Comparing The Effectiveness And Safety Of 2 Doses Of An Experimental Drug, CP-690,550, To Methotrexate (MTX) In Patients With Rheumatoid Arthritis Who Have Not Previously Received MTX
NCT ID: NCT01039688
Last Updated: 2018-04-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
956 participants
INTERVENTIONAL
2010-01-31
2013-03-31
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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5 mg BID CP-690,550
CP-690,550
Oral tablets administered at a dose of 5 mg BID for 24 months
10 mg BID CP-690,550
CP-690,550
Oral tablets administered at a dose of 10 mg BID for 24 months
methotrexate
Disease-modifying antirheumatic drug
Oral capsules,administered as 10 mg per week for 4 weeks titrated to 15 mg per week for 4 weeks, then titrated to 20 mg week for 24 months
Interventions
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CP-690,550
Oral tablets administered at a dose of 5 mg BID for 24 months
CP-690,550
Oral tablets administered at a dose of 10 mg BID for 24 months
Disease-modifying antirheumatic drug
Oral capsules,administered as 10 mg per week for 4 weeks titrated to 15 mg per week for 4 weeks, then titrated to 20 mg week for 24 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of RA based on the American College of Rheumatology 1987 revised criteria.
* Active disease as defined by both \>=6 tender or painful joints on motion and \>= 6 joints swollen; and either an erythrocyte sedimentation rate (ESR) \> 28 mm or a C-reactive protein (CRP) concentration \> 7 mg/dL
Exclusion Criteria
* History of any other rheumatic autoimmune disease other than Sjogren's syndrome
* No malignancy or history of malignancy
* History of infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the 6 months prior to the first dose of study drug
* No chronic liver disease, recent or active hepatitis or other contraindication to methotrexate therapy
18 Years
99 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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Catalina Pointe Clinical Research, Inc.
Tucson, Arizona, United States
Little Rock Diagnostic Clinic
Little Rock, Arkansas, United States
University of California San Diego Perlman Ambulatory Clinic
La Jolla, California, United States
University of California San Diego Center for Innovative Therapy
La Jolla, California, United States
Keck Hospital of USC, Lower Level Pharmacy
Los Angeles, California, United States
Keck Hospital of USC
Los Angeles, California, United States
USC Keck School of Medicine
Los Angeles, California, United States
University of California Los Angeles (UCLA)
Los Angeles, California, United States
Southeastern Arthritis Center
Gainesville, Florida, United States
Southeastern Imaging and Diagnostics
Gainesville, Florida, United States
Southeastern Integrated Medical, PL dba Florida Medical Research
Gainesville, Florida, United States
Center for Arthritis and Rheumatic Diseases
Miami, Florida, United States
Sarasota Arthritis Research Center
Sarasota, Florida, United States
West Broward Rheumatology Associates, Inc.
Tamarac, Florida, United States
Bernard F. Germain, MD
Tampa, Florida, United States
Burnette & Silverfield, MDS PLC
Tampa, Florida, United States
Diagnostic Rheumatology and Research, PC
Indianapolis, Indiana, United States
Medical Associates Clinic, PC
Dubuque, Iowa, United States
Louisiana State University Health Sciences
New Orleans, Louisiana, United States
The Center for Rheumatology and Bone Research
Wheaton, Maryland, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, United States
Physician Research Collaboration, LLC
Lincoln, Nebraska, United States
The Center for Rheumatology
Albany, New York, United States
AAIR Research Center
Rochester, New York, United States
PMG Research of Hickory, LLC
Hickory, North Carolina, United States
PMG Research of Hickory, LLC
Hickory, North Carolina, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Clinical Research Center of Reading, LLP
Wyomissing, Pennsylvania, United States
Medical University of South Carolina - Rheumatology
Charleston, South Carolina, United States
Medical University of South Carolina Investigational Drug Services
Charleston, South Carolina, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Arthritis Clinic
Jackson, Tennessee, United States
West Tennessee Research Institute
Jackson, Tennessee, United States
Austin Rheumatology Research
Austin, Texas, United States
Metroplex Clinical Research Center
Dallas, Texas, United States
University of North Texas Health Science Center at Fort Worth
Fort Worth, Texas, United States
Investigational Drug Service
Seattle, Washington, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Mountain State Clinical Research
Clarksburg, West Virginia, United States
United Hospital Center (Imaging Only)
Clarksburg, West Virginia, United States
OMI - Organización Médica de Investigación
Buenos Aires, , Argentina
Saint Dennis Medical Group S.A.
