A Study Comparing 2 Doses Of CP-690,550 Vs. Placebo For The Treatment Of Rheumatoid Arthritis In Patients On Other Background Arthritis Medications
6 dicembre 2012 aggiornato da: Pfizer
Phase 3, Randomized, Double Blind, Placebo Controlled Study Of The Safety And Efficacy Of 2 Doses Of CP 690,550 In Patients With Active Rheumatoid Arthritis On Background DMARDS
This Phase 3 study is intended to provide evidence that CP-690,550 dosed 5 mg BID and 10 mg BID is safe and effective when used in combination with a variety of traditional disease modifying antirheumatic drugs in adult patients with rheumatoid arthritis.
It is intended to confirm the benefits of CP-690,550 in improving signs and symptoms and physical function that were observed in the Phase 2 rheumatoid arthritis studies.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
795
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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New South Wales
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Campsie, New South Wales, Australia, 2194
- Pfizer Investigational Site
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Queensland
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Cairns, Queensland, Australia, 4870
- Pfizer Investigational Site
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Maroochydore, Queensland, Australia, 4558
- Pfizer Investigational Site
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South Australia
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Woodville, South Australia, Australia, 5011
- Pfizer Investigational Site
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Victoria
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Malvern East, Victoria, Australia, 3145
- Pfizer Investigational Site
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Western Australia
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Shenton Park, Western Australia, Australia, 6008
- Pfizer Investigational Site
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Vina del Mar, Chile, 2570017
- Pfizer Investigational Site
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RM
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Santiago, RM, Chile, 7510186
- Pfizer Investigational Site
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Santiago, RM, Chile, 8360156
- Pfizer Investigational Site
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Santiago, RM
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Providencia, Santiago, RM, Chile, 7530206
- Pfizer Investigational Site
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V Region
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Vina del Mar, V Region, Chile, 2570017
- Pfizer Investigational Site
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Beijing, Cina, 100853
- Pfizer Investigational Site
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Beijing, Cina, 100020
- Pfizer Investigational Site
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Beijing, Cina, 100044
- Pfizer Investigational Site
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Shanghai, Cina, 200001
- Pfizer Investigational Site
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Shanghai, Cina, 200433
- Pfizer Investigational Site
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Shanghai, Cina, 200003
- Pfizer Investigational Site
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Tianjin, Cina, 300052
- Pfizer Investigational Site
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Anhui
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Hefei, Anhui, Cina, 230022
- Pfizer Investigational Site
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Hefei, Anhui, Cina, 230001
- Pfizer Investigational Site
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Guangdong
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Guangzhou, Guangdong, Cina, 510630
- Pfizer Investigational Site
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Guangzhou, Guangdong, Cina, 510260
- Pfizer Investigational Site
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Hubei
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Wuhan, Hubei, Cina, 430030
- Pfizer Investigational Site
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Hunan
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Changsha, Hunan, Cina, 410008
- Pfizer Investigational Site
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Jiangsu
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Nanjing, Jiangsu, Cina, 210029
- Pfizer Investigational Site
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Suzhou, Jiangsu, Cina, 215006
- Pfizer Investigational Site
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Shandong
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Jinan, Shandong, Cina, 250012
- Pfizer Investigational Site
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Qingdao, Shandong, Cina, 266011
- Pfizer Investigational Site
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Shanxi
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Xi'an, Shanxi, Cina, 710032
- Pfizer Investigational Site
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Sichuan
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Chengdu, Sichuan, Cina, 610041
- Pfizer Investigational Site
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Zhejiang
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Hangzhou, Zhejiang, Cina, 310009
- Pfizer Investigational Site
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Atlantico
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Barranquilla, Atlantico, Colombia, 0000
- Pfizer Investigational Site
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Cundinamarca
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Bogota, Cundinamarca, Colombia
- Pfizer Investigational Site
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Santander
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Bucaramanga, Santander, Colombia
- Pfizer Investigational Site
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Opatija, Croazia, 51410
- Pfizer Investigational Site
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Zagreb, Croazia, 10000
- Pfizer Investigational Site
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Frederiksberg, Danimarca, 2000
- Pfizer Investigational Site
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Moscow, Federazione Russa, 115093
- Pfizer Investigational Site
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Moscow, Federazione Russa, 115446
- Pfizer Investigational Site
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Petrozavodsk, Federazione Russa, 185019
- Pfizer Investigational Site
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Helsinki, Finlandia, 00120
- Pfizer Investigational Site
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Hyvinkaa, Finlandia, 05800
- Pfizer Investigational Site
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Tampere, Finlandia, 33520
- Pfizer Investigational Site
