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 december 2012 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
795
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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New South Wales
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Campsie, New South Wales, Australië, 2194
- Pfizer Investigational Site
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Queensland
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Cairns, Queensland, Australië, 4870
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Maroochydore, Queensland, Australië, 4558
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South Australia
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Woodville, South Australia, Australië, 5011
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Victoria
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Malvern East, Victoria, Australië, 3145
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Western Australia
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Shenton Park, Western Australia, Australië, 6008
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Vina del Mar, Chili, 2570017
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RM
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Santiago, RM, Chili, 7510186
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Santiago, RM, Chili, 8360156
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Santiago, RM
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Providencia, Santiago, RM, Chili, 7530206
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V Region
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Vina del Mar, V Region, Chili, 2570017
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Beijing, China, 100853
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Beijing, China, 100020
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Beijing, China, 100044
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Shanghai, China, 200001
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Shanghai, China, 200433
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Shanghai, China, 200003
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Tianjin, China, 300052
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Anhui
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Hefei, Anhui, China, 230022
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Hefei, Anhui, China, 230001
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Guangdong
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Guangzhou, Guangdong, China, 510630
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Guangzhou, Guangdong, China, 510260
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Hubei
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Wuhan, Hubei, China, 430030
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Hunan
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Changsha, Hunan, China, 410008
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Jiangsu
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Nanjing, Jiangsu, China, 210029
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Suzhou, Jiangsu, China, 215006
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Shandong
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Jinan, Shandong, China, 250012
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Qingdao, Shandong, China, 266011
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Shanxi
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Xi'an, Shanxi, China, 710032
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Sichuan
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Chengdu, Sichuan, China, 610041
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Zhejiang
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Hangzhou, Zhejiang, China, 310009
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Atlantico
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Barranquilla, Atlantico, Colombia, 0000
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Cundinamarca
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Bogota, Cundinamarca, Colombia
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Santander
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Bucaramanga, Santander, Colombia
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Frederiksberg, Denemarken, 2000
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Berlin, Duitsland, 14059
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Dresden, Duitsland, 01067
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Hamburg, Duitsland, 22081
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Leipzig, Duitsland, 04103
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Nuernberg, Duitsland, 90429
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Rheine, Duitsland, 48431
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Helsinki, Finland, 00120
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Hyvinkaa, Finland, 05800
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Tampere, Finland, 33520
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Maroussi Athens, Griekenland, 15126
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Opatija, Kroatië, 51410
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Zagreb, Kroatië, 10000
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Negeri Sembilan
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Seremban, Negeri Sembilan, Maleisië, 70300
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Selangor
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Batu Caves, Selangor, Maleisië, 68100
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Subang Jaya, Selangor, Maleisië, 47500
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Wilayah Persekutuan
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Putrajaya, Wilayah Persekutuan, Maleisië, 62250
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Coahuila
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Torreon, Coahuila, Mexico, 27000
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Michoacan
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Morelia, Michoacan, Mexico, 58249
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Morelos
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Cuernavaca, Morelos, Mexico, 62270
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Queretaro
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Mexico, Queretaro, Mexico, 76178
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Yucatan
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Merida, Yucatan, Mexico, 97000
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Bialystok, Polen, 15-337
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Bialystok, Polen, 15-461
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Koscian, Polen, 64-000
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Poznan, Polen, 60-773
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Torun, Polen, 87-100
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Moscow, Russische Federatie, 115093
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Moscow, Russische Federatie, 115446
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Petrozavodsk, Russische Federatie, 185019
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Nove Zamky, Slowakije, 94001
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Poprad, Slowakije, 058 01
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Povazska Bystrica, Slowakije, 017 01
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Rimavska Sobota, Slowakije, 979 01
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Senica, Slowakije, 905 01
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Zilina, Slowakije, 010 01
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A Coruña, Spanje, 15006
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Madrid, Spanje, 28046
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Malaga, Spanje, 29009
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Sevilla, Spanje, 41013
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A Coruña
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Santiago de Compostela, A Coruña, Spanje, 15705
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Bangkok
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Rajathevee, Bangkok, Thailand, 10400
