Safety Study Of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid Arthritis
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
2 other identifiers
interventional
4,372
30 countries
345
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2014
Longer than P75 for phase_4
345 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 3, 2014
CompletedStudy Start
First participant enrolled
March 14, 2014
CompletedFirst Posted
Study publicly available on registry
March 20, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 22, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 22, 2020
CompletedResults Posted
Study results publicly available
August 17, 2021
CompletedAugust 17, 2021
July 1, 2021
6.4 years
March 3, 2014
July 21, 2021
July 21, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence Rate of Adjudicated Malignancies Excluding Non-melanoma Skin Cancers (NMSC)
Incidence rate (number of participants with event per 100 participant year \[PY\]) was defined as the total number of participants with admissible events divided by the total (for all qualifying participants) time at risk for the cohort/treatment group of interest. Malignancy events, excluding NMSC were adjudicated by a steering committee. The risk period (RP) was the last contact date. The last contact date was the maximum of (AE start date, AE stop date, last study visit date, withdrawal date, telephone contact date). If a participant died, last contact date was the death date. First events were counted within the RP. If a participant did not have an event or had an event but outside the risk period, the participant was censored at the end of RP.
Baseline up to last contact date (maximum up to 72 months)
Incidence Rate of Adjudicated Major Adverse Cardiovascular Events (MACE)
MACE included the cardiovascular death, non-fatal myocardial infarction (MI) and non-fatal stroke of any classification, including reversible focal neurologic defects with imaging evidence of a new cerebral lesion consistent with ischemia or hemorrhage. Incidence rate was defined as the total number of participants with admissible events divided by the total (for all qualifying participants) time at risk for the cohort/treatment group of interest. The risk period (RP) was the minimum of last contact date or last study treatment dose date + 60 days. The last contact date was the maximum of (AE start date, AE stop date, last study visit date, withdrawal date, telephone contact date). If a participant died, last contact date was the death date. First events were counted within the RP. If a participant did not have an event or had an event but outside the risk period, the participant was censored at the end of RP.
Baseline up to last contact date (maximum up to 72 months)
Secondary Outcomes (22)
Incidence Rate of Non-fatal Stroke
Baseline up to last contact date (maximum up to 72 months)
Incidence Rate of Non-fatal Myocardial Infarction
Baseline up to last contact date (maximum up to 72 months)
Incidence Rate of Adjudicated Opportunistic Infection Events Including Tuberculosis
Baseline up to last contact date (maximum up to 72 months)
Incidence Rate of Adjudicated Hepatic Events
Baseline up to last contact date (maximum up to 72 months)
Incidence Rate of Adjudicated Cardiovascular Events Other Than Major Adverse Cardiovascular Events (MACE)
Baseline up to last contact date (maximum up to 72 months)
- +17 more secondary outcomes
Study Arms (3)
Treatment Arm 1
EXPERIMENTALTreatment Arm 2
EXPERIMENTALTreatment Arm 3
ACTIVE COMPARATORTNF inhibitor Arm - adalimumab will be used in US, Canada and Puerto Rico; etanercept will be used in all other countries.
Interventions
Pre-filled syringe, 40 mg subcutaneous injection, every other week
Pre-filled syringe, 50 mg subcutaneous injection, every week
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Current or recent infection
- Clinically significant laboratory abnormalities
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (345)
University of Alabama at Birmingham (UAB), Arthritis Clinical Intervention Program
Birmingham, Alabama, 35294-7201, United States
Rheumatology Associates of North Alabama, PC
Huntsville, Alabama, 35801, United States
Clinical and Translational Research Center of Alabama, PC
Tuscaloosa, Alabama, 35406, United States
Southern Arizona VA Health Care System (SAVAHCS)
Tucson, Arizona, 85723, United States
University of Arizona Clinical and Translational Science Research Center
Tucson, Arizona, 85724, United States
CHI St. Vincent Medical Group Hot Springs
Hot Springs, Arkansas, 71913, United States
Arthritis And Rheumatism Associates LLC
Jonesboro, Arkansas, 72401, United States
Medvin Clinical Research
Covina, California, 91722, United States
Med Investigations, Inc.
Fair Oaks, California, 95628, United States
Talbert Medical Group
Huntington Beach, California, 92646, United States
University of California, San Diego (UCSD)- Perlman Ambulatory Clinic
La Jolla, California, 92037, United States
Valerius Medical Group And Research Center Of Greater Long Beach, Inc.
Long Beach, California, 90806, United States
ProHealth Partners
Long Beach, California, 90808, United States
Keck Medicine of USC
Los Angeles, California, 90033, United States
California Medical Research Associates Inc
Northridge, California, 91324, United States
Desert Medical Advances
Palm Desert, California, 92260, United States
Medvin Clinical Research
Placentia, California, 92870, United States
Sierra Rheumatology, Inc.
Roseville, California, 95661, United States
San Diego Arthritis Medical Clinic
San Diego, California, 92108, United States
Dr. Orrin M. Troum, Md And Medical Associates
Santa Monica, California, 90404, United States
Los Angeles Biomedical Research Institute at Harbor UCLA Medical Center
Torrance, California, 90502, United States
Harbor UCLA Medical Center
Torrance, California, 90509, United States
Robin K. Dore M.D., Inc.
