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

The Lancet

Volumn 390, Issue 10093, 2017, Pages 457-468

  Fleischmann, Roy ^a   Mysler, Eduardo ^b   Hall, Stephen ^c,h   Kivitz, Alan J ^d,h   Moots, Robert J ^e,h   Luo, Zhen ^f   DeMasi, Ryan ^f   Soma, Koshika ^f   Zhang, Richard ^f   Takiya, Liza ^f   Tatulych, Svitlana ^f   Mojcik, Christopher ^f   Krishnaswami, Sriram ^f   Menon, Sujatha ^f   Smolen, Josef S ^g   Adams, Luthando ^h   Ally, Mahmood M ^h   du Plooy, Maria C ^h   Louw, Ingrid C ^h   Nayiager, Savithree ^h   Nel, Christoffel B ^h   Nel, Debra ^h   Reuter, Helmuth ^h   Soloman, Ahmed S ^h   Spargo, Catherine E ^h   Rischmueller, Maureen ^h   Sharma, Shunil D ^h   Will, Robert K ^h   Youssef, Peter P ^h   Arroyo, Caroline ^h   Baes, Rosario P ^h   Dulos, Roger B ^h   Hao, Llewellyn T ^h   Lanzon, Allan E ^h   Lichauco, Juan Javier T ^h   Mangubat, Jill H ^h   Ramiterre, Edgar B ^h   Reyes, Bernadette Heizel M ^h   Tan, Perry P ^h   Choe, Jung Yoon ^h   Kang, Young Mo ^h   Kwon, Seong Ryul ^h   Lee, Sang Heon ^h   Lee, Shin Seok ^h   Yoo, Dae Hyun ^h   Lin, Hsiao Yi ^h   Luo, Shue Fen ^h   Tsai, Shih Tzu ^h   Tsai, Wen Chan ^h   Tseng, Jui Cheng ^h   Wei, Cheng Chung C ^h   Asavatanabodee, Paijit ^h   Nantiruj, Kanokrat ^h   Nilganuwong, Surasak ^h   Uea Areewongsa, Parichat ^h   Majstorovic, Ljubinka Bozic ^h   Bacic, Suada Mulic ^h   Batalov, Anastas Z ^h   Georgieva Slavcheva, Gabriela ^h   Mihailova, Mariyana ^h   Nikolov, Nikolay G ^h   Penev, Dimitar P ^h   Spasov, Yuliy A ^h   Stanimirova, Krasimira ^h   Todorov, Stoyan ^h   Toncheva, Antoaneta R ^h   Yordanova, Nadezhda ^h   Mosterova, Zdenka ^h   Novosad, Libor ^h   Prochazkova, Leona ^h   Stehlikova, Helena ^h   Stejfova, Zuzana ^h   Kiseleva, Natalia ^h   Pank, Lea ^h   Savi, Triin ^h   Alexandra, Balbir Gurman ^h   Amital, Howard ^h   Mevorach, Dror ^h   Rosner, Itzhak A ^h   Mihailova, Anna ^h   Stumbra Stumberga, Evija ^h   Basijokiene, Vida ^h   Lietuvininkiene, Virginija ^h   Unikiene, Dalia ^h   Brzezicki, Jan ^h   Dudek, Anna M ^h   Glowacka Kulesz, Maria B ^h   Grabowicz Wasko, Barbara ^h   Hajduk Kubacka, Sabina ^h   Hilt, Joanna ^h   Hrycaj, Pawel ^h   Jeka, Slawomir ^h   Kolasa, Renata ^h   Krogulec, Marek ^h   Mastalerz, Hanna ^h   Olak Popko, Anna ^h   Owczarek, Elzbieta ^h   Ruzga, Zofia ^h   Walczak, Alina ^h   Ancuta, Codrina I ^h   Ancuta, Ioan ^h   Balanescu, Andra R ^h   Berghea, Florian ^h   Bojin, Silvia ^h   Arvunescu, Mihaela A Ianuli ^h   Ionescu, Ruxandra M ^h   Mociran, Eugenia ^h   Pavel, Mariana ^h   Rednic, Simona ^h   Voie, Adriana ^h   Zainea, Carmen M ^h   Bugrova, Olga V ^h   Demin, Alexander ^h   Ershova, Olga B ^h   Gavrisheva, Inna A ^h   Krechikova, Diana G ^h   Kuropatkin, Gennady V ^h   Marusenko, Irina M ^h   Menshikova, Irina V ^h   Noskov, Sergey M ^h   Rebrov, Andrey P ^h   Smakotina, Svetlana A ^h   Yakushin, Sergey S ^h   Zhilyaev, Evgeny ^h   Ramos, Juan Jose Amarelo ^h   Garcia, Francisco Javier Blanco ^h   Nebro, Antonio Fernandez ^h   Esteban, Silvia Perez ^h   Burson, Juan Miguel Sanchez ^h   Sala, Raimon Sanmarti ^h   Ataman, Sebnem ^h   Hizmetli, Sami ^h   Kuru, Omer ^h   Douglas, Karen M ^h   Emery, Paul ^h   Ong, Voon H ^h   Sheeran, Thomas P ^h   Faraawi, Rafat Y ^h   Lessard, Clode ^h   Mendoza, Carlos Abud ^h   Avila Armengol, Hilario Ernesto ^h   Zapata, Francisco I Avila ^h   Irazoque Palazuelos, Fedra Consuelo ^h   Cecena, Marco Antonio Maradiaga ^h   Pacheco Tena, Cesar F ^h   Rizo Rodriguez, Juan C ^h   Rodriguez Torres, Isaura M ^h   Aelion, Jacob A ^h   Caciolo, Barbara A ^h   Calmes, James M ^h   Chatpar, Prem ^h   Dayal, Nimesh ^h   De Jesus, Alex ^h   Dikranian, Ara H ^h   Diri, Erdal ^h   Fairfax, Michael J ^h   Fenton, Ira F ^h   Fleischmann, Roy M ^h   Gaylis, Norman B ^h   George, Ronald L ^h   Halter, Dale G ^h   Hernandez, Paul ^h   Hole, Susan A ^h   Hou, Antony C ^h   Huff, John P ^h   Kafaja, Suzanne ^h   Kennedy, Alastair C ^h   Kenney, Howard ^h   Kimmel, Steven C ^h   Kirby, Brian S ^h   Legerton, Clarence W ^h   Lindsey, Stephen M ^h   Mallepalli, Jyothi R ^h   Mathews, Steven D ^h   Metyas, Samy K ^h   Mizutani, Wesley T ^h   Najam, Sabeen ^h   Nascimento, Joao M ^h   Pang, Shirley W ^h   Patel, Rakesh C ^h   Poiley, Jeffrey E ^h   Ramirez, Carlos E ^h   Reddy, Riteesha ^h   Rehman, Qaiser ^h   Schnitz, William M ^h   Scoville, Craig D ^h   Shergy, William J ^h   Silverfield, Joel C ^h   Singhal, Atul K ^h   Smallwood Sherrer, Yvonne R ^h   Songcharoen, Suthin N ^h   Stack, Michael T ^h   Stohl, William ^h   Su, Tien I K ^h   Udell, James ^h   Waraich, Saleem ^h   Weidmann, Charles E ^h   Wei, Nathan ^h   Wiesenhutter, Craig W ^h   Winkler, Anne E ^h   Zagar, Karen E ^h   Berman, Alberto ^h   Mysler, Eduardo F ^h   Hidalgo, Rodolfo A Pardo ^h   Venarotti, Horacio O ^h   Sariego, Irmgadt Annelise Goecke ^h   Calabresse, Renato E Jimenez ^h   Ruiz Tagle, Juan Ignacio Vargas ^h   Vargas, Luis Fernando M Bellatin ^h   Berrocal, Alfredo E ^h   Portocarrero, Manuel Gustavo Leon ^h   Jesus, Felix ^h   Pena, Romero ^h   more..

