Clinical trial NCT02187055: An Efficacy And Safety Study Evaluating Tofacitinib With And Without Methotrexate Compared To Adalimumab With Methotrexate
Official title: A Phase 3b/4 Randomized Double Blind Study Of 5 Mg Of Tofacitinib With And Without Methotrexate In Comparison To Adalimumab With Methotrexate In Subjects With Moderately To Severely Active Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rhematoid Arthritis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-07-10
Enrollment: 1152
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: To assess the efficacy of tofacitinib monotherapy or tofacitinib with methotrexate as compared to adalimumab with methotrexate. To compare the efficacy of tofacitinib monotherapy compared to tofacitinib combined with methotrexate. To compare effects on all health outcomes measures in the study. To evaluate the safety and tolerability of tofacitinib and adalimumab. To evaluate the safety of the zoster vaccine given prior to the initiation of tofacitinb or adalimumab.


Eligibility criteria: Inclusion Criteria:

* Have moderate to severe rheumatoid arthritis
* On methotrexate but inadequately controlled
* Subjects must not have active tuberculosis or an inadequately treated tuberculosis infection
* Subjects must use contraception

Exclusion Criteria:

* Subjects who have been previously treated with adalimumab or Tofacitinib
* Subjects with any current malignancy or a history of malignancy, with the exception of adequately treated or excised non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
* Subjects with specific laboratory test abnormalities
* Subjects with specific types of infections

Primary outcomes:
measure: Percentage of Participants Achieving American College of Rheumatology Criteria 50% Improvement (ACR50) Response at Month 6
timeFrame: Month 6
Secondary outcomes:
measure: Change From Baseline in Simplified Disease Activity Index (SDAI) Value at Month 6
timeFrame: Month 6
measure: Change From Baseline in Clinical Disease Activity Index (CDAI) Value at Month 6
timeFrame: Month 6
measure: Change From Baseline in Disease Activity Score 28-4 (DAS28-4) Including CRP at Month 6
timeFrame: Month 6
measure: Change From Baseline in Disease Activity Score 28-4 (DAS28-4) Including Erythrocyte Sedimentation Rate (ESR) at Month 6
timeFrame: Month 6
measure: Percentage of Participants Achieving Observed American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) Boolean Remission Criteria at Month 6
timeFrame: Month 6
measure: Percentage of Participants Achieving SDAI ≤3.3 at Month 6
timeFrame: Month 6
measure: Percentage of Participants Achieving CDAI ≤2.8 at Month 6
timeFrame: Month 6
measure: Percentage of Participants Achieving DAS28-4 (ESR) <2.6 at Month 6
timeFrame: Month 6
measure: Percentage of Participants Achieving DAS28-4 (CRP) <2.6 at Month 6
timeFrame: Month 6
measure: Percentage of Participants Achieving SDAI ≤11 at Month 6
timeFrame: Month 6
measure: Percentage of Participants Achieving CDAI ≤10 at Month 6
timeFrame: Month 6
measure: Percentage of Participants Achieving DAS28-4 (ESR) ≤3.2 at Month 6
timeFrame: Month 6
measure: Percentage of Participants Achieving DAS28-4 (CRP) ≤3.2 at Month 6
timeFrame: Month 6
measure: Percentage of Participants Achieving American College of Rheumatology Criteria 20% Improvement (ACR20) Response at Month 6
timeFrame: Month 6
measure: Percentage of Participants Achieving American College of Rheumatology Criteria 70% Improvement (ACR70) Response at Month 6
timeFrame: Month 6
measure: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Month 6
timeFrame: Month 6
measure: Percentage of Participants Achieving an HAQ-DI Decrease of at Least 0.22 at Month 6
timeFrame: Month 6
measure: Change From Baseline in the Short-Form-36 (SF-36) Health Survey, Physical Component Score at Month 6
timeFrame: Month 6
measure: Change From Baseline in the SF-36 Health Survey, Mental Component Score at Month 6
timeFrame: Month 6
measure: Change From Baseline in the SF-36 Health Survey, Physical Functioning Domain Score at Month 6