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Chiang Mai
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Amphoe Muang, Chiang Mai, Thailand, 50200
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Khonkaen
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Muang District, Khonkaen, Thailand, 40002
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DC/ Municipio Libertados
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Caracas, DC/ Municipio Libertados, Venezuela, 1040-A
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Distrito Capital
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Caracas, Distrito Capital, Venezuela, 1010
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Newcastle Upon Tyne, Verenigd Koninkrijk, NE1 4LP
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Merseyside
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Wirral, Merseyside, Verenigd Koninkrijk, CH49 5PE
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Staffs
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Cannock, Staffs, Verenigd Koninkrijk, WS11 2XY
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West Midlands
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Solihull, West Midlands, Verenigd Koninkrijk, B91 2JL
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Alabama
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Huntsville, Alabama, Verenigde Staten, 35801
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Arkansas
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Jonesboro, Arkansas, Verenigde Staten, 72401
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California
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Palo Alto, California, Verenigde Staten, 94304
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Stanford, California, Verenigde Staten, 94305
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Colorado
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Boulder, Colorado, Verenigde Staten, 80304
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Denver, Colorado, Verenigde Staten, 80206
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Connecticut
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Danbury, Connecticut, Verenigde Staten, 06810
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Hamden, Connecticut, Verenigde Staten, 06518
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Trumbull, Connecticut, Verenigde Staten, 06611
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Florida
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New Port Richey, Florida, Verenigde Staten, 34652
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Ocala, Florida, Verenigde Staten, 34474
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Plantation, Florida, Verenigde Staten, 33324
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Port Richey, Florida, Verenigde Staten, 34668
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Tamarac, Florida, Verenigde Staten, 33321
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Tampa, Florida, Verenigde Staten, 33613
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Georgia
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Decatur, Georgia, Verenigde Staten, 30033
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Marietta, Georgia, Verenigde Staten, 30060
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Illinois
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Maywood, Illinois, Verenigde Staten, 60153
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Oakbrook Terrace, Illinois, Verenigde Staten, 60181
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Rockford, Illinois, Verenigde Staten, 61103-3692
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Springfield, Illinois, Verenigde Staten, 62702
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Springfield, Illinois, Verenigde Staten, 62703
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Vernon Hills, Illinois, Verenigde Staten, 60061
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Indiana
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Evansville, Indiana, Verenigde Staten, 47714
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Indianapolis, Indiana, Verenigde Staten, 46227
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Kansas
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Wichita, Kansas, Verenigde Staten, 67203
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Kentucky
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Lexington, Kentucky, Verenigde Staten, 40505
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Massachusetts
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Leominster, Massachusetts, Verenigde Staten, 01453
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Worcester, Massachusetts, Verenigde Staten, 01605
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Minnesota
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Edina, Minnesota, Verenigde Staten, 55435
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Nebraska
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Lincoln, Nebraska, Verenigde Staten, 68516
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New York
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Albany, New York, Verenigde Staten, 12206
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Orchard Park, New York, Verenigde Staten, 14127
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Rochester, New York, Verenigde Staten, 14618
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North Carolina
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Asheville, North Carolina, Verenigde Staten, 28801
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Charlotte, North Carolina, Verenigde Staten, 28210
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Pennsylvania
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Bethlehem, Pennsylvania, Verenigde Staten, 18015
- Pfizer Investigational Site
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Wyomissing, Pennsylvania, Verenigde Staten, 19610
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South Carolina
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Greenville, South Carolina, Verenigde Staten, 29601
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Tennessee
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Knoxville, Tennessee, Verenigde Staten, 37909
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Texas
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Austin, Texas, Verenigde Staten, 78705
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Dallas, Texas, Verenigde Staten, 75235
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Washington
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Seattle, Washington, Verenigde Staten, 98133
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Tacoma, Washington, Verenigde Staten, 98405
- Pfizer Investigational Site
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Tacoma, Washington, Verenigde Staten, 98405-2308
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West Virginia
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Clarksburg, West Virginia, Verenigde Staten, 26301
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Falun, Zweden, 791 82
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Goteborg, Zweden, 413 46
- Pfizer Investigational Site
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Uppsala, Zweden, 751 85
- Pfizer Investigational Site
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Actief 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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Experimenteel: 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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Placebo-vergelijker: 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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Placebo-vergelijker: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Verandering ten opzichte van baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score in maand 3
Tijdsspanne: Basislijn, maand 3
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HAQ-DI: door deelnemers gerapporteerde beoordeling van het vermogen om taken uit te voeren in 8 categorieën van dagelijkse activiteiten: aankleden/bruidegom; opstaan; eten; lopen; reiken; grijpen; hygiëne;gemeenschappelijke activiteiten afgelopen week.