^a UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER   (United States)

^b Organización Médica de Investigación   (Argentina)

^c MONASH UNIVERSITY   (Australia)

^d Altoona Center for Clinical Research   (United States)

^e UNIVERSITY OF LIVERPOOL   (United Kingdom)

^f PFIZER INC   (United States)

^g MEDICAL UNIVERSITY OF VIENNA   (Austria)

^h NONE

Author keywords

[No Author keywords available]

Indexed keywords

ABATACEPT; ADALIMUMAB; ADENOSINE DEAMINASE; ALANINE AMINOTRANSFERASE; ANAKINRA; ANTIBIOTIC AGENT; ASPARTATE AMINOTRANSFERASE; BILIRUBIN; C REACTIVE PROTEIN; CERTOLIZUMAB PEGOL; CREATININE; ETANERCEPT; GOLIMUMAB; HEMOGLOBIN; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; INFLIXIMAB; ISONIAZID; LOW DENSITY LIPOPROTEIN CHOLESTEROL; METHOTREXATE; PLACEBO; RITUXIMAB; TOCILIZUMAB; TOFACITINIB; VARICELLA ZOSTER VACCINE; ANTIRHEUMATIC AGENT; PIPERIDINE DERIVATIVE; PYRIMIDINE DERIVATIVE; PYRROLE DERIVATIVE;

ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANTIBIOTIC THERAPY; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BACTERIAL INFECTION; BILIRUBIN BLOOD LEVEL; CARDIOPULMONARY ARREST; CHOLESTEROL BLOOD LEVEL; COMPARATIVE EFFECTIVENESS; CONTROLLED STUDY; CREATININE BLOOD LEVEL; DIGESTIVE SYSTEM PERFORATION; DISEASE ACTIVITY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG FATALITY; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG WITHDRAWAL; FEMALE; FEVER; FOLLOW UP; FUNCTIONAL STATUS; HEMOGLOBIN BLOOD LEVEL; HERPES ZOSTER; HUMAN; HYPERTRANSAMINASEMIA; INFLUENZA A (H1N1); INJECTION SITE ERYTHEMA; LIVER FUNCTION TEST; LUNG TUBERCULOSIS; LYMPHOCYTE COUNT; MAJOR CLINICAL STUDY; MALE; MENINGITIS; MIDDLE AGED; MONOTHERAPY; NAUSEA; NEUTROPHIL COUNT; OUTCOME ASSESSMENT; PHASE 3 CLINICAL TRIAL; PHASE 4 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHEUMATOID ARTHRITIS; RHINOPHARYNGITIS; SEPTIC SHOCK; SIDE EFFECT; TOXIC HEPATITIS; UPPER RESPIRATORY TRACT INFECTION; UROSEPSIS; VACCINATION; CLINICAL TRIAL; COMBINATION DRUG THERAPY; COMPARATIVE STUDY; DRUG ADMINISTRATION; MULTICENTER STUDY; ORAL DRUG ADMINISTRATION; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME;

ADALIMUMAB; ADMINISTRATION, ORAL; ADULT; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; DRUG THERAPY, COMBINATION; FEMALE; HUMANS; MALE; METHOTREXATE; MIDDLE AGED; PIPERIDINES; PYRIMIDINES; PYRROLES; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME;

EID: 85020770079     PISSN: 01406736     EISSN: 1474547X     Source Type: Journal    
DOI: 10.1016/S0140-6736(17)31618-5     Document Type: Article

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