An Efficacy And Safety Study Evaluating Tofacitinib With And Without Methotrexate Compared To Adalimumab With Methotrexate
NCT ID: NCT02187055
Last Updated: 2018-06-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
1152 participants
INTERVENTIONAL
2014-08-31
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Tofacitinib 5 mg twice daily with methotrexate
Tofacitinib with methotrexate
Tofacitinib 5 mg twice daily, oral for 12 months Methotrexate (previous stable dose 15-25 mg) every week, oral for 12 months Placebo for adalimumab every other week, subcutaneous for 12 months
Tofacitinib 5 mg twice daily monotherapy
Tofacitinib without methotrexate
Tofacitinib 5 mg twice daily, oral for 12 months Placebo for methotrexate (previous stable dose) every week, oral for 12 months Placebo for adalimumab every other week, subcutaneous for 12 months
Adalimumab with methotrexate
Adalimumab with methotrexate
Placebo for tofacitinib twice daily, oral for 12 months Methotrexate (previous stable dose 15-25 mg) every week, oral for 12 months Adalimumab 40 mg every other week, subcutaneous for 12 months
Interventions
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Tofacitinib with methotrexate
Tofacitinib 5 mg twice daily, oral for 12 months Methotrexate (previous stable dose 15-25 mg) every week, oral for 12 months Placebo for adalimumab every other week, subcutaneous for 12 months
Tofacitinib without methotrexate
Tofacitinib 5 mg twice daily, oral for 12 months Placebo for methotrexate (previous stable dose) every week, oral for 12 months Placebo for adalimumab every other week, subcutaneous for 12 months
Adalimumab with methotrexate
Placebo for tofacitinib twice daily, oral for 12 months Methotrexate (previous stable dose 15-25 mg) every week, oral for 12 months Adalimumab 40 mg every other week, subcutaneous for 12 months
Eligibility Criteria
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Inclusion Criteria
* On methotrexate but inadequately controlled
* Subjects must not have active tuberculosis or an inadequately treated tuberculosis infection
* Subjects must use contraception
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Rheumatology Associates of North Alabama, PC
Huntsville, Alabama, United States
Arthrocare, Arthritis Care & Research, PC
Gilbert, Arizona, United States
Medvin Clinical Research
Covina, California, United States
St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare
Fullerton, California, United States
HealthCare Partners Medical Group
Huntington Beach, California, United States
Keck Medicine of USC - Division of Rheumatology
Los Angeles, California, United States
University of Southern California (USC) Norris Comprehensive Cancer Center
Los Angeles, California, United States
Ronald Reagan UCLA Medical Center - Drug Information Center
Los Angeles, California, United States
UCLA David Geffen School of Medicine, Division of Rheumatology
Los Angeles, California, United States
Medvin Clinical Research
Placentia, California, United States
San Diego Arthritis Medical Clinic
San Diego, California, United States
Inland Rheumatology Clinical Trials, Inc.
Upland, California, United States
Medvin Clinical Research
Van Nuys, California, United States
Medvin Clinical Research
Whittier, California, United States
Joao M. A. Nascimento
Bridgeport, Connecticut, United States
AARDS Research, Inc.
Aventura, Florida, United States
Arthritis and Rheumatic Disease Specialties
Aventura, Florida, United States
Riverside Clinical Research
Edgewater, Florida, United States
Centre for Rheumatology, Immunology and Arthritis
Fort Lauderdale, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Omega Research Consultants, LLC
Orlando, Florida, United States
Arthritis Center, Inc.
Palm Harbor, Florida, United States
Gulf Region Clinical Research Institute Llc
Pensacola, Florida, United States
West Broward Rheumatology Associates, Inc.
Tamarac, Florida, United States
BayCare Medical Group Inc
Tampa, Florida, United States
The Center for Arthritis and Rheumatism
Vero Beach, Florida, United States
The Office of Alastair C. Kennedy, MD
Vero Beach, Florida, United States
Advanced Clinical Research of Orlando, Inc.