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Berlin, Germania, 14059
- Pfizer Investigational Site
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Dresden, Germania, 01067
- Pfizer Investigational Site
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Hamburg, Germania, 22081
- Pfizer Investigational Site
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Leipzig, Germania, 04103
- Pfizer Investigational Site
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Nuernberg, Germania, 90429
- Pfizer Investigational Site
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Rheine, Germania, 48431
- Pfizer Investigational Site
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Maroussi Athens, Grecia, 15126
- Pfizer Investigational Site
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Negeri Sembilan
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Seremban, Negeri Sembilan, Malaysia, 70300
- Pfizer Investigational Site
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Selangor
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Batu Caves, Selangor, Malaysia, 68100
- Pfizer Investigational Site
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Subang Jaya, Selangor, Malaysia, 47500
- Pfizer Investigational Site
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Wilayah Persekutuan
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Putrajaya, Wilayah Persekutuan, Malaysia, 62250
- Pfizer Investigational Site
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Coahuila
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Torreon, Coahuila, Messico, 27000
- Pfizer Investigational Site
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Michoacan
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Morelia, Michoacan, Messico, 58249
- Pfizer Investigational Site
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Morelos
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Cuernavaca, Morelos, Messico, 62270
- Pfizer Investigational Site
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Queretaro
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Mexico, Queretaro, Messico, 76178
- Pfizer Investigational Site
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Yucatan
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Merida, Yucatan, Messico, 97000
- Pfizer Investigational Site
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Bialystok, Polonia, 15-337
- Pfizer Investigational Site
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Bialystok, Polonia, 15-461
- Pfizer Investigational Site
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Koscian, Polonia, 64-000
- Pfizer Investigational Site
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Poznan, Polonia, 60-773
- Pfizer Investigational Site
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Torun, Polonia, 87-100
- Pfizer Investigational Site
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Newcastle Upon Tyne, Regno Unito, NE1 4LP
- Pfizer Investigational Site
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Merseyside
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Wirral, Merseyside, Regno Unito, CH49 5PE
- Pfizer Investigational Site
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Staffs
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Cannock, Staffs, Regno Unito, WS11 2XY
- Pfizer Investigational Site
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West Midlands
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Solihull, West Midlands, Regno Unito, B91 2JL
- Pfizer Investigational Site
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Nove Zamky, Slovacchia, 94001
- Pfizer Investigational Site
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Poprad, Slovacchia, 058 01
- Pfizer Investigational Site
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Povazska Bystrica, Slovacchia, 017 01
- Pfizer Investigational Site
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Rimavska Sobota, Slovacchia, 979 01
- Pfizer Investigational Site
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Senica, Slovacchia, 905 01
- Pfizer Investigational Site
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Zilina, Slovacchia, 010 01
- Pfizer Investigational Site
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A Coruña, Spagna, 15006
- Pfizer Investigational Site
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Madrid, Spagna, 28046
- Pfizer Investigational Site
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Malaga, Spagna, 29009
- Pfizer Investigational Site
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Sevilla, Spagna, 41013
- Pfizer Investigational Site
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A Coruña
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Santiago de Compostela, A Coruña, Spagna, 15705
- Pfizer Investigational Site
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Alabama
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Huntsville, Alabama, Stati Uniti, 35801
- Pfizer Investigational Site
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Arkansas
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Jonesboro, Arkansas, Stati Uniti, 72401
- Pfizer Investigational Site
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California
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Palo Alto, California, Stati Uniti, 94304
- Pfizer Investigational Site
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Stanford, California, Stati Uniti, 94305
- Pfizer Investigational Site
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Colorado
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Boulder, Colorado, Stati Uniti, 80304
- Pfizer Investigational Site
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Denver, Colorado, Stati Uniti, 80206
- Pfizer Investigational Site
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Connecticut
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Danbury, Connecticut, Stati Uniti, 06810
- Pfizer Investigational Site
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Hamden, Connecticut, Stati Uniti, 06518
- Pfizer Investigational Site
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Trumbull, Connecticut, Stati Uniti, 06611
- Pfizer Investigational Site
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Florida
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New Port Richey, Florida, Stati Uniti, 34652
- Pfizer Investigational Site
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Ocala, Florida, Stati Uniti, 34474
- Pfizer Investigational Site
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Plantation, Florida, Stati Uniti, 33324
- Pfizer Investigational Site
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Port Richey, Florida, Stati Uniti, 34668
- Pfizer Investigational Site
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Tamarac, Florida, Stati Uniti, 33321
- Pfizer Investigational Site
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Tampa, Florida, Stati Uniti, 33613
- Pfizer Investigational Site