timeFrame: Month 6
measure: Change From Baseline in the SF-36 Health Survey, Role Physical Domain Score at Month 6
timeFrame: Month 6
measure: Change From Baseline in the SF-36 Health Survey, Bodily Pain Domain Score at Month 6
timeFrame: Month 6
measure: Change From Baseline in the SF-36 Health Survey, General Health Domain Score at Month 6
timeFrame: Month 6
measure: Change From Baseline in the SF-36 Health Survey, Vitality Domain Score at Month 6
timeFrame: Month 6
measure: Change From Baseline in the SF-36 Health Survey, Social Functioning Domain Score at Month 6
timeFrame: Month 6
measure: Change From Baseline in the SF-36 Health Survey, Role Emotional Domain Score at Month 6
timeFrame: Month 6
measure: Change From Baseline in the SF-36 Health Survey, Mental Health Domain Score at Month 6
timeFrame: Month 6
measure: Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire at Month 6
timeFrame: Month 6
measure: Change From Baseline in the EuroQol European Quality of Life-5 Dimensions (EuroQol EQ-5D) at Month 6
timeFrame: Month 6
measure: Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale Total Score at Month 6
timeFrame: Month 6
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Rheumatology Associates of North Alabama, PC
state: Alabama
city: Gilbert
country: United States
facility: Arthrocare, Arthritis Care & Research, PC
state: Arizona
city: Covina
country: United States
facility: Medvin Clinical Research
state: California
city: Fullerton
country: United States
facility: St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare
state: California
city: Huntington Beach
country: United States
facility: HealthCare Partners Medical Group
state: California
city: Los Angeles
country: United States
facility: Keck Medicine of USC - Division of Rheumatology
state: California
city: Los Angeles
country: United States
facility: University of Southern California (USC) Norris Comprehensive Cancer Center
state: California
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center - Drug Information Center
state: California
city: Los Angeles
country: United States
facility: UCLA David Geffen School of Medicine, Division of Rheumatology
state: California
city: Placentia
country: United States
facility: Medvin Clinical Research
state: California
city: San Diego
country: United States
facility: San Diego Arthritis Medical Clinic
state: California
city: Upland
country: United States
facility: Inland Rheumatology Clinical Trials, Inc.
state: California
city: Van Nuys
country: United States
facility: Medvin Clinical Research
state: California
city: Whittier
country: United States
facility: Medvin Clinical Research
state: California
city: Bridgeport
country: United States
facility: Joao M. A. Nascimento
state: Connecticut
city: Aventura
country: United States
facility: AARDS Research, Inc.
state: Florida
city: Aventura
country: United States
facility: Arthritis and Rheumatic Disease Specialties
state: Florida
city: Edgewater
country: United States
facility: Riverside Clinical Research
state: Florida
city: Fort Lauderdale
country: United States
facility: Centre for Rheumatology, Immunology and Arthritis
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Orlando
country: United States
facility: Omega Research Consultants, LLC
state: Florida
city: Palm Harbor
country: United States
facility: Arthritis Center, Inc.
state: Florida
city: Pensacola
country: United States
facility: Gulf Region Clinical Research Institute Llc
state: Florida
city: Tamarac
country: United States
facility: West Broward Rheumatology Associates, Inc.
state: Florida
city: Tampa
country: United States
facility: BayCare Medical Group Inc
state: Florida
city: Vero Beach
country: United States
facility: The Center for Arthritis and Rheumatism
state: Florida
city: Vero Beach
country: United States
facility: The Office of Alastair C. Kennedy, MD
state: Florida
city: Winter Garden
country: United States
facility: Advanced Clinical Research of Orlando, Inc.