Winter Garden, Florida, United States
Coeur D'Alene Arthritis Clinic
Coeur d'Alene, Idaho, United States
Institute of Arthritis Research
Idaho Falls, Idaho, United States
Deerbrook Medical Associates
Vernon Hills, Illinois, United States
Diagnostic Rheumatology and Research PC
Indianapolis, Indiana, United States
Ochsner Clinic Baton Rouge
Baton Rouge, Louisiana, United States
Arthritis and Diabetes Clinic, Inc
Monroe, Louisiana, United States
Arthritis Treatment Center
Frederick, Maryland, United States
Jasper Clinic
Kalamazoo, Michigan, United States
Arthritis and Osteoporosis Treatment and Research Center
Flowood, Mississippi, United States
Clinvest/ A Division of Banyan Group, Inc.
Springfield, Missouri, United States
St. Louis Center For Clinical Research Barbara Caciolo, MD
St Louis, Missouri, United States
Dr. Prem C. Chatpar M.D.,LLC
Plainview, New York, United States
PMG Research of Salisbury, LLC
Salisbury, North Carolina, United States
Rowan Diagnostic Clinic
Salisbury, North Carolina, United States
PMG Research of Wilmington
Wilmington, North Carolina, United States
Trinity Health Center - Medical Arts
Minot, North Dakota, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Altoona Center For Clinical Research
Duncansville, Pennsylvania, United States
Arthritis Group
Philadelphia, Pennsylvania, United States
Low Country Rheumatology, PA
Charleston, South Carolina, United States
West Tennessee Research Institute
Jackson, Tennessee, United States
Accurate Clinical Management, LLC
Baytown, Texas, United States
Arthritis Care And Diagnostic Center, P.A.
Dallas, Texas, United States
Metroplex Clinical Research Center
Dallas, Texas, United States
Accurate Clinical Management, LLC
Houston, Texas, United States
Rheumatology Clinic of Houston, PA
Houston, Texas, United States
Houston Institute For Clinical Research
Houston, Texas, United States
Arthritis & Osteoporosis Associates, LLP
Lubbock, Texas, United States
Southwest Rheumatology Research, LLC.
Mesquite, Texas, United States
Accurate Clinical Research, Inc.
San Antonio, Texas, United States
Arthritis & Osteoporosis Center of South Texas
San Antonio, Texas, United States
Arthritis Northwest, PLLC
Spokane, Washington, United States
Atencion Integral en Reumatologia (AIR)
CABA, Buenos Aires, Argentina
Centro Medico Privado de Reumatologia
San Miguel de Tucumán, Tucumán Province, Argentina
Centro Radiologico Luis Mendez Collado SRL
San Miguel de Tucumán, Tucumán Province, Argentina
Organizacion Medica de Investigacion S.A - OMI
Buenos Aires, , Argentina
CER San Juan, Centro Polivalente de Asistencia e Investigacion Clinica
San Juan, , Argentina
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Pacific Private Clinic
Southport, Queensland, Australia
QML Pathology
Southport, Queensland, Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia
Emeritus Research
Malvern East, Victoria, Australia
RK Will Pty Ltd
Victoria Park, Western Australia, Australia
University Hospital Clinical Center Banja Luka
Banja Luka, Republika Srpska, Bosnia and Herzegovina
University Clinical Center Tuzla
Tuzla, , Bosnia and Herzegovina
UMHAT "Dr. Georgi Stranski" EAD
Pleven, , Bulgaria
MHAT "Kaspela" EOOD
Plovdiv, , Bulgaria
MHAT EUROHOSPITAL Plovdiv
Plovdiv, , Bulgaria
MHAT Akta Medika OOD
Rousse, , Bulgaria
MHAT Ruse AD
Rousse, , Bulgaria
MHAT Shumen AD
Shumen, , Bulgaria
NMTH Tsar Boris Clinic of Internal Diseases
Sofia, , Bulgaria
MHAT Lyulin EAD
Sofia, , Bulgaria
MHAT "Targovishte" AD
Targovisthe, , Bulgaria
Kw Musculoskeletal Research Inc
Kitchener, Ontario, Canada
Centre de Recherche Musculo-Squelettique
Trois-Rivières, Quebec, Canada
Quantum Research Ltda
Puerto Varas, Los Lagos Region, Chile
Quantum Research
Puerto Varas, Los Lagos Region, Chile
Estudios Clinicos Quinta Region Ltda.