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Georgia
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Decatur, Georgia, Stati Uniti, 30033
- Pfizer Investigational Site
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Marietta, Georgia, Stati Uniti, 30060
- Pfizer Investigational Site
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Illinois
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Maywood, Illinois, Stati Uniti, 60153
- Pfizer Investigational Site
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Oakbrook Terrace, Illinois, Stati Uniti, 60181
- Pfizer Investigational Site
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Rockford, Illinois, Stati Uniti, 61103-3692
- Pfizer Investigational Site
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Springfield, Illinois, Stati Uniti, 62702
- Pfizer Investigational Site
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Springfield, Illinois, Stati Uniti, 62703
- Pfizer Investigational Site
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Vernon Hills, Illinois, Stati Uniti, 60061
- Pfizer Investigational Site
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Indiana
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Evansville, Indiana, Stati Uniti, 47714
- Pfizer Investigational Site
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Indianapolis, Indiana, Stati Uniti, 46227
- Pfizer Investigational Site
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Kansas
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Wichita, Kansas, Stati Uniti, 67203
- Pfizer Investigational Site
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Kentucky
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Lexington, Kentucky, Stati Uniti, 40505
- Pfizer Investigational Site
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Massachusetts
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Leominster, Massachusetts, Stati Uniti, 01453
- Pfizer Investigational Site
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Worcester, Massachusetts, Stati Uniti, 01605
- Pfizer Investigational Site
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Minnesota
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Edina, Minnesota, Stati Uniti, 55435
- Pfizer Investigational Site
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Nebraska
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Lincoln, Nebraska, Stati Uniti, 68516
- Pfizer Investigational Site
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New York
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Albany, New York, Stati Uniti, 12206
- Pfizer Investigational Site
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Orchard Park, New York, Stati Uniti, 14127
- Pfizer Investigational Site
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Rochester, New York, Stati Uniti, 14618
- Pfizer Investigational Site
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North Carolina
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Asheville, North Carolina, Stati Uniti, 28801
- Pfizer Investigational Site
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Charlotte, North Carolina, Stati Uniti, 28210
- Pfizer Investigational Site
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Pennsylvania
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Bethlehem, Pennsylvania, Stati Uniti, 18015
- Pfizer Investigational Site
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Wyomissing, Pennsylvania, Stati Uniti, 19610
- Pfizer Investigational Site
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South Carolina
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Greenville, South Carolina, Stati Uniti, 29601
- Pfizer Investigational Site
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Tennessee
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Knoxville, Tennessee, Stati Uniti, 37909
- Pfizer Investigational Site
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Texas
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Austin, Texas, Stati Uniti, 78705
- Pfizer Investigational Site
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Dallas, Texas, Stati Uniti, 75235
- Pfizer Investigational Site
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Washington
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Seattle, Washington, Stati Uniti, 98133
- Pfizer Investigational Site
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Tacoma, Washington, Stati Uniti, 98405
- Pfizer Investigational Site
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Tacoma, Washington, Stati Uniti, 98405-2308
- Pfizer Investigational Site
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West Virginia
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Clarksburg, West Virginia, Stati Uniti, 26301
- Pfizer Investigational Site
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Falun, Svezia, 791 82
- Pfizer Investigational Site
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Goteborg, Svezia, 413 46
- Pfizer Investigational Site
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Uppsala, Svezia, 751 85
- Pfizer Investigational Site
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Bangkok
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Rajathevee, Bangkok, Tailandia, 10400
- Pfizer Investigational Site
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Chiang Mai
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Amphoe Muang, Chiang Mai, Tailandia, 50200
- Pfizer Investigational Site
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Khonkaen
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Muang District, Khonkaen, Tailandia, 40002
- Pfizer Investigational Site
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DC/ Municipio Libertados
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Caracas, DC/ Municipio Libertados, Venezuela, 1040-A
- Pfizer Investigational Site
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Distrito Capital
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Caracas, Distrito Capital, Venezuela, 1010
- Pfizer Investigational Site
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- The patient has a diagnosis of Rheumatoid Arthritis based on the American College of Rheumatology (ACR) 1987 Revised Criteria.
- The patient has active disease as defined by both >=4 tender or painful joints on motion and >= 4 joints swollen; and either an erythrocyte sedimentation rate (ESR) > 28 mm or a C-reactive protein (CRP) concentration > 7 mg/dL.
- Patient had an inadequate response to at least one disease modifying antirheumatic drug (traditional or biologic) due to lack of efficacy or toxicity.
- Patient must remain on at least one background traditional disease modifying antirheumatic drug.
- No evidence of inadequately treated latent or active infection with Mycobacterium tuberculosis.
Exclusion Criteria:
- Blood dyscrasias including confirmed: Hemoglobin <9 g/dL or Hematocrit <30%; White blood cell count <3.0 x 109/L; Absolute neutrophil count <1.2 x 109/L; Platelet count <100 x 109/L.