state: Florida
city: Coeur d'Alene
country: United States
facility: Coeur D'Alene Arthritis Clinic
state: Idaho
city: Idaho Falls
country: United States
facility: Institute of Arthritis Research
state: Idaho
city: Vernon Hills
country: United States
facility: Deerbrook Medical Associates
state: Illinois
city: Indianapolis
country: United States
facility: Diagnostic Rheumatology and Research PC
state: Indiana
city: Baton Rouge
country: United States
facility: Ochsner Clinic Baton Rouge
state: Louisiana
city: Monroe
country: United States
facility: Arthritis and Diabetes Clinic, Inc
state: Louisiana
city: Frederick
country: United States
facility: Arthritis Treatment Center
state: Maryland
city: Kalamazoo
country: United States
facility: Jasper Clinic
state: Michigan
city: Flowood
country: United States
facility: Arthritis and Osteoporosis Treatment and Research Center
state: Mississippi
city: Saint Louis
country: United States
facility: St. Louis Center For Clinical Research Barbara Caciolo, MD
state: Missouri
city: Springfield
country: United States
facility: Clinvest/ A Division of Banyan Group, Inc.
state: Missouri
city: Plainview
country: United States
facility: Dr. Prem C. Chatpar M.D.,LLC
state: New York
city: Salisbury
country: United States
facility: PMG Research of Salisbury, LLC
state: North Carolina
city: Salisbury
country: United States
facility: Rowan Diagnostic Clinic
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington
state: North Carolina
city: Minot
country: United States
facility: Trinity Health Center - Medical Arts
state: North Dakota
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: Arthritis Group
state: Pennsylvania
city: Charleston
country: United States
facility: Low Country Rheumatology, PA
state: South Carolina
city: Jackson
country: United States
facility: West Tennessee Research Institute
state: Tennessee
city: Baytown
country: United States
facility: Accurate Clinical Management, LLC
state: Texas
city: Dallas
country: United States
facility: Arthritis Care And Diagnostic Center, P.A.
state: Texas
city: Dallas
country: United States
facility: Metroplex Clinical Research Center
state: Texas
city: Houston
country: United States
facility: Accurate Clinical Management, LLC
state: Texas
city: Houston
country: United States
facility: Rheumatology Clinic of Houston, PA
state: Texas
city: Houston
country: United States
facility: Houston Institute For Clinical Research
state: Texas
city: Lubbock
country: United States
facility: Arthritis & Osteoporosis Associates, LLP
state: Texas
city: Mesquite
country: United States
facility: Southwest Rheumatology Research, LLC.
state: Texas
city: San Antonio
country: United States
facility: Accurate Clinical Research, Inc.
state: Texas
city: San Antonio
country: United States
facility: Arthritis & Osteoporosis Center of South Texas
state: Texas
city: Spokane
country: United States
facility: Arthritis Northwest, PLLC
state: Washington
city: Caba
country: Argentina
facility: Atencion Integral en Reumatologia (AIR)
state: Buenos Aires
city: San Miguel de Tucuman
country: Argentina
facility: Centro Medico Privado de Reumatologia
state: Tucuman
city: San Miguel de Tucuman
country: Argentina
facility: Centro Radiologico Luis Mendez Collado SRL
state: Tucuman
city: Buenos Aires
country: Argentina
facility: Organizacion Medica de Investigacion S.A - OMI
city: San Juan
country: Argentina
facility: CER San Juan, Centro Polivalente de Asistencia e Investigacion Clinica
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Southport
country: Australia
facility: Pacific Private Clinic
state: Queensland
city: Southport
country: Australia
facility: QML Pathology
state: Queensland
city: Woodville South
country: Australia
facility: The Queen Elizabeth Hospital
state: South Australia
city: Malvern East
country: Australia
facility: Emeritus Research
state: Victoria
city: Victoria Park
country: Australia
facility: RK Will Pty Ltd
state: Western Australia
city: Banja Luka
country: Bosnia and Herzegovina
facility: University Hospital Clinical Center Banja Luka
state: Republika Srpska
city: Tuzla
country: Bosnia and Herzegovina
facility: University Clinical Center Tuzla
city: Pleven
country: Bulgaria
facility: UMHAT "Dr. Georgi Stranski" EAD
city: Plovdiv
country: Bulgaria
facility: MHAT "Kaspela" EOOD
city: Plovdiv
country: Bulgaria
facility: MHAT EUROHOSPITAL Plovdiv
city: Ruse
country: Bulgaria
facility: MHAT Akta Medika OOD
city: Ruse
country: Bulgaria
facility: MHAT Ruse AD
city: Shumen
country: Bulgaria
facility: MHAT Shumen AD
city: Sofia
country: Bulgaria
facility: NMTH Tsar Boris Clinic of Internal Diseases
city: Sofia
country: Bulgaria
facility: MHAT Lyulin EAD
city: Targovisthe
country: Bulgaria
facility: MHAT "Targovishte" AD
city: Kitchener
country: Canada
facility: Kw Musculoskeletal Research Inc
state: Ontario
city: Trois-Rivieres
country: Canada
facility: Centre de Recherche Musculo-Squelettique
state: Quebec
city: Santiago
country: Chile
facility: Prosalud
state: Metropolitana
city: Vina del Mar
country: Chile
facility: Estudios Clinicos Quinta Region Ltda.
state: Valparaiso
city: Puerto Varas
country: Chile
facility: Quantum Research Ltda
state: X Region
city: Puerto Varas
country: Chile
facility: Quantum Research
state: X Region
city: Brno - Zidenice
country: Czechia
facility: Revmacentrum MUDr. Mostera, s.r.o.
state: Czech Republic
city: Brno
country: Czechia
facility: Revmatologie s.r.o.
city: Ceska Lipa
country: Czechia
facility: Revmatologicka ambulance
city: Ostrava- Moravska Ostrava
country: Czechia
facility: Vesalion, s.r.o.
city: Praha 4
country: Czechia
facility: Revmatologie
city: Parnu
country: Estonia
facility: Foundation Parnu Hospital
city: Tallinn
country: Estonia
facility: East-Tallinn Central Hospital Ltd
city: Tallinn
country: Estonia
facility: North Estonia Medical Centre Foundation
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Tel-Hashomer
country: Israel
facility: The Chaim Sheba Medical Center
city: Jung-Gu
country: Korea, Republic of
facility: Inha University Hospital
state: Incheon
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Riga
country: Latvia
facility: Health Center 4
city: Riga
country: Latvia
facility: ORTO clinic Ltd
city: Alytus
country: Lithuania
facility: Alytaus District S. Kudirkos Hospital
city: Kaunas
country: Lithuania
facility: VAKK "Clinic of Dr. Kilda"
city: Siauliai
country: Lithuania
facility: PI Republican Siauliai Hospital
city: Torreon
country: Mexico
facility: Unidad de Enfermedades Reumaticas y Cronico Degenerativas S. C.
state: Coahuila
city: Mexico
country: Mexico
facility: CINTRE, Centro de Investigacion y Tratamiento Reumatologico S.C. Consultorio Medico de Reumatologia
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Centro Integral en Reumatologia, SA de CV
state: Jalisco
city: Culiacan
country: Mexico
facility: Centro de Investigacion de Tratamientos Innovadores de Sinaloa S.C.
state: Sinaloa
city: Culiacan
country: Mexico
facility: Centro de Investigacion en Tratamientos Innovadores de Sinaloa S.C.
state: Sinaloa
city: Merida
country: Mexico
facility: Centro Multidisciplinario para el Desarrollo Especializado de la Invetigacion Clinica en Yucatan
state: Yucatan
city: Merida
country: Mexico
facility: Departamento de Imagen de Hospital Star Medica Merida
state: Yucatan
city: Merida
country: Mexico
facility: Laboratorio clínico del Hospital Star Medica Merida
state: Yucatan
city: Merida
country: Mexico
facility: Storage for lab kits and study materials
state: Yucatan
city: Chihuahua
country: Mexico
facility: Investigacion y Biomedica de Chihuahua, SC
city: Jalisco
country: Mexico
facility: Centro de Integral en Reumatologia SA de CV
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 A.C.
city: Arequipa
country: Peru
facility: Unidad de Investigacion en Medicina Interna y Enfermedades criticas-Hogar Clinica San Juan de Dios
city: Lima
country: Peru
facility: ABK REUMAR S.R.L. de Medicentro Biociencias_ BIO CIENCIAS PERU S.R.L.
city: Lima
country: Peru
facility: Instituto Peruano del Hueso y la Articulacion
city: Lima
country: Peru
facility: Investigaciones Clinicas S.A.C.
city: Lipa City
country: Philippines
facility: Mary Mediatrix Medical Center
state: Batangas
city: Davao
country: Philippines
facility: Brokenshire Integrated Health Ministries, Inc.