Tustin, California, 92780, United States
Medvin Clinical Research
Van Nuys, California, 91405, United States
Ventura Clinical Trials
Ventura, California, 93003, United States
Desert Valley Medical Group
Victorville, California, 92395, United States
Medvin Clinical Research
Whittier, California, 90602, United States
Arthritis Associates and Osteoporosis Center of Colorado Springs
Colorado Springs, Colorado, 80920, United States
Howard University Hospital
Washington D.C., District of Columbia, 20060, United States
RASF-Clinical Research Center, Inc
Boca Raton, Florida, 33486, United States
Bay Area Arthritis and Osteoporosis
Brandon, Florida, 33511, United States
Arthritis & Rheumatism Associates (Private Practice)
Clearwater, Florida, 33756, United States
Florida Clinical Research Group (Administrative Office)
Clearwater, Florida, 33759, United States
Dr.Robert W. Levin MDOffice of
Clearwater, Florida, 33765, United States
International Medical Research
Daytona Beach, Florida, 32117, United States
Centre for Rheumatology, Immunology and Arthritis
Fort Lauderdale, Florida, 33309, United States
University of Florida - Rheumatology at ACC
Jacksonville, Florida, 32207, United States
University of Florida College of Medicine, Jacksonville - Rheumatology Research
Jacksonville, Florida, 32207, United States
Doctors Research Institute
Miami, Florida, 33145, United States
Center for Arthritis and Rheumatic Diseases
Miami, Florida, 33173, United States
San Marcus Research Clinic
Miami Lakes, Florida, 33014, United States
Ocala Rheumatology Research Center
Ocala, Florida, 34474, United States
Advanced Clinical Research of Orlando
Ocoee, Florida, 34761, United States
Arthritis & osteoporosis treatment center,PA
Orange Park, Florida, 32073, United States
Rheumatology Associates of Central Florida, PA
Orlando, Florida, 32806, United States
Omega Research Consultants, LLC
Orlando, Florida, 32810, United States
Millennium Research
Ormond Beach, Florida, 32174, United States
Arthritis Center, Inc.
Palm Harbor, Florida, 34684, United States
Arthritis Research of Florida, Inc.
Palm Harbor, Florida, 34684, United States
Advanced Medical Research Center
Port Orange, Florida, 32127, United States
Advanced Urgent Care
Port Orange, Florida, 32127, United States
USF Health Morsani Center for Advanced Healthcare
Tampa, Florida, 33612, United States
Florida Medical Clinic, P.A.
Zephyrhills, Florida, 33542, United States
Arthritis and Rheumatology of GA, P.C.
Atlanta, Georgia, 30342, United States
Medical Associates of North Georgia - Rheumatology
Canton, Georgia, 30115, United States
Office of Jefrey D. Lieberman, MD, PC
Decatur, Georgia, 30033, United States
Coeur D'Alene Arthritis Clinic
Coeur d'Alene, Idaho, 83814, United States
Quincy Medical Group
Quincy, Illinois, 62301, United States
Springfield Clinic
Springfield, Illinois, 62702, United States
Diagnostic Rheumatology and Research PC
Indianapolis, Indiana, 46227, United States
MidWest Clinical Research, LLC
Overland Park, Kansas, 66209, United States
Professional Research Network of Kansas, LLC
Wichita, Kansas, 67205-1138, United States
Arthritis and Diabetes Clinic, Inc.
Monroe, Louisiana, 71203, United States
Klein & Associates, M.D.,P.A.
Cumberland, Maryland, 21502, United States
Arthritis Treatment Center
Frederick, Maryland, 21702, United States
Klein & Associates, MD, PA
Hagerstown, Maryland, 21740, United States
The Center for Rheumatology and Bone Research, a division of Arthritis and Rheumatism Associates, PC
Wheaton, Maryland, 20902, United States
Phase III Clinical Research
Fall River, Massachusetts, 02720, United States
UMass Memorial Medical Center, Memorial Campus
Worcester, Massachusetts, 01605, United States
Bronson Healthcare Group
Battle Creek, Michigan, 49015, United States
Bronson Rheumatology Specialists
Kalamazoo, Michigan, 49007, United States
Jasper Clinic, Inc.
Kalamazoo, Michigan, 49007, United States
Western Michigan University Homer Stryker M.D. School of Medicine Center for Clinical Research
Kalamazoo, Michigan, 49008, United States
Borgess Medical Center
Kalamazoo, Michigan, 49048, United States
Borgess Research Institute
Kalamazoo, Michigan, 49048, United States
June DO,PC
Lansing, Michigan, 48910, United States
Shores Rheumatology P.C.