- 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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Attivo 10 mg
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Film coated tablet, 5 mg PO BID, 1 year
Film coated tablet, 10 mg PO BID, 1 year
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Sperimentale: Active 5 mg
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Film coated tablet, 5 mg PO BID, 1 year
Film coated tablet, 10 mg PO BID, 1 year
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Comparatore placebo: Placebo Sequence 1
Placebo non-responders advance to 5 mg CP-690,550 at Month 3 visit.
All patients in this treatment arm advance to 5 mg CP-690,550 at Month 6 visit.
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Film coated tablet, 1 tablet PO BID, 3-6 months
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Comparatore placebo: Placebo Sequence 2
Placebo non-responders advance to 10 mg CP-690,550 at Month 3 visit.
All patients in this treatment arm advance to 10 mg CP-690,550 at Month 6 visit.
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Film coated tablet, 1 tablet PO BID, 3-6 months
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Variazione rispetto al basale nel punteggio HAQ-DI (Health Assessment Questionnaire-Disability Index) al mese 3
Lasso di tempo: Riferimento, mese 3
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HAQ-DI: valutazione riferita dai partecipanti della capacità di eseguire compiti in 8 categorie di attività della vita quotidiana: vestirsi/spogliarsi; alzarsi; mangiare; camminare; raggiungere; afferrare; igiene; attività comuni nell'ultima settimana.
Ogni elemento ha ottenuto un punteggio su una scala a 4 punti da 0-3:0=nessuna difficoltà;1=qualche difficoltà;2=molto difficile;3=impossibile.
Il punteggio complessivo è stato calcolato come somma dei punteggi dei domini e diviso per il numero di domini con risposta.
Intervallo di punteggio totale possibile 0-3:0=difficoltà minima e 3=difficoltà estrema.
Per il confronto di CP-690.550 con il placebo, le sequenze del placebo sono state combinate in un unico gruppo di segnalazione per l'analisi del mese 3.
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Riferimento, mese 3
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Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6
Lasso di tempo: Month 6
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ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count (TJC); >= 20% improvement in swollen joint count (SJC); and >= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).
For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.
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Month 6
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Percentage of Participants Achieving Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])Less Than 2.6 at Month 6
Lasso di tempo: Month 6
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DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, erythrocyte sedimentation rate (ESR) (millimeters/hour[mm/hour]) and patient's global assessment (PtGA) of disease activity(participant rated arthritis activity assessment).
Total score range:0-9.4,
higher score=more disease activity.
DAS28-4 (ESR) less than or equal to (<=)3.2 implied low disease activity, greater than (>)3.2 to 5.1 implied moderate to high disease activity, less than (<)2.6=remission.
For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.
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Month 6
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Punteggio di attività della malattia utilizzando la conta a 28 articolazioni e la proteina C-reattiva (3 variabili) (DAS28-3 [CRP]) al mese 9 e 12
Lasso di tempo: Mese 9, 12
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DAS28-3 (CRP) è stato calcolato da SJC e TJC utilizzando il conteggio di 28 articolazioni e CRP (mg/L).
Intervallo di punteggio totale: da 0 a 9,4, il punteggio più alto indicava una maggiore attività della malattia.
DAS28-3 (CRP) =<3,2 implicava una bassa attività della malattia, da >3,2 a 5,1 implicava un'attività della malattia da moderata a elevata e <2,6 implicava la remissione.
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Mese 9, 12
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Valutazione del paziente del dolore da artrite al mese 9 e 12
Lasso di tempo: Mese 9, 12
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I partecipanti hanno valutato la gravità del dolore da artrite su un VAS da 0 a 100 mm, dove 0 mm = nessun dolore e 100 mm = dolore più grave.
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Mese 9, 12
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Numero di eventi, comprese visite, interventi chirurgici, test o dispositivi valutati utilizzando RA-HCRU al basale, mese 3 e 6
Lasso di tempo: Basale, mese 3, 6
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RA-HCRU ha valutato l'utilizzo dell'assistenza sanitaria nei 3 mesi precedenti per i domini dei costi medici diretti o indiretti.
È stato riportato qualsiasi numero di eventi correlati ad AR/non AR, comprese le visite dal medico, il medico non medico, il trattamento ospedaliero di pronto soccorso, i ricoveri, il numero di interventi chirurgici, i test diagnostici e i dispositivi/ausili utilizzati.
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Basale, mese 3, 6
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Numero di eventi, comprese visite, interventi chirurgici, test o dispositivi valutati utilizzando RA-HCRU al mese 12
Lasso di tempo: Mese 12
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RA-HCRU ha valutato l'utilizzo dell'assistenza sanitaria nei 3 mesi precedenti per i domini dei costi medici diretti o indiretti.