Elk item scoorde op een 4-puntsschaal van 0-3:0=geen moeite;1=enige moeite;2=veel moeite;3=niet in staat om te doen.
De totale score werd berekend als de som van de domeinscores en gedeeld door het aantal beantwoorde domeinen.
Totaal mogelijk scorebereik 0-3:0=minste moeilijkheid en 3=extreme moeilijkheid.
Voor vergelijking van CP-690.550 met placebo werden placebosequenties gecombineerd tot een enkele rapportagegroep voor de analyse van maand 3.
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Basislijn, maand 3
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Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6
Tijdsspanne: 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
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Ziekteactiviteitsscore met behulp van 28-gewrichtstelling en C-reactief proteïne (3 variabelen) (DAS28-3 [CRP]) op maand 9 en 12
Tijdsspanne: Maand 9, 12
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DAS28-3 (CRP) werd berekend uit SJC en TJC met behulp van 28 gewrichten en CRP (mg/L).
Totale scorebereik: 0 tot 9,4, een hogere score duidde op meer ziekteactiviteit.
DAS28-3 (CRP) =<3,2 impliciete lage ziekteactiviteit, >3,2 tot 5,1 impliciete matige tot hoge ziekteactiviteit en <2,6 impliciete remissie.
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Maand 9, 12
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Patiëntbeoordeling van artritispijn in maand 9 en 12
Tijdsspanne: Maand 9, 12
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Deelnemers beoordeelden de ernst van artritispijn op een VAS van 0 tot 100 mm, waarbij 0 mm = geen pijn en 100 mm = zeer ernstige pijn.
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Maand 9, 12
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Aantal gebeurtenissen inclusief bezoeken, operaties, tests of apparaten zoals beoordeeld met behulp van RA-HCRU bij baseline, maand 3 en 6
Tijdsspanne: Basislijn, maand 3, 6
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RA-HCRU beoordeelde het zorggebruik gedurende de afgelopen 3 maanden voor directe of indirecte medische kostendomeinen.
Elk RA/niet-RA-gerelateerd aantal gebeurtenissen, waaronder bezoeken aan een arts, niet-medische beoefenaar, ziekenhuis-ER-behandeling, ziekenhuisopnames, aantal operaties, diagnostische tests en gebruikte apparaten/hulpmiddelen werden gerapporteerd.
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Basislijn, maand 3, 6
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Aantal gebeurtenissen inclusief bezoeken, operaties, tests of apparaten zoals beoordeeld met behulp van RA-HCRU in maand 12
Tijdsspanne: Maand 12
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RA-HCRU beoordeelde het zorggebruik gedurende de afgelopen 3 maanden voor directe of indirecte medische kostendomeinen.
Elk RA/niet-RA-gerelateerd aantal gebeurtenissen, waaronder bezoeken aan een arts, niet-medicus, ziekenhuis-ER-behandeling, ziekenhuisopnames, aantal operaties, diagnostische tests en gebruikte apparaten/hulpmiddelen werden gerapporteerd.
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Maand 12
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Korte gezondheidsenquête met 36 items (SF-36) bij baseline, maand 1, 3 en 6
Tijdsspanne: Basislijn, maand 1, 3, 6
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SF-36 is een gestandaardiseerde enquête die 8 aspecten van functionele gezondheid en welzijn evalueert: fysiek functioneren, rolfysiek, lichamelijke pijn, algemene gezondheid, vitaliteit, sociaal functioneren, rolemotionele en mentale gezondheid.
De score voor een onderdeel is een gemiddelde van de individuele vraagscores, die worden geschaald van 0-100 (100=hoogste niveau van functioneren) en wordt gerapporteerd als 2 samenvattende scores; fysieke componentscore en mentale componentscore.
Totale scorebereik voor de samenvattende scores = 0-100, waarbij een hogere score staat voor een hoger niveau van functioneren.
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Basislijn, maand 1, 3, 6
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Medical Outcomes Study Sleep Scale (MOS-SS) bij baseline, maand 1, 3 en 6
Tijdsspanne: Basislijn, maand 1, 3, 6
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Door deelnemers beoordeelde vragenlijst met 12 items om de slaapconstructies van de afgelopen week te beoordelen. 7 subschalen: slaapstoornissen, snurken, kortademigheid bij wakker worden, voldoende slaap, slaperigheid (bereik: 0-100); slaaphoeveelheid (bereik: 0-24), optimale slaap (ja of nee).