Buenos Aires, , Argentina
Consultorios Reumatológicos Pampa
Buenos Aires, , Argentina
Rheumatology Research Unit Sunshine Coast
Maroochydore, Queensland, Australia
The Queen Elizabeth Hospital, Department of Rheumatology
Woodville, South Australia, Australia
Emeritus Research
Malvern East, Victoria, Australia
Universitair Ziekenhuis Gent - Reumatologie
Ghent, , Belgium
CIP - Centro Internacional de Pesquisas
Goiânia, Goiás, Brazil
Clinica de Raios X Nabyh Salum S/S - Clinica Sao Matheus
Goiânia, Goiás, Brazil
Centro de Estudos em Terapias Inovadoras
Curitiba, Paraná, Brazil
Hospital Sao Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, Brazil
CEPIC - Centro Paulista de Investigacao Clinica e Servicos Medicos Ltda
São Paulo, São Paulo, Brazil
CCBR Brasil Centro de Pesquisas e Analises Clinicas Ltda
Rio de Janeiro, , Brazil
Revmatologichno Otdelenie, MBAL - Plovdiv
Plovdiv, , Bulgaria
MBAL-Ruse, AD, IV Terapevtichno i kardiologichno otdelenie
Rousse, , Bulgaria
MBAL na Voennomeditsinska Akademia - Sofia, Klinika po Revmatologia i Kardiologia
Sofia, , Bulgaria
MBAL Sveti Ivan Rilski Sofia; Klinika po Revmatologia
Sofia, , Bulgaria
DKTs "Sveta Anna", Sofia; Konsultativen kabinet po Revmatologia
Sofia, , Bulgaria
MOBAL "D-r Stefan Cherkezov" AD, Revmokardiologichno otdelenie s intenziven sektor
Veliko Tarnovo, , Bulgaria
Rheumatology Research Associates Ltd.
Edmonton, Alberta, Canada
PerCuro Clinical Research Ltd.
Victoria, British Columbia, Canada
Manitoba Clinic
Winnipeg, Manitoba, Canada
Burlington Rheumatology and Osteoporosis Clinic
Burlington, Ontario, Canada
Dr. William G. Bensen Medicine Professional Corporation
Hamilton, Ontario, Canada
Office of Dr. Fernando Bianchi
Hamilton, Ontario, Canada
MAC Research Inc.
Hamilton, Ontario, Canada
KW Musculoskeletal Research Inc.
Kitchener, Ontario, Canada
Rheumatology Research Associates
Ottawa, Ontario, Canada
Niagara Peninsula Arthritis Centre
St. Catharines, Ontario, Canada
Windsor Radiological Associates
Windsor, Ontario, Canada
Clinical Research and Arthritis Centre
Windsor, Ontario, Canada
Consulta Privada Dra. Lucia Ponce
Temuco, Región de la AraucanÃa, Chile
Estudios Clinicos V Region
Viña del Mar, Región de ValparaÃso, Chile
Centro de Estudios Reumatologicos
Santiago, RM, Chile
Consulta Privada Dra. Marta Aliste
Santiago, RM, Chile
Hospital Regional de Rancagua
Rancagua, , Chile
Centro de Reumatologia y Ortopedia
Barranquilla, Atlántico, Colombia
Centro Integral de Reumatologia e Inmunologia CIREI
Bogota, Cundinamarca, Colombia
Servimed E.U
Bucaramanga, Santander Department, Colombia
Centro de ReumatologÃa y Osteoporosis, Cartago
Cartago, , Costa Rica
Hospital Cima San Jose
San José, , Costa Rica
Fakultni nemocnice Brno
Brno, , Czechia
Revmacentrum MUDr. Mostera, s.r.o.