Viña del Mar, Región de Valparaíso, Chile
Prosalud
Santiago, Santiago Metropolitan, Chile
Revmacentrum MUDr. Mostera, s.r.o.
Brno - Zidenice, Czech Republic, Czechia
Revmatologie s.r.o.
Brno, , Czechia
Revmatologicka ambulance
Česká Lípa, , Czechia
Vesalion, s.r.o.
Ostrava- Moravska Ostrava, , Czechia
Revmatologie
Prague, , Czechia
Foundation Parnu Hospital
Pärnu, , Estonia
East-Tallinn Central Hospital Ltd
Tallinn, , Estonia
North Estonia Medical Centre Foundation
Tallinn, , Estonia
Bnai Zion Medical Center
Haifa, , Israel
Rambam Health Care Campus
Haifa, , Israel
Hadassah Medical Center
Jerusalem, , Israel
The Chaim Sheba Medical Center
Tel Litwinsky, , Israel
Health Center 4
Riga, , Latvia
ORTO clinic Ltd
Riga, , Latvia
Alytaus District S. Kudirkos Hospital
Alytus, , Lithuania
VAKK "Clinic of Dr. Kilda"
Kaunas, , Lithuania
PI Republican Siauliai Hospital
Šiauliai, , Lithuania
Unidad de Enfermedades Reumaticas y Cronico Degenerativas S. C.
Torreón, Coahuila, Mexico
Centro Integral en Reumatologia, SA de CV
Guadalajara, Jalisco, Mexico
CINTRE, Centro de Investigacion y Tratamiento Reumatologico S.C. Consultorio Medico de Reumatologia
Mexico City, Mexico City, Mexico
Centro de Investigacion de Tratamientos Innovadores de Sinaloa S.C.
Culiacán, Sinaloa, Mexico
Centro de Investigacion en Tratamientos Innovadores de Sinaloa S.C.
Culiacán, Sinaloa, Mexico
Centro Multidisciplinario para el Desarrollo Especializado de la Invetigacion Clinica en Yucatan
Mérida, Yucatán, Mexico
Departamento de Imagen de Hospital Star Medica Merida
Mérida, Yucatán, Mexico
Laboratorio clínico del Hospital Star Medica Merida
Mérida, Yucatán, Mexico
Storage for lab kits and study materials
Mérida, Yucatán, Mexico
Investigacion y Biomedica de Chihuahua, SC
Chihuahua City, , Mexico
Centro de Integral en Reumatologia SA de CV
Jalisco, , Mexico
Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi, S.C.
San Luis Potosí City, , Mexico
Unidad de Investigaciones Reumatologicas A.C.
San Luis Potosí City, , Mexico
Unidad de Investigacion en Medicina Interna y Enfermedades criticas-Hogar Clinica San Juan de Dios
Arequipa, , Peru
ABK REUMAR S.R.L. de Medicentro Biociencias_ BIO CIENCIAS PERU S.R.L.
Lima, , Peru
Instituto Peruano del Hueso y la Articulacion
Lima, , Peru
Investigaciones Clinicas S.A.C.
Lima, , Peru
Mary Mediatrix Medical Center
Lipa City, Batangas, Philippines
Brokenshire Integrated Health Ministries, Inc.