È stato riportato qualsiasi numero di eventi correlati ad AR/non AR, comprese le visite dal medico, il medico non medico, il trattamento ospedaliero di pronto soccorso, i ricoveri, il numero di interventi chirurgici, i test diagnostici e i dispositivi/ausili utilizzati.
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Mese 12
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Indagine sulla salute in forma breve a 36 voci (SF-36) al basale, mese 1, 3 e 6
Lasso di tempo: Basale, mese 1, 3, 6
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SF-36 è un'indagine standardizzata che valuta 8 aspetti della salute funzionale e del benessere: funzionamento fisico, ruolo fisico, dolore corporeo, salute generale, vitalità, funzionamento sociale, ruolo emotivo e salute mentale.
Il punteggio per una sezione è una media dei punteggi delle singole domande, che sono scalati da 0 a 100 (100=livello più alto di funzionamento) ed è riportato come 2 punteggi riassuntivi; punteggio della componente fisica e punteggio della componente mentale.
Intervallo di punteggio totale per i punteggi di riepilogo = 0-100, dove il punteggio più alto rappresenta un livello di funzionamento più elevato.
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Basale, mese 1, 3, 6
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Medical Outcomes Study Sleep Scale (MOS-SS) al basale, mese 1, 3 e 6
Lasso di tempo: Basale, mese 1, 3, 6
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Questionario di 12 elementi valutato dai partecipanti per valutare i costrutti del sonno nell'ultima settimana. 7 sottoscale: disturbi del sonno, russamento, mancanza di respiro al risveglio, adeguatezza del sonno, sonnolenza (intervallo: 0-100); quantità di sonno (intervallo: 0-24), sonno ottimale (sì o no).
Le misure dell'indice a 9 elementi dei disturbi del sonno forniscono punteggi compositi: riepilogo dei problemi di sonno, problemi di sonno complessivi.
Ad eccezione di Adeguatezza, Ottimale, Quantità di sonno, punteggi più alti=maggiore menomazione.
Punteggi trasformati (punteggio grezzo effettivo (RS) meno il punteggio più basso possibile diviso per il possibile intervallo RS*100); intervallo di punteggio totale: 0-100, punteggio più alto = maggiore intensità dell'attributo.
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Basale, mese 1, 3, 6
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Numero di partecipanti con un sonno ottimale valutato utilizzando la scala del sonno dello studio dei risultati medici (MOS-SS) al basale, mese 1, 3 e 6
Lasso di tempo: Basale, mese 1, 3, 6
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MOS-SS: questionario di 12 elementi valutato dai partecipanti per valutare i costrutti del sonno nell'ultima settimana.
Comprendeva 7 sottoscale: disturbi del sonno, russamento, mancanza di respiro al risveglio, adeguatezza del sonno, sonnolenza, quantità di sonno e sonno ottimale.
I partecipanti hanno risposto se il loro sonno era ottimale o meno scegliendo sì o no.
Viene riportato il numero di partecipanti con un sonno ottimale.
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Basale, mese 1, 3, 6
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Valutazione funzionale della terapia per malattie croniche (FACIT)-Scala della fatica al basale, mese 1, 3 e 6
Lasso di tempo: Basale, mese 1, 3, 6
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FACIT-Fatigue è un questionario di 13 item.
Il partecipante ha valutato ogni elemento su una scala a 5 punti: da 0 (per niente) a 4 (molto).
Maggiore è la risposta del partecipante alle domande (con l'eccezione di 2 affermate negativamente), maggiore è la fatica.
Per tutte le domande, ad eccezione delle 2 formulate negativamente, il codice è stato invertito ed è stato calcolato un nuovo punteggio pari a 4 meno la risposta del partecipante.
La somma di tutte le risposte ha prodotto il punteggio FACIT-Fatigue per un punteggio totale possibile da 0 (punteggio peggiore) a 52 (punteggio migliore).
Un punteggio più alto rifletteva un miglioramento dello stato di salute del partecipante.
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Basale, mese 1, 3, 6
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Euro Quality of Life (EQ-5D) - Punteggio di utilità del profilo dello stato di salute al basale, mese 3 e 6
Lasso di tempo: Basale, mese 3, 6
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EQ-5D: questionario valutato dai partecipanti per valutare la qualità della vita correlata alla salute in termini di un singolo punteggio di utilità.
Il componente Health State Profile valuta il livello di salute attuale per 5 domini: mobilità, cura di sé, attività abituali, dolore e disagio, ansia e depressione; 1 indica uno stato di salute migliore (nessun problema); 3 indica il peggior stato di salute ("confinato a letto").
