United States
facility: EKSAKTI, LLC (dba: Eksakti Clinical Research)
state: Nevada
city: Reno
country: United States
facility: Arthritis Center Of Reno
state: Nevada
city: Nashua
country: United States
facility: Nashua Rheumatology
state: New Hampshire
city: Clifton
country: United States
facility: Summit Medical Group
state: New Jersey
city: Brooklyn
country: United States
facility: Weill Cornell Physicians at Brooklyn Heights
state: New York
city: Great Neck
country: United States
facility: Northwell Health Division of Rheumatology
state: New York
city: Lake Success
country: United States
facility: NYU Langone Rheumatology Associates Long Island.
state: New York
city: Durham
country: United States
facility: EmergeOrtho,P.A.
state: North Carolina
city: Greenville
country: United States
facility: Physicians East, PA
state: North Carolina
city: Hickory
country: United States
facility: PMG Research of Hickory LLC
state: North Carolina
city: Hickory
country: United States
facility: Frycare outpatient imaging Center
state: North Carolina
city: Hickory
country: United States
facility: PMG Research of Hickory, LLC
state: North Carolina
city: Statesville
country: United States
facility: PMG Research Inc., d/b/a PMG Research of Piedmont HealthCare
state: North Carolina
city: Wilmington
country: United States
facility: Carolina Arthritis Associates
state: North Carolina
city: Bismarck
country: United States
facility: St. Alexius Medical Center
state: North Dakota
city: Minot
country: United States
facility: Trinity Health Center - Medical Arts
state: North Dakota
city: Cincinnati
country: United States
facility: Cincinnati Rheumatic Disease Study Group, Inc.
state: Ohio
city: Dayton
country: United States
facility: STAT Research, Inc.
state: Ohio
city: Oklahoma City
country: United States
facility: Health Research of Oklahoma
state: Oklahoma
city: Oklahoma City
country: United States
facility: Oklahoma Medical Research Foundation (OMRF)
state: Oklahoma
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Philadelphia
country: United States
facility: The Arthritis Group
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Arthritis and Autoimmunity Clinic
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Lupus Center of Excellence
state: Pennsylvania
city: Wyomissing
country: United States
facility: Clinical Research Center of Reading, LLC
state: Pennsylvania
city: Charleston
country: United States
facility: Rheumatology Associates, P.A.
state: South Carolina
city: Greenville
country: United States
facility: Innovative Clinical Research, LLC
state: South Carolina
city: Greenville
country: United States
facility: Piedmont Arthritis Clinic, PA
state: South Carolina
city: Orangeburg
country: United States
facility: Articluaris Healthcare Group d/b/a ACME Research
state: South Carolina
city: Summerville
country: United States
facility: Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology
state: South Carolina
city: Jackson
country: United States
facility: West Tennessee Research Institute
state: Tennessee
city: Knoxville
country: United States
facility: Rheumatology Consultants, PLLC
state: Tennessee
city: Memphis
country: United States
facility: Dr. Ramesh C. Gupta MD, Office of
state: Tennessee
city: Nashville
country: United States
facility: Center For Inflammatory Disease
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: Carrollton
country: United States
facility: Trinity Universal Research Associates, Inc
state: Texas
city: Cypress
country: United States
facility: Pioneer Research Solutions, Inc.
state: Texas
city: Dallas
country: United States
facility: Baylor Scott and White Research Institute / Arthritis Care and Research Center
state: Texas
city: Dallas
country: United States
facility: Arthritis Centers of Texas
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Accurate Clinical Management, LLC
state: Texas
city: Houston
country: United States
facility: Rheumatic Disease Clinical Research Center
state: Texas
city: Houston
country: United States
facility: Accurate Clinical Research, Inc.
state: Texas
city: Houston
country: United States
facility: Houston Institute for Clinical Research
state: Texas
city: Houston
country: United States
facility: Accurate Clinical Management, LLC
state: Texas
city: Houston
country: United States
facility: Medical Center Research, LLC
state: Texas
city: League City
country: United States
facility: Accurate Clinical Research, Inc.