Davao City, Davao DEL SUR, Philippines
Iloilo Doctors' Hospital, Inc
Iloilo City, Iloilo, Philippines
University of the Philippines Manila-Philippine General Hospital
Manila, National Capital Region, Philippines
Jose R. Reyes Memorial Medical Center-Rayuma Klinik
Manila, National Capital Region, Philippines
St. Luke's Medical Center
Quezon City, National Capital Region, Philippines
Far Eastern University - NRMF Medical Center
Quezon City, National Capital Region, Philippines
Perpetual Succour Hospital
Cebu City, , Philippines
Davao Doctors Hospital
Davao City, , Philippines
St. Paul's Hospital of Iloilo, Inc.
Iloilo City, , Philippines
Medica Pro Familia Sp. z o.o. S.K.A. Oddzial Krakow
Krakow, Malopolska, Poland
Centrum Medyczne Amed
Warsaw, WOJ Mazowieckie, Poland
Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy,
Bydgoszcz, , Poland
Centrum Medyczne SILESIANA Sp. z o.o.
Bytom, , Poland
Nzoz Bif-Med
Bytom, , Poland
Centrum Kliniczno-Badawcze J.Brzezicki, B.Gornikiewicz-Brzezicka
Elblag, , Poland
Synexus Polska Sp. z o.o. Oddzial w Gdyni
Gdynia, , Poland
Synexus Polska Sp. z o.o. Oddzial w Katowicach
Katowice, , Poland
Centrum Terapii Wspolczesnej J.M. Jasnorzewska Spolka Komandytowo-Akcyjna
Lodz, , Poland
Lecznica MAK-MED, NZOZ
Nadarzyn, , Poland
Prywatna Praktyka Lekarska
Poznan, , Poland
Synexus Polska Sp. z o.o. Oddzial w Warszawie
Warsaw, , Poland
MTZ Clinical Research Sp. z o.o.
Warsaw, , Poland
Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
Wroclaw, , Poland
Spitalul Clinic Judetean de Urgenta Cluj Napoca Reumatologie
Cluj-Napoca, Cluj, Romania
Covamed Serv SRL
Sfântu Gheorghe, Covasna, Romania
Spitalul Judetean de Urgenta "Dr. Constantin Opris"
Baia Mare, Maramureş, Romania
S.C. Clinica Somesan S.R.L.
Baia Mare, Maramureş, Romania
Ianuli Med Consult SRL, Reumatologie
Bucharest, , Romania
Spitalul Clinic Sf. Maria, Medicina interna - Reumatologie
Bucharest, , Romania
Spitalul Clinic Sf. Maria
Bucharest, , Romania
Spitalul Clinic "Dr. I. Cantacuzino"
Bucharest, , Romania
Centrul Clinic de Boli Reumatismale "Dr. Ion Stoia"
Bucharest, , Romania
Spitalul Clinic Judetean de Urgenta - "Sf.Apostol Andrei" Galati
Galati, , Romania
Spitalul Clinic de Recuperare Iasi
Iași, , Romania
Republic Hospital n.a. V.A. Baranov
Petrozavodsk, Karelia Republic, Russia
State Budgetary Healthcare Institution of Karelia Republic "Republic Hospital n.a. V.A. Baranov"
Petrozavodsk, Karelia Republic, Russia
SAHI of KR "Kemerovo Regional Clinical Hospital"
Kemerovo, , Russia
SBEI HPE First Moscow State Medical University n.a.I.M.Sechenov of MoH of RF based on UCH#1
Moscow, , Russia
CJSC "European Medical Center"
Moscow, , Russia
SBEI HPE Novosibirsk State Medical University of MoH of RF
Novosibirsk, , Russia
State Budgetary Healthcare Institution "Orenburg Regional Clinical Hospital"
Orenburg, , Russia
State Budgetary Institution of Ryazan Region "Regional Clinical Cardiology Dispensary"
Ryazan, , Russia
Limited Liability Company AVA-PETER
Saint Petersburg, , Russia
State Budgetary Institution of Healthcare "Samara Regional Clinical Hospital n.a. V.D. Seredavin"
Samara, , Russia
State Institution of Healthcare "Regional Clinical Hospital"
Saratov, , Russia
Non-state Healthcare Institution "Regional Hospital at Smolensk Station of OJSC "Russian Railways"
Smolensk, , Russia
State Autonomous Healthcare lnstitution of Yarostavl Region
Yaroslavl, , Russia
State Budgetary Healthcare Institution of Yaroslavl Region "Clinical Hospital #3"
Yaroslavl, , Russia