9 itemindexmetingen van slaapverstoring leveren samengestelde scores op: slaapprobleemsamenvatting, algemeen slaapprobleem.
Behalve Adequaatheid, Optimaal, Hoeveelheid slaap, hogere scores = meer beperkingen.
Getransformeerde scores (werkelijke ruwe score (RS) min de laagst mogelijke score gedeeld door het mogelijke RS-bereik*100);totaal scorebereik:0-100,hogere score=meer intensiteit van attribuut.
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Basislijn, maand 1, 3, 6
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Aantal deelnemers met optimale slaap beoordeeld met behulp van Medical Outcomes Study Sleep Scale (MOS-SS) bij baseline, maand 1, 3 en 6
Tijdsspanne: Basislijn, maand 1, 3, 6
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MOS-SS: door deelnemers beoordeelde vragenlijst met 12 items om de slaapconstructies van de afgelopen week te beoordelen.
Het omvatte 7 subschalen: slaapverstoring, snurken, kortademig wakker worden, voldoende slaap, slaperigheid, hoeveelheid slaap en optimale slaap.
Deelnemers antwoordden of hun slaap optimaal was of niet door ja of nee te kiezen.
Het aantal deelnemers met optimale slaap wordt gerapporteerd.
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Basislijn, maand 1, 3, 6
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Functionele beoordeling van chronische ziektetherapie (FACIT) - Vermoeidheidsschaal bij baseline, maand 1, 3 en 6
Tijdsspanne: Basislijn, maand 1, 3, 6
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FACIT-vermoeidheid is een vragenlijst met 13 items.
De deelnemer scoorde elk item op een 5-puntsschaal: 0 (helemaal niet) tot 4 (zeer veel).
Hoe groter de respons van de deelnemer op de vragen (met uitzondering van 2 negatief geformuleerd), hoe groter de vermoeidheid.
Voor alle vragen, behalve de 2 negatief geformuleerde vragen, werd de code omgekeerd en werd een nieuwe score berekend als 4 minus het antwoord van de deelnemer.
De som van alle antwoorden resulteerde in de FACIT-vermoeidheidsscore voor een totaal mogelijke score van 0 (slechtste score) tot 52 (betere score).
Een hogere score weerspiegelde een verbetering van de gezondheidstoestand van de deelnemer.
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Basislijn, maand 1, 3, 6
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Euro Quality of Life (EQ-5D) - Health State Profile Utility Score bij baseline, maand 3 en 6
Tijdsspanne: Basislijn, maand 3, 6
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EQ-5D: door deelnemers beoordeelde vragenlijst om gezondheidsgerelateerde kwaliteit van leven te beoordelen in termen van een enkele utiliteitsscore.
De component Health State Profile beoordeelt het niveau van de huidige gezondheid voor 5 domeinen: mobiliteit, zelfzorg, gebruikelijke activiteiten, pijn en ongemak, en angst en depressie; 1 geeft een betere gezondheidstoestand aan (geen problemen); 3 geeft de slechtste gezondheidstoestand aan ("bedlegerig").
De door EuroQol Group ontwikkelde scoreformule kent voor elk domein in het profiel een gebruikswaarde toe.
Score wordt getransformeerd en resulteert in een totaal scorebereik van -0,594 tot 1,000; hogere score duidt op een betere gezondheidstoestand.
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Basislijn, maand 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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])
Tijdsspanne: 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])
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Global Assessment of Arthritis
Tijdsspanne: 2 weeks
|
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.
|
2 weeks
|
|
Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Assessment of Arthritis Pain
Tijdsspanne: 2 weeks
|
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.
|
2 weeks
|
Medewerkers en onderzoekers
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Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 mei 2009
Primaire voltooiing (Werkelijk)
1 januari 2011
Studie voltooiing (Werkelijk)
1 januari 2011
Studieregistratiedata
Eerst ingediend
3 maart 2009
Eerst ingediend dat voldeed aan de QC-criteria
3 maart 2009
Eerst geplaatst (Schatting)
5 maart 2009
Updates van studierecords
Laatste update geplaatst (Schatting)
10 januari 2013
Laatste update ingediend die voldeed aan QC-criteria
6 december 2012
Laatst geverifieerd
1 december 2012
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- A3921046
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