Brno - Zidenice, , Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, , Czechia
Revmatologicka ambulance
Ostrava-Poruba, , Czechia
Revmatologicky ustav
Prague, , Czechia
Revmatologicka ambulance
Prague, , Czechia
Patricia Alvarez Site
Santo Domingo, , Dominican Republic
Privat-Praxis, Rheumatologie (P515)
Aachen, , Germany
Schlosspark-Klinik
Berlin, , Germany
Studienambulanz, Medizinische Klinik 3 Universitaetsklinikum Erlangen
Erlangen, , Germany
Schwerpunktpraxis Rheumatologie FAE Innere Medizin
Halle, , Germany
Schoen Klinik Hamburg-Eilbek, Abt. Rheumatologie und Klin. Immunologie
Hamburg, , Germany
Arztpraxis, Internist - Rheumatologie
Nuremberg, , Germany
Rheumaforschung - Studienambulanz Dr. Wassenberg
Ratingen, , Germany
Schwerpunktpraxis fuer Rheumatologie
Rheine, , Germany
Drug Research Center Kft. Reumatologiai Szakrendeles
Balatonfüred, , Hungary
Revita Reumatologiai Rendelo
Budapest, , Hungary
Synexus Magyarorszag Kft.
Budapest, , Hungary
Mozgasszervi Rehabilitacios Kozpont, Reumatologiai szakrendeles
Mezőkövesd, , Hungary
MAV Korhaz es Rendelointezet
Szolnok, , Hungary
Mahavir Hospital & Research Center
Hyderabad, Andhra Pradesh, India
Department of Rheumatology
Secunderabad, Andhra Pradesh, India
Rheumatic Disease Clinic
Ahmedabad, Gujarat, India
Shirdi Sai Hospital
Bangalore, Karnataka, India
Arthritis Research and Care Foundation
Pune, Maharashtra, India
Jehangir Clinical Development Centre Pvt. Ltd.
Pune, Maharashtra, India
Shalby Hospital
Ahmedabad, , India
Hospital Tuanku Ja'afar
Seremban, Negeri Sembilan, Malaysia
Sunway Medical Centre
Petaling Jaya, Selangor, Malaysia
Sarawak General Hospital
Kuching, , Malaysia
Unidad de Enfermedades Reumaticas y Cronico Degenerativas SC
Torreón, Coahuila, Mexico
Instituto Jaliscience de Investigación ClÃnica SA de CV
Guadalajara, Jalisco, Mexico
Unidad de Investigacion en Enfermedades Cronico Degenerativas
Guadalajara, Jalisco, Mexico
Hospital Universitario Jose Eleuterio Gonzalez
Monterrey, Nuevo León, Mexico
Centre for Clinical Research and Effective Practice (CCREP Middlemore Hospital
Otahuhu, Auckland, New Zealand
The Canterbury Geriatric Medical Research Trust, c/- The Princess Margaret Hospital
Christchurch, , New Zealand
Ryburns Building, Waikato Hospital
Hamilton, , New Zealand
Timaru Hospital, Clinical Trials Unit
Timaru, , New Zealand
Hospital Nacional IV Alberto Sabogal Sologuren
Callao, , Peru
Clinica Anglo Americana
Lima, , Peru
Centro Medico Corpac
Lima, , Peru
Instituto Peruano del Hueso y la Articulacion SAC-Privado-Lima/Centro de Investigacion IPHAR
Lima, , Peru
Chong Hua Hospital
Cebu City, , Philippines
Brokenshire Integrated Health Ministries, Inc. Brokenshire Memorial Hospital
Davao City, , Philippines
Rayuma Klinik, OPD Department, Jose R. Reyes Memorial Medical Center
Manila, , Philippines
Przychodnia Medyczna Lekarskiej Spoldzielni Pracy
Gdynia, , Poland
Centrum Leczenia Chorob Cywilizacyjnych Sp. z.o.o. SKA Oddzial Gdynia
Gdynia, , Poland
Centrum Leczenia Chorob Cywilizacyjnych Sp. z o.o. SKA Oddzial Katowice
Katowice, , Poland
Synexus SCM Sp. z o.o. Oddzial Warszawa
Warsaw, , Poland
Rheuma Medicus - Specjalistyczne Centrum Reumatologii i Osteoporozy
Warsaw, , Poland
Ponce School of Medicine
Ponce, , Puerto Rico
Edificio Parra
Ponce, , Puerto Rico
State Healthcare Institution Regional Clinical Hospital
Barnaul, , Russia
State Healthcare Institution Regional Clinical Hospital for War Veterans