Saint Clair Shores, Michigan, 48081, United States
St. Paul Rheumatology, PA
Eagan, Minnesota, 55121, United States
Center for Diagnostic Imaging
Mendota Heights, Minnesota, 55118, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Kansas City Internal Medicine
Kansas City, Missouri, 64114, United States
Clinvest Research, LLC
Springfield, Missouri, 65810, United States
Glacier View Research Institute
Kalispell, Montana, 59901, United States
Physician Research Collaboration, LLC
Lincoln, Nebraska, 68516, United States
Westroads Clinical Research, Inc.
Omaha, Nebraska, 68114, United States
University of Nevada School of Medicine
Las Vegas, Nevada, 89102, United States
Steinberg Diagnostics
Las Vegas, Nevada, 89109, United States
EKSAKTI, LLC (dba: Eksakti Clinical Research)
Las Vegas, Nevada, 89128, United States
Arthritis Center Of Reno
Reno, Nevada, 89502, United States
Nashua Rheumatology
Nashua, New Hampshire, 03060, United States
Summit Medical Group
Clifton, New Jersey, 07012, United States
Weill Cornell Physicians at Brooklyn Heights
Brooklyn, New York, 11201, United States
Northwell Health Division of Rheumatology
Great Neck, New York, 11021, United States
NYU Langone Rheumatology Associates Long Island.
Lake Success, New York, 11042, United States
EmergeOrtho,P.A.
Durham, North Carolina, 27704, United States
Physicians East, PA
Greenville, North Carolina, 27834, United States
PMG Research of Hickory LLC
Hickory, North Carolina, 28601, United States
Frycare outpatient imaging Center
Hickory, North Carolina, 28602, United States
PMG Research of Hickory, LLC
Hickory, North Carolina, 28602, United States
PMG Research Inc., d/b/a PMG Research of Piedmont HealthCare
Statesville, North Carolina, 28625, United States
Carolina Arthritis Associates
Wilmington, North Carolina, 28401, United States
St. Alexius Medical Center
Bismarck, North Dakota, 58501, United States
Trinity Health Center - Medical Arts
Minot, North Dakota, 58701, United States
Cincinnati Rheumatic Disease Study Group, Inc.
Cincinnati, Ohio, 45242, United States
STAT Research, Inc.
Dayton, Ohio, 45417, United States
Health Research of Oklahoma
Oklahoma City, Oklahoma, 73103, United States
Oklahoma Medical Research Foundation (OMRF)
Oklahoma City, Oklahoma, 73104, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
The Arthritis Group
Philadelphia, Pennsylvania, 19152, United States
UPMC Arthritis and Autoimmunity Clinic
Pittsburgh, Pennsylvania, 15213, United States
UPMC Lupus Center of Excellence
Pittsburgh, Pennsylvania, 15213, United States
Clinical Research Center of Reading, LLC
Wyomissing, Pennsylvania, 19610, United States
Rheumatology Associates, P.A.
Charleston, South Carolina, 29407, United States
Innovative Clinical Research, LLC
Greenville, South Carolina, 29601, United States
Piedmont Arthritis Clinic, PA
Greenville, South Carolina, 29601, United States
Articluaris Healthcare Group d/b/a ACME Research
Orangeburg, South Carolina, 29118, United States
Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology
Summerville, South Carolina, 29486, United States
West Tennessee Research Institute
Jackson, Tennessee, 38305, United States
Rheumatology Consultants, PLLC
Knoxville, Tennessee, 37909, United States
Dr. Ramesh C. Gupta MD, Office of
Memphis, Tennessee, 38119, United States
Center For Inflammatory Disease
Nashville, Tennessee, 37203, United States
Amarillo Center for Clinical Research, Ltd.
Amarillo, Texas, 79124, United States
Austin Regional Clinic
Austin, Texas, 78731, United States
Trinity Universal Research Associates, Inc
Carrollton, Texas, 75007, United States
Pioneer Research Solutions, Inc.
Cypress, Texas, 77429, United States
Baylor Scott and White Research Institute / Arthritis Care and Research Center
Dallas, Texas, 75231, United States
Arthritis Centers of Texas
Dallas, Texas, 75246, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Accurate Clinical Management, LLC
Houston, Texas, 77004, United States
Rheumatic Disease Clinical Research Center
Houston, Texas, 77004, United States
Accurate Clinical Research, Inc.
Houston, Texas, 77034, United States
Houston Institute for Clinical Research
Houston, Texas, 77074, United States
Accurate Clinical Management, LLC
Houston, Texas, 77084, United States
Medical Center Research, LLC
Houston, Texas, 77089, United States
Accurate Clinical Research, Inc.
League City, Texas, 77573, United States
Arthritis and Osteoporosis Associates, LLP
Lubbock, Texas, 79424, United States
Southwest Rheumatology Research, LLC
Mesquite, Texas, 75150, United States
Trinity Universal Research Associates, Inc.
Plano, Texas, 75024, United States
Center for Arthritis and Rheumatic Diseases, PC
Chesapeake, Virginia, 23320, United States
Center for Arthritis and Rheumatic Diseases, P.C.