La formula di punteggio sviluppata da EuroQol Group assegna un valore di utilità per ogni dominio nel profilo.
Il punteggio viene trasformato e risulta in un intervallo di punteggio totale da -0,594 a 1,000; un punteggio più alto indica uno stato di salute migliore.
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Basale, mese 3, 6
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Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Week 2, Month 1, 2, 3, 4.5 and 6
Lasso di tempo: Week 2, Month 1, 2, 3, 4.5, 6
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ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.
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Week 2, Month 1, 2, 3, 4.5, 6
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Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 9 and 12
Lasso di tempo: Month 9, 12
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ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.
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Month 9, 12
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Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Week 2, Month 1, 2, 3, 4.5 and 6
Lasso di tempo: Week 2, Month 1, 2, 3, 4.5, 6
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ACR50 response: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.
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Week 2, Month 1, 2, 3, 4.5, 6
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Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 9 and 12
Lasso di tempo: Month 9, 12
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ACR50 response: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.
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Month 9, 12
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Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Week 2, Month 1, 2, 3, 4.5 and 6
Lasso di tempo: Week 2, Month 1, 2, 3, 4.5, 6
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ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.
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Week 2, Month 1, 2, 3, 4.5, 6
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Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 9 and 12
Lasso di tempo: Month 9, 12
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ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of HAQ); and CRP.
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Month 9, 12
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Disease Activity Score Using 28-Joint Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6
Lasso di tempo: Week 2, Month 1, 2, 3, 4.5, 6
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DAS28-3 (CRP) was calculated from SJC and TJC using 28 joint count and CRP (mg/L).
Total score range: 0 to 9.4, higher score indicated more disease activity.
DAS28-3 (CRP) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.
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Week 2, Month 1, 2, 3, 4.5, 6
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Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 3 and 6
Lasso di tempo: Baseline, Month 3, 6
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DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity).
Total score range:0 to 9.4, higher score indicated more disease activity.
DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.
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Baseline, Month 3, 6
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Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 12
Lasso di tempo: Month 12
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DAS28-4 (ESR) calculated from SJC and TJC using 28 joint count, ESR (mm/hour) and PGA of disease activity (participant rated arthritis activity assessment with transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity).
Total score range:0 to 9.4, higher score indicated more disease activity.
DAS28-4 (ESR) =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.
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Month 12
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Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])
Lasso di tempo: Baseline, Week 2, Month 1, 2, 3, 4.5, 6, 9, 12
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DAS28-4 (CRP) was calculated from SJC and TJC using the 28 joints count, CRP [mg/L] and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity).
Total score range: 0 to 9.4, higher score indicated more disease activity.
DAS28-4 [CRP] <=3.2 implied low disease activity, DAS28-4 [CRP] >3.2 to 5.1 implied moderate to high disease activity and DAS28 <2.6 implied remission.
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Baseline, Week 2, Month 1, 2, 3, 4.5, 6, 9, 12
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Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])
Lasso di tempo: Baseline, Month 3, 6, 12
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DAS28-3 (ESR) was calculated from the number of SJC and TJC using the 28 joints count and ESR (mm/hr).
Total score range: 0 to 9.4, higher score indicated more disease activity.
DAS28-3 (ESR) <=3.2 implied low disease activity, >3.2 to 5.1 implied moderate to high disease activity and <2.6 implied remission.
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Baseline, Month 3, 6, 12
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Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6
Lasso di tempo: Baseline, Week 2, Month 1, 2, 3, 4.5, 6
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HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week.
Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do.
Overall score was computed as the sum of domain scores and divided by the number of domains answered.
Total possible score range 0-3 where 0=least difficulty and 3=extreme difficulty.
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Baseline, Week 2, Month 1, 2, 3, 4.5, 6
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Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 9 and 12
Lasso di tempo: Month 9, Month 12
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HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week.
Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do.
Overall score was computed as the sum of domain scores and divided by the number of domains answered.
Total possible score range 0-3 where 0=least difficulty and 3=extreme difficulty.
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Month 9, Month 12
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Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6
Lasso di tempo: Baseline, Week 2, Month 1, 2, 3, 4.5, 6
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Participants rated the severity of arthritis pain on a 0 to 100 millimeter (mm) visual analogue scale (VAS), where 0 mm = no pain and 100 mm = most severe pain.
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Baseline, Week 2, Month 1, 2, 3, 4.5, 6
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Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6
Lasso di tempo: Baseline, Week 2, Month 1, 2, 3, 4.5, 6
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Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?"
Participants responded by using a 0 - 100 mm VAS where 0 = very well and 100 = very poorly.