Iatros International
Bloemfontein, Free State, South Africa
LCS Clinical Research Unit
Johannesburg, Gauteng, South Africa
WCR: Wits Clinical Research Charlotte Maxeke Johannesburg Academic Hospital
Johannesburg, Gauteng, South Africa
WCR: Wits Clinical Research
Johannesburg, Gauteng, South Africa
Charlotte Maxeke Johannesburg Academic Hospital
Parktown, Johannesburg, Gauteng, South Africa
Clinical Research Unit, University of Pretoria
Pretoria, Gauteng, South Africa
Netcare Jakaranda Hospital
Pretoria, Gauteng, South Africa
University of Pretoria
Pretoria, Gauteng, South Africa
Netcare St Augustine's Hospital
Durban, KwaZulu-Natal, South Africa
Arthritis Clinical Research Trials
Cape Town, Western Cape, South Africa
Panorama Medical Centre
Cape Town, Western Cape, South Africa
Wineland Medical Research Centre
Stellenbosch, Western Cape, South Africa
Inha University Hospital
Jung-Gu, Incheon, South Korea
Kyungpook National University Hospital
Daegu, , South Korea
Daegu Catholic University Medical Center
Daegu, , South Korea
Chonnam National University Hospital
Gwangju, , South Korea
Hanyang University Seoul Hospital
Seoul, , South Korea
Konkuk University Medical Center
Seoul, , South Korea
Complejo Hospitalario Universitario de Santiago de Compostela, Hospital Clinico Universitario
Santiago de Compostela, A Coruna, Spain
Complexo Hospitalario Universitario A Coruna
A Coruña, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, , Spain
Hospital Regional Universitario de Malaga
Málaga, , Spain
Hospital Infanta Luisa
Seville, , Spain
Chung Shan Medical University Hospital
Taichung, Taiwan ROC, Taiwan
Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Hualien City, , Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital - New
Kaohsiung City, , Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Chang Gung Medical Foundation - Linkou Branch
Taoyuan, , Taiwan
Phramongkutklao Hospital
Bangkok, Rajthevi, Thailand
Cardiology Unit,Department of Medicine, Faculty of Medicine, Ramathibodi Hospital,Mahidol University
Bangkok, , Thailand
Div. of Allergy Immunology and Rheumatology, Dept. of Medicine,
Bangkok, , Thailand
Siriraj Hospital Mahidol University
Bangkok, , Thailand
Songklanagarind Hospital - Prince of Songkhla University
Songkhla, , Thailand
Ankara Universitesi Tip Fakultesi Ibn-i Sina Hastanesi
Ankara, , Turkey (Türkiye)
Ondokuz Mayis Universitesi Tip Fakultesi Saglik Uyg. ve Eg.
Samsun, , Turkey (Türkiye)
Ondokuz Mayis Universitesi Tip Fakultesi Saglik Uygulama ve Egitim Merkezi
Samsun, , Turkey (Türkiye)
Cumhuriyet Universitesi Tip Fakultesi Hastanesi
Sivas, , Turkey (Türkiye)
The Dudley Group NHS Foundation Trust
Dudley, WEST Midlands, United Kingdom
The Royal Wolverhamptons NHS Trust
Cannock, , United Kingdom
The Leeds Teaching Hospitals NHS Trust
Leeds, , United Kingdom
Aintree University Hospital NHS Foundation Trust
Liverpool, , United Kingdom
Royal Free London NHS Foundation Trust
London, , United Kingdom
Countries
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References
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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.
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Other Identifiers
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2014-000358-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ORAL STRATEGY
Identifier Type: OTHER
Identifier Source: secondary_id
A3921187
Identifier Type: -
Identifier Source: org_study_id
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