Suffolk, Virginia, 23435, United States
Rheumatic Disease Center
Glendale, Wisconsin, 53217, United States
OMI- Organizacion Medica de Investigacion
Buenos Aires, Buenos Aires F.D., C1015ABO, Argentina
Centro de Educacion Medica e Investigaciones Clinicas Norberto Quirno (CEMIC)
C.a.b.a., Buenos Aires F.D., 1431, Argentina
Sanatorio Parque S.A y Consultorios Externos Asociados
Rosario, Santa Fe Province, 2000, Argentina
Centro Medico Privado de Reumatologia
San Miguel de Tucumán, Tucumán Province, 4000, Argentina
Consultorios Reumatologicos Pampa.
Buenos Aires, 1428, Argentina
CIER - Centro de Investigaciones en Enfermedades Reumaticas
CABA, C1055AAF, Argentina
Centro Privado de Medicina Familiar - Mindout Research S.R.L.
CABA, C1417EYG, Argentina
Hospital Privado Centro Medico de Cordoba S.A.
Córdoba, 5016, Argentina
Sanatorio Parque S.A y Consultorios Externos Asociados
Rosario, 2000, Argentina
I.A.R.I. Instituto de Asistencia Reumatologica Integral - Sede IMAC
San Isidro, 1643, Argentina
CER San Juan
San Juan, 5400, Argentina
The Queen Elizabeth Hospital
Woodville South, South Australia, 5011, Australia
St. Vincent's Hospital (Melbourne)
Fitzroy, Victoria, 3065, Australia
Austin Repatriation Hospital
Heidelberg, Victoria, 3081, Australia
Austin Health - Repatriation Hospital
Heidelberg West, Victoria, 3081, Australia
RK Will Pty Ltd
Victoria Park, Western Australia, 6100, Australia
CEDOES - Centro de Diagnostico e Pesquisa da Osteoporose do Espirito Santo
Vitória, Espírito Santo, 29055-450, Brazil
SER - Servicos Especializados em Reumatologia da Bahia
Salvador, Estado de Bahia, 40150-150, Brazil
Hospital das Clinicas Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, 30130-100, Brazil
CMIP- Centro Mineiro de Pesquisa Ltda/CETAL- Centro de Estudos e Tratamento do Aparelho Locomotor
Juiz de Fora, Minas Gerais, 36010-570, Brazil
EDUMED - Educacao em Saude SS Ltda
Curitiba, Paraná, 80440-080, Brazil
CCBR Brasil - Centro de Pesquisas e Analises Clinicas LTDA
Rio de Janeiro, Rio de Janeiro, 22271-100, Brazil
Hospital de Clinicas de Porto Alegre - UFRGS
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Clinica Medica Bonfliglioli Ltda.
Campinas, São Paulo, 13015-001, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
São Jose Do Rio Preto, São Paulo, 15090-000, Brazil
CPCLin - Centro de Pesquisas Clinicas Ltda. / Clinica Dr. Freddy Goldberg Eliaschewitz LTDA EPP
São Paulo, São Paulo, 01244-030, Brazil
AACD- Lar Escola\ Associacao de Assistencia a Crianca Deficiente
São Paulo, São Paulo, 04032-060, Brazil
Instituto de Assistencia Medica do Hospital do Servidor Publico Estadual
São Paulo, São Paulo, 04039-901, Brazil
Fundacao Faculdade de Medicina MECMPAS - Hospital das Clinicas da FMUSP
São Paulo, São Paulo, 05403-900, Brazil
Hospital Israelita Albert Einstein
São Paulo, São Paulo, 05652-900, Brazil
Hospital Moinhos de Vento
Rio Grande de Sul, 90560-030, Brazil
CEPIC - Centro Paulista de Investigacao Clinica e Servicos Medicos Ltda
São Paulo, 04266-010, Brazil
UMBAL "Dr Georgi Stranski" EAD
Pleven, 5800, Bulgaria
MBAL Eurohospital Plovdiv OOD
Plovdiv, 4000, Bulgaria
MBAL RUSe AD,
Rousse, 7002, Bulgaria
UMBAL Sveti Ivan Rilski" EAD
Sofia, 1612, Bulgaria
MBAL Sveta Marina EAD
Varna, 9010, Bulgaria
Rheumatology Research Associates
Edmonton, Alberta, T5M 0H4, Canada
PerCuro Clinical Research Limited
Victoria, British Columbia, V8V 3M9, Canada
Medicine Professional Corporation
Ottawa, Ontario, K1Y 4G2, Canada
Clinical Research and Arthritis Centre
Windsor, Ontario, N8X2C9, Canada
Centre de Rhumatologie de l'Est du Quebec
Rimouski, Quebec, G5L 8W1, Canada
Centre de Recherche Musculo-Squelettique
Trois-Rivières, Quebec, G8Z 1Y2, Canada
Centro Medico de Reumatologia Ltda.
Temuco, Región de la Araucanía, 4790928, Chile
Prosalud
Santiago, Santiago Metropolitan, 7510047, Chile
Centro de Investigacion Clinica Universidad Catolica (CICUC)
Santiago, Santiago Metropolitan, 8330034, Chile
Guangdong General Hospital
Guangzhou, Guangdong, 510080, China
Centro Integral de Reumatologia REUMALAB S.A.S.
Medellín, Antioquia, Colombia
Centro de Investigacion en Reumatologia y Especialidades Medicas S.A.S, CIREEM S.A.S
Bogota D.C., Cundinamarca, 112201, Colombia
Centro de Investigaciones Clinica del Country
Bogota, Cundinamarca, Colombia
Preventive Care S.A.S.
Chía, Cundinamarca, 250001, Colombia
Servimed S.A.S
Bucaramanga, Santander Department, Colombia
Vesalion, s.r.o.
Ostrava, Czech Republic, 702 00, Czechia
Mediscan Group, s.r.o.
Prague, Czech Republic, 148 00, Czechia
REVMACLINIC s.r.o.
Brno, 61141, Czechia
Revmatologie, s.r.o.
Brno, 638 00, Czechia
Revmacentrum MUDr. Mostera, s.r.o.
Brno-Židenice, 615 00, Czechia
Artroscan, s.r.o.
Ostrava, 722 00, Czechia
Revmatologicky ustav.
Prague, 128 50, Czechia
Revmatologicka Ambulance
Prague, 140 00, Czechia
PV - MEDICAL s.r.o.
Zlín, 76001, Czechia
Helsingin yliopistollinen keskussairaala
Helsinki, 00290, Finland
Kiljavan Laaketutkimus Oy
Hyvinkää, 05800, Finland
Laakarikeskus Aava Hyvinkaan Pipetti
Hyvinkää, 05800, Finland
Pamela Youde Nethersole Eastern Hospital
Chai Wan, HKG, Hong Kong
The University of Hong Kong (HKU)-Queen Mary Hospital (QMH)
Hong Kong, 999077, Hong Kong
Tuen Mun Hospital
Hong Kong, Hong Kong
Prince of Wales Hospital
Shatin, Hong Kong
Barzilai Medical Center - Rheumatology Outpatient Clinic
Ashkelon, 78278, Israel
Assaf Harofeh Medical Center
Beer Yaacov, 70300, Israel
Bnai Zion Medical Center Rheumatology Unit
Haifa, 31048, Israel
Rambam Health Care Campus
Haifa, 3109601, Israel
Carmel Medical Center
Haifa, 34362, Israel
Hadassah Medical Center - Hebrew University Hospital
Jerusalem, 91120, Israel
Meir Medical Center
Kfar Saba, 44281, Israel
Rabin Medical Center
Petah Tikva, 49100, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239, Israel
The Chaim Sheba Medical Center
Tel Litwinsky, 52621, Israel
Istishari Hospital
Amman, 11184, Jordan
King Abdullah University Hospital
Irbid, 22110, Jordan
Hotel Dieu de France Hospital
El Achrafiyé, Beyrouth, Lebanon
Ain Wazein Hospital
Lebanon, Lebanon
Hospital Raja Permaisuri Bainun
Ipoh, Perak, 30990, Malaysia
Sarawak General Hospital
Kuching, Sarawak, 93586, Malaysia
Hospital Selayang, Department of Medicine
Batu Caves, Selangor, 68100, Malaysia
Unidad de Enfermedades Reumaticas y Cronico Degenerativas S. C.
Torreón, Coahuila, 27000, Mexico
Centro Integral en Reumatologia SA de CV
Guadalajara, Jalisco, 44160, Mexico
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, Jalisco, 44280, Mexico
Consultorio de Reumatologia
Mexico City, Mexico City, 07760, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, Mexico City, 14080, Mexico
Centro de Investigacion Clinica de Morelia. S.C
Morelia, Michoacán, 58070, Mexico
Clinica de Enfermedades Cronicas y Procedimientos Especiales, SC
Morelia, Michoacán, 58249, Mexico
Centro de Investigacion de Tratamientos Innovadores de Sinaloa, S.C
Culiacán, Sinaloa, 80000, Mexico
Unidad Reumatologica Las Americas S.C.P.
Mérida, Yucatán, 97000, Mexico
Investigacion y Biomedicina de Chihuahua SC
Chihuahua City, 31000, Mexico
CINTRE, Centro de Investigacion y Tratamiento Reumatologico S.C.
Mexico City, 11850, Mexico
Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi, S.C.
San Luis Potosí City, 78213, Mexico
Unidad de Investigaciones Reumatologicas
San Luis Potosí City, 78290, Mexico
Medical Center Leeuwarden
Leeuwarden, 8934 AD, Netherlands
Universitair Medisch Centrum (UMC) Utrecht
Utrecht, 3584 CX, Netherlands
Middlemore Hospital Middlemore Clinical Trials Trust
Auckland, 2025, New Zealand
Rheumatology Clinic, Waikato Hospital
Hamilton, 3204, New Zealand
Timaru Hospital
Timaru, 7910, New Zealand
Wellington Hospital
Wellington, 6021, New Zealand
Centro de Investigacion Clinica Trujillo E.I.R.L. Clinica Peruana Americana
Trujillo, La Libertad, 13001, Peru
Centro de lnvestigacion de la Red Asistencial del Hospital Nacional ESSALUD Carlos Alberto Seguin E.
Arequipa, 04001, Peru
ACQ MEDIC S.A.C. - Centro de Investigacion Clinica Inmunoreumatologia
Lima, 11, Peru
Unidad de Investigacion de la Clinica Internacional - Clinica Internacional
Lima, 1, Peru
ABK REUMA S.R.L. de Medicentro Biociencias- BIO CIENCIAS PERU S.R.L.
Lima, 21, Peru
Instituto Peruano del Hueso y la Articulacion - Instituto Peruano del Hueso y la Articulacion S.A.C.
Lima, 27, Peru
Investigaciones en Reumatologia - Centro Medico Corpac
Lima, 27, Peru
Investigaciones Clinicas S.A.C.
Lima, 33, Peru
Centro de Investigacion de Reumatologia - Clinica San Borja
Lima, 41, Peru
Centro de Investigacion en Salud - Centro de Excelencia en Reumatologia
Lima, 41, Peru
NZOZ Lecznica MAK-MED
Nadarzyn, Masovian Voivodeship, 05-830, Poland
Zdrowie Osteo-Medic s.c. Lidia i Artur Racewicz, Agnieszka i Jerzy Supronik
Bialystok, Podlaskie Voivodeship, 15-351, Poland
Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy
Bydgoszcz, 85-168, Poland
Centrum Kliniczno-Badawcze J.Brzezicki, B.Gornikiewicz-Brzezicka Lekarze Spolka Partnerska
Elblag, 82-300, Poland
Centrum Medyczne Pratia Gdynia
Gdynia, 81-338, Poland
Synexus Polska Sp. z o.o. Oddzial w Gdyni
Gdynia, 81-537, Poland
Centrum Medyczne Pratia Katowice
Katowice, 40-081, Poland
Indywidualna Praktyka lekarska Dr hab. med. Anna Szczepańska - Szerej
Lublin, 20-022, Poland
Zespol Poradni Specjalistycznych Reumed Filia Onyksowa
Lublin, 20-582, Poland
PROFMEDICUS Sp. z o.o., Osrodek Badan Klinicznych
Olsztyn, 10-357, Poland
Prywatna Praktyka Lekarska Prof. UM dr hab. med. Pawel Hrycaj
Poznan, 61-397, Poland
Pomorskie Centrum Reumatologiczne im. Dr Jadwigi Titz-Kosko w Sopocie, Spolka. z o.o.
Sopot, 81-759, Poland
KO-MED Centra Kliniczne Sp. zo.o.
Staszów, 28-200, Poland
NASZ LEKARZ Przychodnie Medyczne
Torun, 87-100, Poland
Centrum Medyczne Pratia Warszawa
Warsaw, 01-868, Poland
Rheuma Medicus Zaklad Opieki Zdrowotnej
Warsaw, 02-118, Poland
Synexus Polska Sp. z o.o.
Wroclaw, 50-281, Poland
NZOZ Biogenes Sp. z o.o.
Wroclaw, 53-224, Poland
Ponce Medical School Foundation, Inc.
Ponce, 00716, Puerto Rico
Fundacion de Investigaction de Diego
San Juan, 00927, Puerto Rico
Saint-Petersburg State Budgetary Institution of Healthcare Municipal hospital # 40 of the
Saint Petersburg, St.petersburg, 197706, Russia
SBHI City Clinical Hospital #4 of HD of Moscow
Moscow, 115093, Russia
SBHI of Moscow City Clinical Hospital 1 n. a. N.I. Pirogov of the Healthcare Department of Moscow
Moscow, 119049, Russia
SBIH of Nizhniy Novgorod region City Clinical Hospital #5 of Nizhniy Novgorod district
Nizhny Novgorod, 603005, Russia
Federal State Budgetary Scientific Institution "Research Institute of Fundamental and
Novosibirsk, 630075, Russia
Consulting and Diagnostic Rheumatological Center Healthy Joints LLC
Novosibirsk, 630099, Russia
GBUZ RK Republic Hospital n. a. V.A. Baranov of the MoH & social development Of The Karelia Republic
Petrozavodsk, 185000, Russia
Saint-Petersburg State Budget Healthcare Institution Consultative-diagnostic Center #85
Saint Petersburg, 198260, Russia
Federal State Budgetary Educational Institution of Higher Education
Smolensk, 214019, Russia
SBEI of HPE Ural State Medical University of the MoH of the RF
Yekaterinburg, 620028, Russia
Municipal Budgetary Institution "Central City Clinical Hospital #6"
Yekaterinburg, 620149, Russia
Nestatna reumatologicka ambulancia
Bratislava, 841 04, Slovakia
ROMJAN s.r. o. , Specializovana Reumatologicka ambulancia
Bratislava - Petrzalka, 851 01, Slovakia
AAGS, s.r.o., Reumatologicka ambulancia
Dunajská Streda, 929 01, Slovakia
ECCLESIA s.r.o, Reumatologicka ambulancia
Nové Zámky, 940 01, Slovakia
REUMACENTRUM s.r.o., Reumatologicka ambulancia
Partizánske, 958 01, Slovakia
Reumex s.r.o
Rimavská Sobota, 979 01, Slovakia
Reuma-Global s.r.o., Reumatologicka ambulancia
Trnava, 91701, Slovakia
Greenacres Hospital
Port Elizabeth, Eastern Cape, 6045, South Africa
Wits Clinical Research Site
Johannesburg, Gauteng, 2193, South Africa
Clinresco Centres ( Pty ) Ltd
Kempton Park, Gauteng, 1619, South Africa
Jakaranda Hospital
Pretoria, Gauteng, 0002, South Africa
Emmed Research
Pretoria, Gauteng, 0084, South Africa
St. Augustine's Hospital - Chelmsford Medical Centre 2
Durban, KwaZulu-Natal, 4001, South Africa
Tiervlei Trial Centre, Karl Bremer Hospital
Bellville, Cape Town, Western Cape, 7530, South Africa
Arthritis Clinical Research Trials cc
Cape Town, Western Cape, 7405, South Africa
Panorama Medical Centre
Cape Town, Western Cape, 7500, South Africa
University of Cape Town
Cape Town, Western Cape, 7925, South Africa
Winelands Medical Research Centre-
Stellenbosch, 7600, South Africa
Hospital de Merida
Mérida, Badajoz, 06800, Spain
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, 39008, Spain
Hospital Nuestra Senora de la Esperanza
Santiago de Compostela, LA Coruna, 15705, Spain
Hospital Universitario de Cruces
Barakaldo, Vizcaya, 48903, Spain
Hospital Universitario de Basurto
Bilbao, Vizcaya, 48013, Spain
Hospital Plato
Barcelona, 08006, Spain
Hospital De La Santa Creu I Sant Pau
Barcelona, 08025, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Regional Universitario de Malaga
Málaga, 29009, Spain
Hospital Universitario Virgen de la Macarena
Seville, 41009, Spain
China Medical University Hospital
Taichung, Taiwan (r.o.c), 40447, Taiwan
Changhua Christian Hospital
Changhua, 500, Taiwan
Buddhist Dalin Tzu Chi General Hospital
Chiayi City, 62247, Taiwan
Chung Shan Medical University Hospital
Taichung, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Chang Gung Medical Foundation - Linkou Branch
Taoyuan, 33305, Taiwan
Phramongkutklao Hospital
Bangkok, 10400, Thailand
Ramathibodi Hospital, Mahidol University
Bangkok, 10400, Thailand
Faculty of Medicine , Siriraj Hospital , Mahidol University
Bangkok, 10700, Thailand
Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine,Chiang Mai University
Chiang Mai, 50200, Thailand
Prince of Songkla University
Songkhla, 90110, Thailand
Ankara Universitesi Tip Fakultesi Ibn-i Sina Hastanesi
Ankara, 06100, Turkey (Türkiye)
Hacettepe Universitesi Tip Fakultesi
Ankara, 06100, Turkey (Türkiye)
Adnan Menderes Universitesi Tip Fakultesi Hastanesi
Aydin, 09010, Turkey (Türkiye)
Gaziantep Universitesi Tip Fakultesi
Gaziantep, 27310, Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa Tip Fakultesi
Istanbul, 34098, Turkey (Türkiye)
Izmir Tepecik Egitim ve Arastirma Hastanesi
Izmir, 35180, Turkey (Türkiye)
Kocaeli Universitesi Tip Fakultesi Hastanesi
Kocaeli, 41380, Turkey (Türkiye)
Ondokuz Mayis Universitesi Tip Fakultesi Fiziksel Tip ve
Samsun, 55200, Turkey (Türkiye)
Cumhuriyet Universitesi Tip Fakultesi Hastanesi
Sivas, 58140, Turkey (Türkiye)
Poole Hospital, University Hospitals Dorset NHS Foundation Trust
Poole, Dorset, BH152JB, United Kingdom
Barking, Havering and Redbridge University Hospitals NHS Trust
Goodmayes, Essex, IG3 8YB, United Kingdom
The Royal Wolverhampton NHS Trust-Cannock Chase Hospital
Cannock, WS11 5XY, United Kingdom
Aintree University Hospital, Liverpool University Hospitals
Liverpool, L9 7AL, United Kingdom
Clinical trials, Pharmacy Department, Aintree University Hospitals
Liverpool, L9 7AL, United Kingdom
University of Liverpool Academic Rheumatology Unit. Aintree University Hospital. Liverpool Universit
Liverpool, L9 7AL, United Kingdom
The Newcastle Upon Tyne Hospitals NHS Foundation Trust, Clinical Research Facility
Newcastle upon Tyne, NE1 4LP, United Kingdom
Northumbria Healthcare NHS Foundation Trust
North Shields, NE29 8NH, United Kingdom
Pharmacy Department
Wolverhampton, WV10 0QP, United Kingdom
Related Publications (13)
Giles JT, Charles-Schoeman C, Buch MH, Dougados M, Szekanecz Z, Mikuls TR, Ytterberg SR, Koch GG, Kwok K, Cadatal MJ, Menon S, Chen Y, Diehl AM, Rivas JL, Yndestad A, Bhatt DL. Use of statins and its association with major adverse cardiovascular events with tofacitinib vs TNF inhibitors in patients with rheumatoid arthritis with and without atherosclerotic cardiovascular disease. Ann Rheum Dis. 2026 Jan;85(1):103-113. doi: 10.1016/j.ard.2025.08.028. Epub 2025 Sep 23.