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Baseline, Week 2, Month 1, 2, 3, 4.5, 6
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Patient Global Assessment (PtGA) of Arthritis Pain at Month 9 and 12
Lasso di tempo: Month 9, 12
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Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?"
Participants responded by using a 0 - 100 mm VAS where 0 = very well and 100 = very poorly.
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Month 9, 12
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Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6
Lasso di tempo: Baseline, Week 2, Month 1, 2, 3, 4.5, 6
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Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.
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Baseline, Week 2, Month 1, 2, 3, 4.5, 6
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Physician Global Assessment (PGA) of Arthritis at Month 9 and 12
Lasso di tempo: Month 9, 12
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Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.
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Month 9, 12
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36-Item Short-Form Health Survey (SF-36) at Month 9 and 12
Lasso di tempo: Month 9, 12
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SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health.
The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning) and is reported as 2 summary scores; physical component score and mental component score.
Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.
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Month 9, 12
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Medical Outcome Study (MOS) Sleep Scale at Month 12
Lasso di tempo: Month 12
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Participant-rated 12 item questionnaire to assess constructs of sleep over past week.7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence (range:0-100); sleep quantity(range:0-24), optimal sleep(yes or no).
9 item index measures of sleep disturbance provide composite scores: sleep problem summary, overall sleep problem.
Except Adequacy, Optimal, Quantity of sleep, higher scores=more impairment.
Scores transformed(actual raw score(RS) minus lowest possible score divided by possible RS range*100);total score range:0-100,higher score=more intensity of attribute.
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Month 12
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Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12
Lasso di tempo: Month 12
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MOS-SS: participant-rated 12 item questionnaire to assess constructs of sleep over past week.
It included 7 subscales: sleep disturbance, snoring, awakened short of breath, sleep adequacy, somnolence, sleep quantity and optimal sleep.
Participants responded whether their sleep was optimal or not by choosing yes or no.
Number of participants with optimal sleep are reported.
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Month 12
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Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 12
Lasso di tempo: Month 12
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FACIT-Fatigue is a 13-item questionnaire.
Participant scored each item on a 5-point scale: 0 (Not at all) to 4 (Very much).
The larger the participant's response to the questions (with the exception of 2 negatively stated), the greater the fatigue.
For all questions, except for the 2 negatively stated ones, the code was reversed and a new score was calculated as 4 minus the participant's response.
The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score).
A higher score reflected an improvement in the participant's health status.
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Month 12
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Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Month 12
Lasso di tempo: Month 12
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EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score.
Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed").
Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile.
Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
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Month 12
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Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6
Lasso di tempo: Baseline, Month 3, 6
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WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: time management scale (5-items); physical demands scale (6-item); mental-interpersonal demands Scale (9-items); output demands scale (5-items).
All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time).
Work loss index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0[no loss] to 100[complete loss of work]).
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Baseline, Month 3, 6
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Work Limitations Questionnaire (WLQ) Score at Month 12
Lasso di tempo: Month 12
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WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: time management scale (5-items); physical demands scale (6-item); mental-interpersonal demands scale (9-items); output demands scale (5-items).
All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time).
Work loss index, which represented percentage of lost work over time period relative to a normative population, was derived (total score:0[no loss] to 100[complete loss of work]).
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Month 12
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Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Lasso di tempo: Baseline, Month 3, 6
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Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains.
Direct cost:visit to doctor, non-medical practitioner, nursing home, hospital, surgery, emergency room(ER) treatment, diagnostic tests, over-night stay, home healthcare services, aids/devices used.
Indirect costs associated with functional disability:employment status, willingness to work, work disability due to RA, sick leave,part time work, ability to perform chores, chores done by family/friends/housekeeper.
Assessment was based on 0 to 2-point scale;higher score=higher medical cost.
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Baseline, Month 3, 6
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Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12
Lasso di tempo: Month 12
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Rheumatoid Arthritis (RA)-HCRU assessed healthcare usage during last 3 months for direct, indirect medical cost domains.
Direct cost:visit to doctor,non-medical practitioner,nursing home,hospital,surgery,emergency room(ER) treatment,diagnostic tests, over-night stay,home healthcare services, aids/devices used.
Indirect costs associated with functional disability:employment status,willingness to work,work disability due to RA,sick leave,part time work,ability to perform chores,chores done by family/friends/housekeeper.
Assessment was based on 0 to 2-point scale;higher score=higher medical cost.
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Month 12
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Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Lasso di tempo: Baseline, Month 3, 6
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RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains.Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.
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Baseline, Month 3, 6
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Number of Days as Assessed Using RA-HCRU at Month 12
Lasso di tempo: Month 12
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RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains.Any RA or non-RA related number of days spent in hospital, nursing home, aids/devices used, on sick leave, work per week, performed part time work, performed paid work, chores done by housekeeper and chores done by family/friends.