Kemerovo, , Russia
Federal State Institution named after Academician E.N. Meshalkin, Novosibirsk State Research
Novosibirsk, , Russia
Scientific Research Institute of Clinical and Experimental Lymphology of the Siberian Branch of RAMS
Novosibirsk, , Russia
State Health Institution City Hospital # 25, City Rheumatology Center of St. Petersburg
Saint Petersburg, , Russia
Clinical Hospital #122 named after L.G. Sokolov of the Federal Medical-Biological Agency
Saint Petersburg, , Russia
Almazov Federal Heart, Blood and Endocrinology Centre
Saint Petersburg, , Russia
State Healthcare Institution City Hospital # 40 of Administrative Health Resort District
Saint Petersburg, , Russia
St. Petersburg State Institution of Healthcare Consultative-diagnostic Center #85
Saint Petersburg, , Russia
Smolensk State Medical Academy, Clinical Research Centre of Diagnostic Medicine and Drugs
Smolensk, , Russia
Regional State Healthcare Institution of Tomsk Regional Clinical Hospital
Tomsk, , Russia
State Healthcare Institution
Yekaterinburg, , Russia
Ltd. Medical Association "Novaya Bolnitsa" (X-Ray Only)
Yekaterinburg, , Russia
State Educational Institution of Higher Professional Education
Yekaterinburg, , Russia
Reumatolog s.r.o.
Bratislava, , Slovakia
AAGS, s.r.o. , nestatne zdravotnicke zariadenie
Dunajská Streda, , Slovakia
Reumatologicka ambulancia, Ecclesia, s.r.o.
Nové Zámky, , Slovakia
Narodny ustav reumatickych chorob
Piešťany, , Slovakia
Nestatna reumatologicka ambulancia
Žilina, , Slovakia
Seoul National University Hospital, Rheumatology, Internal Medicine
Seoul, , South Korea
Yonsei University College of Medicine, Severance Hospital, Rheumatology, Internal Medicine
Seoul, , South Korea
Asan Medical Center, Rheumatology, Internal Medicine
Seoul, , South Korea
Hospital Nuestra Señora de La Esperanza
Santiago de Compostela, A Coruña, Spain
Hospital de Basurto
Bilbao, Vizcaya, Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Hospital Civil. Hospital Regional Universitario Carlos Haya
Málaga, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Skanes Universitetssjukhus i Malmo
Malmo, , Sweden
Sundsvalls sjukhus- Medicinkliniken
Sundsvall, , Sweden
Akademiska sjukhuset, Reumatologmottagningen
Uppsala, , Sweden
Chung-Ho Memorial Hospital, Kaohsiung Medical University
Kaohsiung City, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
Rheumatology Unit, Department of Internal Medicine, Phramongkutklao Hospital
Phayathai, Bangkok, Thailand
Rheumatology Unit, Department of Internal Medicine, Rajavithi Hospital
Bangkok, , Thailand
Siriraj Hospital, Mahidol University
Bangkok, , Thailand
CRI "Clinical Territorial Medical Association "University Clinic", Department of Rheumatology
Simferopol, Autonomous Republic of Crimea, Ukraine
State Institution "Republican Clinical Hospital of the Ministry of Health of Ukraine"
Kyiv, , Ukraine
State Institution "Republican Clinical Hospital of the Ministry of Health of Ukraine"
Kyiv, , Ukraine
Municipal City Clinical Hospital #4, Department of Rheumatology
Lviv, , Ukraine
Municipal Establishment "City Clinical Hospital #9 n.a. O.I. Minakov", Department of Rheumatology
Odesa, , Ukraine
Vinnitsa Regional Clinical Hospital n.a. M.I. Pirogov
Vinnitsa, , Ukraine
Countries
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References
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Hetland 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.
Wright GC, Mysler E, Kwok K, Cadatal MJ, Germino R, Yndestad A, Kinch CD, Ogdie A. Impact of Race on the Efficacy and Safety of Tofacitinib in Rheumatoid Arthritis: Post Hoc Analysis of Pooled Clinical Trials. Rheumatol Ther. 2024 Oct;11(5):1135-1164. doi: 10.1007/s40744-024-00677-y. Epub 2024 Jul 3.
Pope J, Finckh A, Silva-Fernandez L, Mandl P, Fan H, Rivas JL, Valderrama M, Montoro M. Tofacitinib Monotherapy in Rheumatoid Arthritis: Clinical Trials and Real-World Data Contextualization of Patients, Efficacy, and Treatment Retention. Open Access Rheumatol. 2024 Jun 11;16:115-126. doi: 10.2147/OARRR.S446431. eCollection 2024.
Ciurea A, Distler O, Kwok K, Jo H, Wang L, Killeen T, Ospelt C, Frank Bertoncelj M. Joint-level responses to tofacitinib and methotrexate: a post hoc analysis of data from ORAL Start. Arthritis Res Ther. 2023 Sep 29;25(1):185. doi: 10.1186/s13075-023-03144-1.
Charles-Schoeman C, Hyde C, Guan S, Parikh N, Wang J, Shahbazian A, Stockert L, Andrews J. Relationship Between Paraoxonase-1 Genotype and Activity, and Major Adverse Cardiovascular Events and Malignancies in Patients With Rheumatoid Arthritis Receiving Tofacitinib. J Rheumatol. 2023 Jul 15:jrheum.2023-0112. doi: 10.3899/jrheum.2023-0112. Online ahead of print.
Kristensen 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.
Dougados M, Taylor PC, Bingham CO 3rd, Fallon L, Brault Y, Roychoudhury S, Wang L, Kessouri M. The effect of tofacitinib on residual pain in patients with rheumatoid arthritis and psoriatic arthritis. RMD Open. 2022 Sep;8(2):e002478. doi: 10.1136/rmdopen-2022-002478.
Hansen 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.
Curtis 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.
Winthrop KL, Yndestad A, Henrohn D, Danese S, Marsal S, Galindo M, Woolcott JC, Jo H, Kwok K, Shapiro AB, Jones TV, Diehl A, Su C, Panes J, Cohen SB. Influenza Adverse Events in Patients with Rheumatoid Arthritis, Ulcerative Colitis, or Psoriatic Arthritis in the Tofacitinib Clinical Development Programs. Rheumatol Ther. 2023 Apr;10(2):357-373. doi: 10.1007/s40744-022-00507-z. Epub 2022 Dec 17.
Dikranian AH, Gonzalez-Gay MA, Wellborne F, Alvaro-Gracia JM, Takiya L, Stockert L, Paulissen J, Shi H, Tatulych S, Curtis JR. Efficacy of tofacitinib in patients with rheumatoid arthritis stratified by baseline body mass index: an analysis of pooled data from phase 3 studies. RMD Open. 2022 May;8(1):e002103. doi: 10.1136/rmdopen-2021-002103.
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.
Bykerk VP, Lee EB, van Vollenhoven R, Gruben DC, Fallon L, Woolcott JC, Keystone E. Identification of Distinct Disease Activity Trajectories in Methotrexate-Naive Patients With Rheumatoid Arthritis Receiving Tofacitinib Over Twenty-Four Months. Arthritis Care Res (Hoboken). 2022 Jan;74(1):131-141. doi: 10.1002/acr.24709.
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.
Strand V, Kaine J, Alten R, Wallenstein G, Diehl A, Shi H, Germino R, Murray CW. Associations between Patient Global Assessment scores and pain, physical function, and fatigue in rheumatoid arthritis: a post hoc analysis of data from phase 3 trials of tofacitinib. Arthritis Res Ther. 2020 Oct 15;22(1):243. doi: 10.1186/s13075-020-02324-7.
van der Heijde D, Landewe RBM, Wollenhaupt J, Strengholt S, Terry K, Kwok K, Wang L, Cohen S. Assessment of radiographic progression in patients with rheumatoid arthritis treated with tofacitinib in long-term studies. Rheumatology (Oxford). 2021 Apr 6;60(4):1708-1716. doi: 10.1093/rheumatology/keaa476.
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.
Kivitz AJ, Cohen S, Keystone E, van Vollenhoven RF, Haraoui B, Kaine J, Fan H, Connell CA, Bananis E, Takiya L, Fleischmann R. A pooled analysis of the safety of tofacitinib as monotherapy or in combination with background conventional synthetic disease-modifying antirheumatic drugs in a Phase 3 rheumatoid arthritis population. Semin Arthritis Rheum. 2018 Dec;48(3):406-415. doi: 10.1016/j.semarthrit.2018.07.006. Epub 2018 Jul 19.
Strand V, Kavanaugh A, Kivitz AJ, van der Heijde D, Kwok K, Akylbekova E, Soonasra A, Snyder M, Connell C, Bananis E, Smolen JS. Long-Term Radiographic and Patient-Reported Outcomes in Patients with Rheumatoid Arthritis Treated with Tofacitinib: ORAL Start and ORAL Scan Post-hoc Analyses. Rheumatol Ther. 2018 Dec;5(2):341-353. doi: 10.1007/s40744-018-0113-7. Epub 2018 May 14.
van Vollenhoven RF, Lee EB, Fallon L, Zwillich SH, Wilkinson B, Chapman D, DeMasi R, Keystone E. Tofacitinib in Rheumatoid Arthritis: Lack of Early Change in Disease Activity and the Probability of Achieving Low Disease Activity at Month 6. Arthritis Care Res (Hoboken). 2019 Jan;71(1):71-79. doi: 10.1002/acr.23585.
Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, Winthrop KL, Charles-Schoeman C, Thirunavukkarasu K, DeMasi R, Geier J, Kwok K, Wang L, Riese R, Wollenhaupt J. Long-term safety of tofacitinib for the treatment of rheumatoid arthritis up to 8.5 years: integrated analysis of data from the global clinical trials. Ann Rheum Dis. 2017 Jul;76(7):1253-1262. doi: 10.1136/annrheumdis-2016-210457. Epub 2017 Jan 31.
Fleischmann RM, Huizinga TW, Kavanaugh AF, Wilkinson B, Kwok K, DeMasi R, van Vollenhoven RF. Efficacy of tofacitinib monotherapy in methotrexate-naive patients with early or established rheumatoid arthritis. RMD Open. 2016 Jul 26;2(2):e000262. doi: 10.1136/rmdopen-2016-000262. eCollection 2016.
Fleischmann R, Strand V, Wilkinson B, Kwok K, Bananis E. Relationship between clinical and patient-reported outcomes in a phase 3 trial of tofacitinib or MTX in MTX-naive patients with rheumatoid arthritis. RMD Open. 2016 Apr 26;2(1):e000232. doi: 10.1136/rmdopen-2015-000232. eCollection 2016.
Cohen S, Radominski SC, Gomez-Reino JJ, Wang L, Krishnaswami S, Wood SP, Soma K, Nduaka CI, Kwok K, Valdez H, Benda B, Riese R. Analysis of infections and all-cause mortality in phase II, phase III, and long-term extension studies of tofacitinib in patients with rheumatoid arthritis. Arthritis Rheumatol. 2014 Nov;66(11):2924-37. doi: 10.1002/art.38779.
Lee EB, Fleischmann R, Hall S, Wilkinson B, Bradley JD, Gruben D, Koncz T, Krishnaswami S, Wallenstein GV, Zang C, Zwillich SH, van Vollenhoven RF; ORAL Start Investigators. Tofacitinib versus methotrexate in rheumatoid arthritis. N Engl J Med. 2014 Jun 19;370(25):2377-86. doi: 10.1056/NEJMoa1310476.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2009-016987-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
A3921069
Identifier Type: -
Identifier Source: org_study_id
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