state: Texas
city: Lubbock
country: United States
facility: Arthritis and Osteoporosis Associates, LLP
state: Texas
city: Mesquite
country: United States
facility: Southwest Rheumatology Research, LLC
state: Texas
city: Plano
country: United States
facility: Trinity Universal Research Associates, Inc.
state: Texas
city: Chesapeake
country: United States
facility: Center for Arthritis and Rheumatic Diseases, PC
state: Virginia
city: Suffolk
country: United States
facility: Center for Arthritis and Rheumatic Diseases, P.C.
state: Virginia
city: Glendale
country: United States
facility: Rheumatic Disease Center
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: OMI- Organizacion Medica de Investigacion
state: Caba
city: C.a.b.a.
country: Argentina
facility: Centro de Educacion Medica e Investigaciones Clinicas Norberto Quirno (CEMIC)
state: Caba
city: Rosario
country: Argentina
facility: Sanatorio Parque S.A y Consultorios Externos Asociados
state: Santa FE
city: San Miguel de Tucuman
country: Argentina
facility: Centro Medico Privado de Reumatologia
state: Tucuman
city: Buenos Aires
country: Argentina
facility: Consultorios Reumatologicos Pampa.
city: Caba
country: Argentina
facility: CIER - Centro de Investigaciones en Enfermedades Reumaticas
city: Caba
country: Argentina
facility: Centro Privado de Medicina Familiar - Mindout Research S.R.L.
city: Cordoba
country: Argentina
facility: Hospital Privado Centro Medico de Cordoba S.A.
city: Rosario
country: Argentina
facility: Sanatorio Parque S.A y Consultorios Externos Asociados
city: San Isidro
country: Argentina
facility: I.A.R.I. Instituto de Asistencia Reumatologica Integral - Sede IMAC
city: San Juan
country: Argentina
facility: CER San Juan
city: Woodville South
country: Australia
facility: The Queen Elizabeth Hospital
state: South Australia
city: Fitzroy
country: Australia
facility: St. Vincent's Hospital (Melbourne)
state: Victoria
city: Heidelberg West
country: Australia
facility: Austin Health - Repatriation Hospital
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Repatriation Hospital
state: Victoria
city: Victoria Park
country: Australia
facility: RK Will Pty Ltd
state: Western Australia
city: Salvador
country: Brazil
facility: SER - Servicos Especializados em Reumatologia da Bahia
state: BA
city: Vitoria
country: Brazil
facility: CEDOES - Centro de Diagnostico e Pesquisa da Osteoporose do Espirito Santo
state: Espírito Santo
city: Juiz De Fora
country: Brazil
facility: CMIP- Centro Mineiro de Pesquisa Ltda/CETAL- Centro de Estudos e Tratamento do Aparelho Locomotor
state: MG
city: Belo Horizonte
country: Brazil
facility: Hospital das Clinicas Universidade Federal de Minas Gerais
state: Minas Gerais
city: Curitiba
country: Brazil
facility: EDUMED - Educacao em Saude SS Ltda
state: PR
city: Rio de Janeiro
country: Brazil
facility: CCBR Brasil - Centro de Pesquisas e Analises Clinicas LTDA
state: RJ
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre - UFRGS
state: RS
city: São Jose do Rio Preto
country: Brazil
facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
state: SAO Paulo
city: Campinas
country: Brazil
facility: Clinica Medica Bonfliglioli Ltda.
state: SP
city: Sao Paulo
country: Brazil
facility: CPCLin - Centro de Pesquisas Clinicas Ltda. / Clinica Dr. Freddy Goldberg Eliaschewitz LTDA EPP
state: SP
city: Sao Paulo
country: Brazil
facility: AACD- Lar Escola\ Associacao de Assistencia a Crianca Deficiente
state: SP
city: Sao Paulo
country: Brazil
facility: Instituto de Assistencia Medica do Hospital do Servidor Publico Estadual
state: SP
city: Sao Paulo
country: Brazil
facility: Fundacao Faculdade de Medicina MECMPAS - Hospital das Clinicas da FMUSP
state: SP
city: Sao Paulo
country: Brazil
facility: Hospital Israelita Albert Einstein
state: SP
city: Rio Grande De Sul
country: Brazil
facility: Hospital Moinhos de Vento
city: Sao Paulo
country: Brazil
facility: CEPIC - Centro Paulista de Investigacao Clinica e Servicos Medicos Ltda
city: Pleven
country: Bulgaria
facility: UMBAL "Dr Georgi Stranski" EAD
city: Plovdiv
country: Bulgaria
facility: MBAL Eurohospital Plovdiv OOD
city: Ruse
country: Bulgaria
facility: MBAL RUSe AD,
city: Sofia
country: Bulgaria
facility: UMBAL Sveti Ivan Rilski" EAD
city: Varna
country: Bulgaria
facility: MBAL Sveta Marina EAD
city: Edmonton
country: Canada
facility: Rheumatology Research Associates
state: Alberta
city: Victoria
country: Canada
facility: PerCuro Clinical Research Limited
state: British Columbia
city: Ottawa
country: Canada
facility: Medicine Professional Corporation
state: Ontario
city: Windsor
country: Canada
facility: Clinical Research and Arthritis Centre
state: Ontario
city: Rimouski
country: Canada
facility: Centre de Rhumatologie de l'Est du Quebec
state: Quebec
city: Trois-Rivieres
country: Canada
facility: Centre de Recherche Musculo-Squelettique
state: Quebec
city: Santiago
country: Chile
facility: Prosalud
state: Metropolitana
city: Temuco
country: Chile
facility: Centro Medico de Reumatologia Ltda.
state: Region DE LA Araucania
city: Santiago
country: Chile
facility: Centro de Investigacion Clinica Universidad Catolica (CICUC)
state: Region Metropolitana
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
city: Medellin
country: Colombia
facility: Centro Integral de Reumatologia REUMALAB S.A.S.
state: Antioquia
city: Bogota D.C.
country: Colombia
facility: Centro de Investigacion en Reumatologia y Especialidades Medicas S.A.S, CIREEM S.A.S
state: Cundinamarca
city: Bogota
country: Colombia
facility: Centro de Investigaciones Clinica del Country
state: Cundinamarca
city: Chia
country: Colombia
facility: Preventive Care S.A.S.
state: Cundinamarca
city: Bucaramanga
country: Colombia
facility: Servimed S.A.S
state: Santander
city: Ostrava
country: Czechia
facility: Vesalion, s.r.o.
state: Czech Republic
city: Praha 11
country: Czechia
facility: Mediscan Group, s.r.o.
state: Czech Republic
city: Brno - Zidenice
country: Czechia
facility: Revmacentrum MUDr. Mostera, s.r.o.
city: Brno
country: Czechia
facility: REVMACLINIC s.r.o.
city: Brno
country: Czechia
facility: Revmatologie, s.r.o.
city: Ostrava
country: Czechia
facility: Artroscan, s.r.o.
city: Praha 2
country: Czechia
facility: Revmatologicky ustav.
city: Praha 4
country: Czechia
facility: Revmatologicka Ambulance
city: Zlin
country: Czechia
facility: PV - MEDICAL s.r.o.
city: Helsinki
country: Finland
facility: Helsingin yliopistollinen keskussairaala
city: Hyvinkaa
country: Finland
facility: Kiljavan Laaketutkimus Oy
city: Hyvinkaa
country: Finland
facility: Laakarikeskus Aava Hyvinkaan Pipetti
city: Chai Wan
country: Hong Kong
facility: Pamela Youde Nethersole Eastern Hospital
state: HKG
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong (HKU)-Queen Mary Hospital (QMH)
city: Hong Kong
country: Hong Kong
facility: Tuen Mun Hospital
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital
city: Ashkelon
country: Israel
facility: Barzilai Medical Center - Rheumatology Outpatient Clinic
city: Beer Yaacov
country: Israel
facility: Assaf Harofeh Medical Center
city: Haifa
country: Israel
facility: Bnai Zion Medical Center Rheumatology Unit
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Haifa
country: Israel
facility: Carmel Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Center - Hebrew University Hospital
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Tel-Hashomer
country: Israel
facility: The Chaim Sheba Medical Center
city: Amman
country: Jordan
facility: Istishari Hospital
city: Irbid
country: Jordan
facility: King Abdullah University Hospital
city: Achrafieh
country: Lebanon
facility: Hotel Dieu de France Hospital
state: Beirut
city: Lebanon
country: Lebanon
facility: Ain Wazein Hospital
city: Ipoh
country: Malaysia
facility: Hospital Raja Permaisuri Bainun
state: Perak
city: Kuching
country: Malaysia
facility: Sarawak General Hospital
state: Sarawak
city: Batu Caves
country: Malaysia
facility: Hospital Selayang, Department of Medicine
state: Selangor
city: Torreon
country: Mexico
facility: Unidad de Enfermedades Reumaticas y Cronico Degenerativas S. C.
state: Coahuila
city: Mexico
country: Mexico
facility: Consultorio de Reumatologia
state: Distrito Federal
city: Mexico
country: Mexico
facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Centro Integral en Reumatologia SA de CV
state: Jalisco
city: Guadalajara
country: Mexico
facility: Hospital Civil de Guadalajara Fray Antonio Alcalde
state: Jalisco
city: Morelia
country: Mexico
facility: Centro de Investigacion Clinica de Morelia. S.C
state: Michoacan
city: Morelia
country: Mexico
facility: Clinica de Enfermedades Cronicas y Procedimientos Especiales, SC
state: Michoacan
city: Culiacan
country: Mexico
facility: Centro de Investigacion de Tratamientos Innovadores de Sinaloa, S.C
state: Sinaloa
city: Merida
country: Mexico
facility: Unidad Reumatologica Las Americas S.C.P.
state: Yucatan
city: Chihuahua
country: Mexico
facility: Investigacion y Biomedicina de Chihuahua SC
city: Ciudad de Mexico
country: Mexico
facility: CINTRE, Centro de Investigacion y Tratamiento Reumatologico S.C.
city: San Luis Potosi
country: Mexico
facility: Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi, S.C.
city: San Luis Potosi
country: Mexico
facility: Unidad de Investigaciones Reumatologicas
city: Leeuwarden
country: Netherlands
facility: Medical Center Leeuwarden
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum (UMC) Utrecht
city: Auckland
country: New Zealand
facility: Middlemore Hospital Middlemore Clinical Trials Trust
city: Hamilton
country: New Zealand
facility: Rheumatology Clinic, Waikato Hospital
city: Timaru
country: New Zealand
facility: Timaru Hospital
city: Wellington
country: New Zealand
facility: Wellington Hospital
city: Trujillo
country: Peru
facility: Centro de Investigacion Clinica Trujillo E.I.R.L. Clinica Peruana Americana
state: LA Libertad
city: Arequipa
country: Peru
facility: Centro de lnvestigacion de la Red Asistencial del Hospital Nacional ESSALUD Carlos Alberto Seguin E.
city: Lima
country: Peru
facility: ACQ MEDIC S.A.C. - Centro de Investigacion Clinica Inmunoreumatologia
city: Lima
country: Peru
facility: Unidad de Investigacion de la Clinica Internacional - Clinica Internacional
city: Lima
country: Peru
facility: ABK REUMA S.R.L. de Medicentro Biociencias- BIO CIENCIAS PERU S.R.L.
city: Lima
country: Peru
facility: Instituto Peruano del Hueso y la Articulacion - Instituto Peruano del Hueso y la Articulacion S.A.C.
city: Lima
country: Peru
facility: Investigaciones en Reumatologia - Centro Medico Corpac
city: Lima
country: Peru
facility: Investigaciones Clinicas S.A.C.
city: Lima
country: Peru
facility: Centro de Investigacion de Reumatologia - Clinica San Borja
city: Lima
country: Peru
facility: Centro de Investigacion en Salud - Centro de Excelencia en Reumatologia
city: Nadarzyn
country: Poland
facility: NZOZ Lecznica MAK-MED
state: Mazowieckie
city: Bialystok
country: Poland
facility: Zdrowie Osteo-Medic s.c. Lidia i Artur Racewicz, Agnieszka i Jerzy Supronik
state: Podlaskie
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy
city: Elblag
country: Poland
facility: Centrum Kliniczno-Badawcze J.Brzezicki, B.Gornikiewicz-Brzezicka Lekarze Spolka Partnerska
city: Gdynia
country: Poland
facility: Centrum Medyczne Pratia Gdynia
city: Gdynia
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Gdyni
city: Katowice
country: Poland
facility: Centrum Medyczne Pratia Katowice
city: Lublin
country: Poland
facility: Indywidualna Praktyka lekarska Dr hab. med. Anna Szczepańska - Szerej
city: Lublin
country: Poland
facility: Zespol Poradni Specjalistycznych Reumed Filia Onyksowa
city: Olsztyn
country: Poland
facility: PROFMEDICUS Sp. z o.o., Osrodek Badan Klinicznych
city: Poznan
country: Poland
facility: Prywatna Praktyka Lekarska Prof. UM dr hab. med. Pawel Hrycaj
city: Sopot
country: Poland
facility: Pomorskie Centrum Reumatologiczne im. Dr Jadwigi Titz-Kosko w Sopocie, Spolka. z o.o.
city: Staszow
country: Poland
facility: KO-MED Centra Kliniczne Sp. zo.o.
city: Torun
country: Poland
facility: NASZ LEKARZ Przychodnie Medyczne
city: Warsaw
country: Poland
facility: Rheuma Medicus Zaklad Opieki Zdrowotnej
city: Warszawa
country: Poland
facility: Centrum Medyczne Pratia Warszawa
city: Wroclaw
country: Poland
facility: Synexus Polska Sp. z o.o.
city: Wroclaw
country: Poland
facility: NZOZ Biogenes Sp. z o.o.
city: Ponce
country: Puerto Rico
facility: Ponce Medical School Foundation, Inc.
city: San Juan
country: Puerto Rico
facility: Fundacion de Investigaction de Diego
city: St. Petersburg
country: Russian Federation
facility: Saint-Petersburg State Budgetary Institution of Healthcare Municipal hospital # 40 of the
state: St.petersburg
city: Moscow
country: Russian Federation
facility: SBHI City Clinical Hospital #4 of HD of Moscow
city: Moscow
country: Russian Federation
facility: SBHI of Moscow City Clinical Hospital 1 n. a. N.I. Pirogov of the Healthcare Department of Moscow
city: Nizhniy Novgorod
country: Russian Federation
facility: SBIH of Nizhniy Novgorod region City Clinical Hospital #5 of Nizhniy Novgorod district
city: Novosibirsk
country: Russian Federation
facility: Federal State Budgetary Scientific Institution "Research Institute of Fundamental and
city: Novosibirsk
country: Russian Federation
facility: Consulting and Diagnostic Rheumatological Center Healthy Joints LLC
city: Petrozavodsk
country: Russian Federation
facility: GBUZ RK Republic Hospital n. a. V.A. Baranov of the MoH & social development Of The Karelia Republic
city: Smolensk
country: Russian Federation
facility: Federal State Budgetary Educational Institution of Higher Education
city: St. Petersburg
country: Russian Federation
facility: Saint-Petersburg State Budget Healthcare Institution Consultative-diagnostic Center #85
city: Yekaterinburg
country: Russian Federation
facility: SBEI of HPE Ural State Medical University of the MoH of the RF
city: Yekaterinburg
country: Russian Federation
facility: Municipal Budgetary Institution "Central City Clinical Hospital #6"
city: Bratislava - Petrzalka
country: Slovakia
facility: ROMJAN s.r. o. , Specializovana Reumatologicka ambulancia
city: Bratislava
country: Slovakia
facility: Nestatna reumatologicka ambulancia
city: Dunajska Streda
country: Slovakia
facility: AAGS, s.r.o., Reumatologicka ambulancia
city: Nove Zamky
country: Slovakia
facility: ECCLESIA s.r.o, Reumatologicka ambulancia
city: Partizanske
country: Slovakia
facility: REUMACENTRUM s.r.o., Reumatologicka ambulancia
city: Rimavska Sobota
country: Slovakia
facility: Reumex s.r.o
city: Trnava
country: Slovakia
facility: Reuma-Global s.r.o., Reumatologicka ambulancia
city: Port Elizabeth
country: South Africa
facility: Greenacres Hospital
state: Eastern CAPE
city: Johannesburg
country: South Africa
facility: Wits Clinical Research Site
state: Gauteng
city: Kempton Park
country: South Africa
facility: Clinresco Centres ( Pty ) Ltd
state: Gauteng
city: Pretoria
country: South Africa
facility: Jakaranda Hospital
state: Gauteng
city: Pretoria
country: South Africa
facility: Emmed Research
state: Gauteng
city: Durban
country: South Africa
facility: St. Augustine's Hospital - Chelmsford Medical Centre 2
state: Kwa-zulu Natal
city: Bellville, Cape Town
country: South Africa
facility: Tiervlei Trial Centre, Karl Bremer Hospital
state: Western CAPE
city: Cape Town
country: South Africa
facility: Arthritis Clinical Research Trials cc
state: Western CAPE
city: Cape Town
country: South Africa
facility: Panorama Medical Centre
state: Western CAPE
city: Cape Town
country: South Africa
facility: University of Cape Town
state: Western CAPE
city: Stellenbosch
country: South Africa
facility: Winelands Medical Research Centre-
city: Merida
country: Spain
facility: Hospital de Merida
state: Badajoz
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
state: Cantabria
city: Santiago de Compostela
country: Spain
facility: Hospital Nuestra Senora de la Esperanza
state: LA Coruna
city: Barakaldo
country: Spain
facility: Hospital Universitario de Cruces
state: Vizcaya
city: Bilbao
country: Spain
facility: Hospital Universitario de Basurto
state: Vizcaya
city: Barcelona
country: Spain
facility: Hospital Plato
city: Barcelona
country: Spain
facility: Hospital De La Santa Creu I Sant Pau
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Malaga
country: Spain
facility: Hospital Regional Universitario de Malaga
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen de la Macarena
city: Taichung City
country: Taiwan
facility: China Medical University Hospital
state: Taiwan (r.o.c)
city: Changhua City
country: Taiwan
facility: Changhua Christian Hospital
city: Chia-Yi
country: Taiwan
facility: Buddhist Dalin Tzu Chi General Hospital
city: Taichung City
country: Taiwan
facility: Chung Shan Medical University Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan City
country: Taiwan
facility: Chang Gung Medical Foundation - Linkou Branch
city: Bangkok
country: Thailand
facility: Phramongkutklao Hospital
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital, Mahidol University
city: Bangkok
country: Thailand
facility: Faculty of Medicine , Siriraj Hospital , Mahidol University
city: Chiang Mai
country: Thailand
facility: Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine,Chiang Mai University
city: Songkhla
country: Thailand
facility: Prince of Songkla University
city: Ankara
country: Turkey
facility: Ankara Universitesi Tip Fakultesi Ibn-i Sina Hastanesi
city: Ankara
country: Turkey
facility: Hacettepe Universitesi Tip Fakultesi
city: Aydin
country: Turkey
facility: Adnan Menderes Universitesi Tip Fakultesi Hastanesi
city: Gaziantep
country: Turkey
facility: Gaziantep Universitesi Tip Fakultesi
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi
city: Izmir
country: Turkey
facility: Izmir Tepecik Egitim ve Arastirma Hastanesi
city: Kocaeli
country: Turkey
facility: Kocaeli Universitesi Tip Fakultesi Hastanesi
city: Samsun
country: Turkey
facility: Ondokuz Mayis Universitesi Tip Fakultesi Fiziksel Tip ve
city: Sivas
country: Turkey
facility: Cumhuriyet Universitesi Tip Fakultesi Hastanesi
city: Poole
country: United Kingdom
facility: Poole Hospital, University Hospitals Dorset NHS Foundation Trust
state: Dorset
city: Goodmayes
country: United Kingdom
facility: Barking, Havering and Redbridge University Hospitals NHS Trust
state: Essex
city: Cannock
country: United Kingdom
facility: The Royal Wolverhampton NHS Trust-Cannock Chase Hospital
city: Liverpool
country: United Kingdom
facility: Aintree University Hospital, Liverpool University Hospitals
city: Liverpool
country: United Kingdom
facility: Clinical trials, Pharmacy Department, Aintree University Hospitals
city: Liverpool
country: United Kingdom
facility: University of Liverpool Academic Rheumatology Unit. Aintree University Hospital. Liverpool Universit
city: Newcastle Upon Tyne
country: United Kingdom
facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust, Clinical Research Facility
city: North Shields
country: United Kingdom
facility: Northumbria Healthcare NHS Foundation Trust
city: Wolverhampton
country: United Kingdom
facility: Pharmacy Department
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Weitz JI, Szekanecz Z, Charles-Schoeman C, Vranic I, Sahin B, Paciga SA, Wang Z, Hyde C, Martin DA. Biomarkers to predict risk of venous thromboembolism in patients with rheumatoid arthritis receiving tofacitinib or tumour necrosis factor inhibitors. RMD Open. 2022 Nov;8(2):e002571. doi: 10.1136/rmdopen-2022-002571.
citation: Charles-Schoeman C, Buch MH, Dougados M, Bhatt DL, Giles JT, Ytterberg SR, Koch GG, Vranic I, Wu J, Wang C, Kwok K, Menon S, Rivas JL, Yndestad A, Connell CA, Szekanecz Z. Risk of major adverse cardiovascular events with tofacitinib versus tumour necrosis factor inhibitors in patients with rheumatoid arthritis with or without a history of atherosclerotic cardiovascular disease: a post hoc analysis from ORAL Surveillance. Ann Rheum Dis. 2023 Jan;82(1):119-129. doi: 10.1136/ard-2022-222259. Epub 2022 Sep 22.
citation: Balanescu AR, Citera G, Pascual-Ramos V, Bhatt DL, Connell CA, Gold D, Chen AS, Sawyerr G, Shapiro AB, Pope JE, Schulze-Koops H. Infections in patients with rheumatoid arthritis receiving tofacitinib versus tumour necrosis factor inhibitors: results from the open-label, randomised controlled ORAL Surveillance trial. Ann Rheum Dis. 2022 Nov;81(11):1491-1503. doi: 10.1136/ard-2022-222405. Epub 2022 Aug 3.
citation: Ytterberg SR, Bhatt DL, Mikuls TR, Koch GG, Fleischmann R, Rivas JL, Germino R, Menon S, Sun Y, Wang C, Shapiro AB, Kanik KS, Connell CA; ORAL Surveillance Investigators. Cardiovascular and Cancer Risk with Tofacitinib in Rheumatoid Arthritis. N Engl J Med. 2022 Jan 27;386(4):316-326. doi: 10.1056/NEJMoa2109927.