PMID: 40992967DERIVEDHetland ML, Strangfeld A, Bonfanti G, Soudis D, Deuring JJ, Edwards RA. Machine learning prediction and explanatory models of serious infections in patients with rheumatoid arthritis treated with tofacitinib. Arthritis Res Ther. 2024 Aug 27;26(1):153. doi: 10.1186/s13075-024-03376-9.
PMID: 39192350DERIVEDBatko B, Jeka S, Wiland P, Zielinska A, Stopinska-Polaszewska M, Stajszczyk M, Kosydar-Piechna M, Cadatal MJ, Rivas JL. Geographical Differences in the Safety and Efficacy of Tofacitinib Versus TNFi: A Post Hoc Analysis of ORAL Surveillance. Rheumatol Ther. 2024 Oct;11(5):1217-1235. doi: 10.1007/s40744-024-00693-y. Epub 2024 Jul 26.
PMID: 39060905DERIVEDCitera G, Mysler E, Kakehasi AM, Pascual-Ramos V, Masson W, Cadatal MJ, Rivas JL, Sheibanie F, Helling C, Ponce de Leon D. Cardiovascular Events, Malignancies, and Efficacy Outcomes in Latin American Patients With Rheumatoid Arthritis Receiving Tofacitinib or Tumor Necrosis Factor Inhibitors: A Post Hoc Analysis of the ORAL Surveillance Study. J Clin Rheumatol. 2024 Aug 1;30(5):208-216. doi: 10.1097/RHU.0000000000002106. Epub 2024 Jun 17.
PMID: 38880956DERIVEDBuch MH, Bhatt DL, Charles-Schoeman C, Giles JT, Mikuls T, Koch GG, Ytterberg S, Nagy E, Jo H, Kwok K, Connell CA, Masri KR, Yndestad A. Risk of extended major adverse cardiovascular event endpoints with tofacitinib versus TNF inhibitors in patients with rheumatoid arthritis: a post hoc analysis of a phase 3b/4 randomised safety study. RMD Open. 2024 Apr 12;10(2):e003912. doi: 10.1136/rmdopen-2023-003912.
PMID: 38609322DERIVEDKarpouzas GA, Szekanecz Z, Baecklund E, Mikuls TR, Bhatt DL, Wang C, Sawyerr GA, Chen Y, Menon S, Connell CA, Ytterberg SR, Mortezavi M. Rheumatoid arthritis disease activity and adverse events in patients receiving tofacitinib or tumor necrosis factor inhibitors: a post hoc analysis of ORAL Surveillance. Ther Adv Musculoskelet Dis. 2023 Nov 6;15:1759720X231201047. doi: 10.1177/1759720X231201047. eCollection 2023.
PMID: 37942277DERIVEDKristensen LE, Danese S, Yndestad A, Wang C, Nagy E, Modesto I, Rivas J, Benda B. Identification of two tofacitinib subpopulations with different relative risk versus TNF inhibitors: an analysis of the open label, randomised controlled study ORAL Surveillance. Ann Rheum Dis. 2023 Jul;82(7):901-910. doi: 10.1136/ard-2022-223715. Epub 2023 Mar 17.
PMID: 36931693DERIVEDHansen KE, Mortezavi M, Nagy E, Wang C, Connell CA, Radi Z, Litman HJ, Adami G, Rossini M. Fracture in clinical studies of tofacitinib in rheumatoid arthritis. Ther Adv Musculoskelet Dis. 2022 Dec 27;14:1759720X221142346. doi: 10.1177/1759720X221142346. eCollection 2022.
PMID: 36601090DERIVEDCurtis JR, Yamaoka K, Chen YH, Bhatt DL, Gunay LM, Sugiyama N, Connell CA, Wang C, Wu J, Menon S, Vranic I, Gomez-Reino JJ. Malignancy risk with tofacitinib versus TNF inhibitors in rheumatoid arthritis: results from the open-label, randomised controlled ORAL Surveillance trial. Ann Rheum Dis. 2023 Mar;82(3):331-343. doi: 10.1136/ard-2022-222543. Epub 2022 Dec 5.
PMID: 36600185DERIVEDWeitz 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.
PMID: 36323490DERIVEDCharles-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.
PMID: 36137735DERIVEDBalanescu 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.
PMID: 35922124DERIVEDYtterberg 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.
PMID: 35081280DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2014
First Posted
March 20, 2014
Study Start
March 14, 2014
Primary Completion
July 22, 2020
Study Completion
July 22, 2020
Last Updated
August 17, 2021
Results First Posted
August 17, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.