state: Davao DEL SUR
city: Iloilo City
country: Philippines
facility: Iloilo Doctors' Hospital, Inc
state: Iloilo
city: Manila
country: Philippines
facility: University of the Philippines Manila-Philippine General Hospital
state: Metro Manila
city: Manila
country: Philippines
facility: Jose R. Reyes Memorial Medical Center-Rayuma Klinik
state: Metro Manila
city: Quezon City
country: Philippines
facility: St. Luke's Medical Center
state: Metro Manila
city: Quezon City
country: Philippines
facility: Far Eastern University - NRMF Medical Center
state: Metro Manila
city: Cebu City
country: Philippines
facility: Perpetual Succour Hospital
city: Davao
country: Philippines
facility: Davao Doctors Hospital
city: Iloilo City
country: Philippines
facility: St. Paul's Hospital of Iloilo, Inc.
city: Krakow
country: Poland
facility: Medica Pro Familia Sp. z o.o. S.K.A. Oddzial Krakow
state: Malopolska
city: Warszawa
country: Poland
facility: Centrum Medyczne Amed
state: WOJ Mazowieckie
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy,
city: Bytom
country: Poland
facility: Centrum Medyczne SILESIANA Sp. z o.o.
city: Bytom
country: Poland
facility: Nzoz Bif-Med
city: Elblag
country: Poland
facility: Centrum Kliniczno-Badawcze J.Brzezicki, B.Gornikiewicz-Brzezicka
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: Lodz
country: Poland
facility: Centrum Terapii Wspolczesnej J.M. Jasnorzewska Spolka Komandytowo-Akcyjna
city: Nadarzyn
country: Poland
facility: Lecznica MAK-MED, NZOZ
city: Poznan
country: Poland
facility: Prywatna Praktyka Lekarska
city: Warszawa
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial w Warszawie
city: Warszawa
country: Poland
facility: MTZ Clinical Research Sp. z o.o.
city: Wroclaw
country: Poland
facility: Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
city: Cluj Napoca
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Cluj Napoca Reumatologie
state: Cluj
city: Sfantu Gheorghe
country: Romania
facility: Covamed Serv SRL
state: Covasna
city: Baia Mare
country: Romania
facility: Spitalul Judetean de Urgenta "Dr. Constantin Opris"
state: Maramures
city: Baia Mare
country: Romania
facility: S.C. Clinica Somesan S.R.L.
state: Maramures
city: Bucuresti
country: Romania
facility: Ianuli Med Consult SRL, Reumatologie
city: Bucuresti
country: Romania
facility: Spitalul Clinic Sf. Maria, Medicina interna - Reumatologie
city: Bucuresti
country: Romania
facility: Spitalul Clinic Sf. Maria
city: Bucuresti
country: Romania
facility: Spitalul Clinic "Dr. I. Cantacuzino"
city: Bucuresti
country: Romania
facility: Centrul Clinic de Boli Reumatismale "Dr. Ion Stoia"
city: Galati
country: Romania
facility: Spitalul Clinic Judetean de Urgenta - "Sf.Apostol Andrei" Galati
city: Iasi
country: Romania
facility: Spitalul Clinic de Recuperare Iasi
city: Petrozawodsk
country: Russian Federation
facility: Republic Hospital n.a. V.A. Baranov
state: Karelia Republic
city: Petrozawodsk
country: Russian Federation
facility: State Budgetary Healthcare Institution of Karelia Republic "Republic Hospital n.a. V.A. Baranov"
state: Karelia Republic
city: Kemerovo
country: Russian Federation
facility: SAHI of KR "Kemerovo Regional Clinical Hospital"
city: Moscow
country: Russian Federation
facility: SBEI HPE First Moscow State Medical University n.a.I.M.Sechenov of MoH of RF based on UCH#1
city: Moscow
country: Russian Federation
facility: CJSC "European Medical Center"
city: Novosibirsk
country: Russian Federation
facility: SBEI HPE Novosibirsk State Medical University of MoH of RF
city: Orenburg
country: Russian Federation
facility: State Budgetary Healthcare Institution "Orenburg Regional Clinical Hospital"
city: Ryazan
country: Russian Federation
facility: State Budgetary Institution of Ryazan Region "Regional Clinical Cardiology Dispensary"
city: Saint Petersburg
country: Russian Federation
facility: Limited Liability Company AVA-PETER
city: Samara
country: Russian Federation
facility: State Budgetary Institution of Healthcare "Samara Regional Clinical Hospital n.a. V.D. Seredavin"
city: Saratov
country: Russian Federation
facility: State Institution of Healthcare "Regional Clinical Hospital"
city: Smolensk
country: Russian Federation
facility: Non-state Healthcare Institution "Regional Hospital at Smolensk Station of OJSC "Russian Railways"
city: Yaroslavl
country: Russian Federation
facility: State Autonomous Healthcare lnstitution of Yarostavl Region
city: Yaroslavl
country: Russian Federation
facility: State Budgetary Healthcare Institution of Yaroslavl Region "Clinical Hospital #3"
city: Bloemfontein
country: South Africa
facility: Iatros International
state: FREE State
city: Johannesburg
country: South Africa
facility: LCS Clinical Research Unit
state: Gauteng
city: Johannesburg
country: South Africa
facility: WCR: Wits Clinical Research Charlotte Maxeke Johannesburg Academic Hospital
state: Gauteng
city: Johannesburg
country: South Africa
facility: WCR: Wits Clinical Research
state: Gauteng
city: Parktown, Johannesburg
country: South Africa
facility: Charlotte Maxeke Johannesburg Academic Hospital
state: Gauteng
city: Pretoria
country: South Africa
facility: Clinical Research Unit, University of Pretoria
state: Gauteng
city: Pretoria
country: South Africa
facility: Netcare Jakaranda Hospital
state: Gauteng
city: Pretoria
country: South Africa
facility: University of Pretoria
state: Gauteng
city: Durban
country: South Africa
facility: Netcare St Augustine's Hospital
state: Kwazulu-natal
city: Cape Town
country: South Africa
facility: Arthritis Clinical Research Trials
state: Western CAPE
city: Cape Town
country: South Africa
facility: Panorama Medical Centre
state: Western CAPE
city: Stellenbosch
country: South Africa
facility: Wineland Medical Research Centre
state: Western CAPE
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago de Compostela, Hospital Clinico Universitario
state: A Coruna
city: A Coruna
country: Spain
facility: Complexo Hospitalario Universitario A Coruna
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Jimenez Diaz
city: Malaga
country: Spain
facility: Hospital Regional Universitario de Malaga
city: Sevilla
country: Spain
facility: Hospital Infanta Luisa
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
state: Taiwan ROC
city: Hualien
country: Taiwan
facility: Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital - New
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan County
country: Taiwan
facility: Chang Gung Medical Foundation - Linkou Branch
city: Bangkok
country: Thailand
facility: Phramongkutklao Hospital
state: Rajthevi
city: Bangkok
country: Thailand
facility: Cardiology Unit,Department of Medicine, Faculty of Medicine, Ramathibodi Hospital,Mahidol University
city: Bangkok
country: Thailand
facility: Div. of Allergy Immunology and Rheumatology, Dept. of Medicine,
city: Bangkok
country: Thailand
facility: Siriraj Hospital Mahidol University
city: Songkhla
country: Thailand
facility: Songklanagarind Hospital - Prince of Songkhla University
city: Ankara
country: Turkey
facility: Ankara Universitesi Tip Fakultesi Ibn-i Sina Hastanesi
city: Samsun
country: Turkey
facility: Ondokuz Mayis Universitesi Tip Fakultesi Saglik Uyg. ve Eg.
city: Samsun
country: Turkey
facility: Ondokuz Mayis Universitesi Tip Fakultesi Saglik Uygulama ve Egitim Merkezi
city: Sivas
country: Turkey
facility: Cumhuriyet Universitesi Tip Fakultesi Hastanesi
city: Dudley
country: United Kingdom
facility: The Dudley Group NHS Foundation Trust
state: WEST Midlands
city: Cannock
country: United Kingdom
facility: The Royal Wolverhamptons NHS Trust
city: Leeds
country: United Kingdom
facility: The Leeds Teaching Hospitals NHS Trust
city: Liverpool
country: United Kingdom
facility: Aintree University Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: Royal Free London NHS Foundation Trust
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Bessette L, Mysler E, Kinch CD, Kwok K, Lukic T, On PV, van Vollenhoven RF. Impact of Tofacitinib on Components of the ACR Response Criteria: Post Hoc Analysis of Phase III and Phase IIIb/IV Trials. J Rheumatol. 2022 Jun;49(6):566-576. doi: 10.3899/jrheum.210707. Epub 2022 Mar 1.
citation: Dikranian A, Gold D, Bessette L, Nash P, Azevedo VF, Wang L, Woolcott J, Shapiro AB, Szumski A, Fleishaker D, Wollenhaupt J. Frequency and Duration of Early Non-serious Adverse Events in Patients with Rheumatoid Arthritis and Psoriatic Arthritis Treated with Tofacitinib. Rheumatol Ther. 2022 Apr;9(2):411-433. doi: 10.1007/s40744-021-00405-w. Epub 2021 Dec 17.
citation: Winthrop KL, Curtis JR, Yamaoka K, Lee EB, Hirose T, Rivas JL, Kwok K, Burmester GR. Clinical Management of Herpes Zoster in Patients With Rheumatoid Arthritis or Psoriatic Arthritis Receiving Tofacitinib Treatment. Rheumatol Ther. 2022 Feb;9(1):243-263. doi: 10.1007/s40744-021-00390-0. Epub 2021 Dec 6.
citation: Takeuchi T, Fleischmann R, Iikuni N, Shi H, Soma K, Paulissen J, Hirose T, Smolen JS. Differences and similarities in clinical and functional responses among patients receiving tofacitinib monotherapy, tofacitinib plus methotrexate, and adalimumab plus methotrexate: a post hoc analysis of data from ORAL Strategy. Arthritis Res Ther. 2021 Aug 24;23(1):220. doi: 10.1186/s13075-021-02591-y.
citation: Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Wang L, Chen C, Kwok K, Biswas P, Shapiro A, Madsen A, Wollenhaupt J. Long-term safety of tofacitinib up to 9.5 years: a comprehensive integrated analysis of the rheumatoid arthritis clinical development programme. RMD Open. 2020 Oct;6(3):e001395. doi: 10.1136/rmdopen-2020-001395.
citation: Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20.
citation: Strand V, Mysler E, Moots RJ, Wallenstein GV, DeMasi R, Gruben D, Soma K, Iikuni N, Smolen JS, Fleischmann R. Patient-reported outcomes for tofacitinib with and without methotrexate, or adalimumab with methotrexate, in rheumatoid arthritis: a phase IIIB/IV trial. RMD Open. 2019 Oct 1;5(2):e001040. doi: 10.1136/rmdopen-2019-001040. eCollection 2019.
citation: Calabrese LH, Abud-Mendoza C, Lindsey SM, Lee SH, Tatulych S, Takiya L, Iikuni N, Soma K, Luo Z, Fleischmann R. Live Zoster Vaccine in Patients With Rheumatoid Arthritis Treated With Tofacitinib With or Without Methotrexate, or Adalimumab With Methotrexate: A Post Hoc Analysis of Data From a Phase IIIb/IV Randomized Study. Arthritis Care Res (Hoboken). 2020 Mar;72(3):353-359. doi: 10.1002/acr.24010.
citation: Fleischmann R, Mysler E, Hall S, Kivitz AJ, Moots RJ, Luo Z, DeMasi R, Soma K, Zhang R, Takiya L, Tatulych S, Mojcik C, Krishnaswami S, Menon S, Smolen JS; ORAL Strategy investigators. Efficacy and safety of tofacitinib monotherapy, tofacitinib with methotrexate, and adalimumab with methotrexate in patients with rheumatoid arthritis (ORAL Strategy): a phase 3b/4, double-blind, head-to-head, randomised controlled trial. Lancet. 2017 Jul 29;390(10093):457-468. doi: 10.1016/S0140-6736(17)31618-5. Epub 2017 Jun 16.