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Month 12
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Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6
Lasso di tempo: Baseline, Month 3, 6
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RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains.
Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.
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Baseline, Month 3, 6
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Number of Hours Per Day as Assessed RA-HCRU at Month 12
Lasso di tempo: Month 12
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RA-HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains.
Any RA or non-RA related number of hours spent per day for home healthcare services, chores done by housekeeper, chores done by family or friends, work done and work missed were reported.
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Month 12
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Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Lasso di tempo: Baseline, Month 3, 6
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Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.
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Baseline, Month 3, 6
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Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 12
Lasso di tempo: Month 12
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Work performance of participants on number of days bothered was based on a 0 to 10-point scale, where higher score indicated lower work performance.
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Month 12
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Global Assessment of Arthritis
Lasso di tempo: 2 weeks
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Patient global assessment of arthritis: participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?"
Participants responded by using a 0 - 100 mm VAS where 0 = very well and 100 = very poorly.
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2 weeks
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Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Assessment of Arthritis Pain
Lasso di tempo: 2 weeks
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Participants rated the severity of arthritis pain on a 0 to 100 mm VAS, where 0 mm = no pain and 100 mm = most severe pain.
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2 weeks
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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. Erratum In: Dig Dis Sci. 2020 Oct 10;:
- 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.
- 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.
- 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.
- 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.
- Charles-Schoeman C, Burmester G, Nash P, Zerbini CA, Soma K, Kwok K, Hendrikx T, Bananis E, Fleischmann R. Efficacy and safety of tofacitinib following inadequate response to conventional synthetic or biological disease-modifying antirheumatic drugs. Ann Rheum Dis. 2016 Jul;75(7):1293-301. doi: 10.1136/annrheumdis-2014-207178. Epub 2015 Aug 14. Erratum In: Ann Rheum Dis. 2017 Mar;76(3):611.
- 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.
- Bartlett SJ, Bingham CO, van Vollenhoven R, Murray C, Gruben D, Gold DA, Cella D. The impact of tofacitinib on fatigue, sleep, and health-related quality of life in patients with rheumatoid arthritis: a post hoc analysis of data from Phase 3 trials. Arthritis Res Ther. 2022 Apr 5;24(1):83. doi: 10.1186/s13075-022-02724-x.
- 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.
- 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.
- Hall S, Nash P, Rischmueller M, Bossingham D, Bird P, Cook N, Witcombe D, Soma K, Kwok K, Thirunavukkarasu K. Tofacitinib, an Oral Janus Kinase Inhibitor: Pooled Efficacy and Safety Analyses in an Australian Rheumatoid Arthritis Population. Rheumatol Ther. 2018 Dec;5(2):383-401. doi: 10.1007/s40744-018-0118-2. Epub 2018 Jun 11.
- 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.
- Li ZG, Liu Y, Xu HJ, Chen ZW, Bao CD, Gu JR, Zhao DB, An Y, Hwang LJ, Wang L, Kremer J, Wu QZ. Efficacy and Safety of Tofacitinib in Chinese Patients with Rheumatoid Arthritis. Chin Med J (Engl). 2018 Nov 20;131(22):2683-2692. doi: 10.4103/0366-6999.245157.
- Strand V, Kremer JM, Gruben D, Krishnaswami S, Zwillich SH, Wallenstein GV. Tofacitinib in Combination With Conventional Disease-Modifying Antirheumatic Drugs in Patients With Active Rheumatoid Arthritis: Patient-Reported Outcomes From a Phase III Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2017 Apr;69(4):592-598. doi: 10.1002/acr.23004.
- Kremer J, Li ZG, Hall S, Fleischmann R, Genovese M, Martin-Mola E, Isaacs JD, Gruben D, Wallenstein G, Krishnaswami S, Zwillich SH, Koncz T, Riese R, Bradley J. Tofacitinib in combination with nonbiologic disease-modifying antirheumatic drugs in patients with active rheumatoid arthritis: a randomized trial. Ann Intern Med. 2013 Aug 20;159(4):253-61. doi: 10.7326/0003-4819-159-4-201308200-00006.
Collegamenti utili
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 maggio 2009
Completamento primario (Effettivo)
1 gennaio 2011
Completamento dello studio (Effettivo)
1 gennaio 2011
Date di iscrizione allo studio
Primo inviato
3 marzo 2009
Primo inviato che soddisfa i criteri di controllo qualità
3 marzo 2009
Primo Inserito (Stima)
5 marzo 2009
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
10 gennaio 2013
Ultimo aggiornamento inviato che soddisfa i criteri QC
6 dicembre 2012
Ultimo verificato
1 dicembre 2012
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- A3921046
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .