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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 de dezembro de 2012 atualizado por: 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

795

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Alemanha
      • Berlin, Alemanha, 14059
        • Pfizer Investigational Site
      • Dresden, Alemanha, 01067
        • Pfizer Investigational Site
      • Hamburg, Alemanha, 22081
        • Pfizer Investigational Site
      • Leipzig, Alemanha, 04103
        • Pfizer Investigational Site
      • Nuernberg, Alemanha, 90429
        • Pfizer Investigational Site
      • Rheine, Alemanha, 48431
        • Pfizer Investigational Site
  • Austrália
    • New South Wales
      • Campsie, New South Wales, Austrália, 2194
        • Pfizer Investigational Site
    • Queensland
      • Cairns, Queensland, Austrália, 4870
        • Pfizer Investigational Site
      • Maroochydore, Queensland, Austrália, 4558
        • Pfizer Investigational Site
    • South Australia
      • Woodville, South Australia, Austrália, 5011
        • Pfizer Investigational Site
    • Victoria
      • Malvern East, Victoria, Austrália, 3145
        • Pfizer Investigational Site
    • Western Australia
      • Shenton Park, Western Australia, Austrália, 6008
        • Pfizer Investigational Site
  • Chile
      • Vina del Mar, Chile, 2570017
        • Pfizer Investigational Site
    • RM
      • Santiago, RM, Chile, 7510186
        • Pfizer Investigational Site
      • Santiago, RM, Chile, 8360156
        • Pfizer Investigational Site
    • Santiago, RM
      • Providencia, Santiago, RM, Chile, 7530206
        • Pfizer Investigational Site
    • V Region
      • Vina del Mar, V Region, Chile, 2570017
        • Pfizer Investigational Site
  • China
      • Beijing, China, 100853
        • Pfizer Investigational Site
      • Beijing, China, 100020
        • Pfizer Investigational Site
      • Beijing, China, 100044
        • Pfizer Investigational Site
      • Shanghai, China, 200001
        • Pfizer Investigational Site
      • Shanghai, China, 200433
        • Pfizer Investigational Site
      • Shanghai, China, 200003
        • Pfizer Investigational Site
      • Tianjin, China, 300052
        • Pfizer Investigational Site
    • Anhui
      • Hefei, Anhui, China, 230022
        • Pfizer Investigational Site
      • Hefei, Anhui, China, 230001
        • Pfizer Investigational Site
    • Guangdong
      • Guangzhou, Guangdong, China, 510630
        • Pfizer Investigational Site
      • Guangzhou, Guangdong, China, 510260
        • Pfizer Investigational Site
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Pfizer Investigational Site
    • Hunan
      • Changsha, Hunan, China, 410008
        • Pfizer Investigational Site
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Pfizer Investigational Site
      • Suzhou, Jiangsu, China, 215006
        • Pfizer Investigational Site
    • Shandong
      • Jinan, Shandong, China, 250012
        • Pfizer Investigational Site
      • Qingdao, Shandong, China, 266011
        • Pfizer Investigational Site
    • Shanxi
      • Xi'an, Shanxi, China, 710032
        • Pfizer Investigational Site
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Pfizer Investigational Site
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Pfizer Investigational Site
  • Colômbia
    • Atlantico
      • Barranquilla, Atlantico, Colômbia, 0000
        • Pfizer Investigational Site
    • Cundinamarca
      • Bogota, Cundinamarca, Colômbia
        • Pfizer Investigational Site
    • Santander
      • Bucaramanga, Santander, Colômbia
        • Pfizer Investigational Site
  • Croácia
      • Opatija, Croácia, 51410
        • Pfizer Investigational Site
      • Zagreb, Croácia, 10000
        • Pfizer Investigational Site
  • Dinamarca
      • Frederiksberg, Dinamarca, 2000
        • Pfizer Investigational Site
  • Eslováquia
      • Nove Zamky, Eslováquia, 94001
        • Pfizer Investigational Site
      • Poprad, Eslováquia, 058 01
        • Pfizer Investigational Site
      • Povazska Bystrica, Eslováquia, 017 01
        • Pfizer Investigational Site
      • Rimavska Sobota, Eslováquia, 979 01
        • Pfizer Investigational Site
      • Senica, Eslováquia, 905 01
        • Pfizer Investigational Site
      • Zilina, Eslováquia, 010 01
        • Pfizer Investigational Site
  • Espanha
      • A Coruña, Espanha, 15006
        • Pfizer Investigational Site
      • Madrid, Espanha, 28046
        • Pfizer Investigational Site
      • Malaga, Espanha, 29009
        • Pfizer Investigational Site
      • Sevilla, Espanha, 41013
        • Pfizer Investigational Site
    • A Coruña
      • Santiago de Compostela, A Coruña, Espanha, 15705
        • Pfizer Investigational Site
  • Estados Unidos
    • Alabama
      • Huntsville, Alabama, Estados Unidos, 35801
        • Pfizer Investigational Site
    • Arkansas
      • Jonesboro, Arkansas, Estados Unidos, 72401
        • Pfizer Investigational Site
    • California
      • Palo Alto, California, Estados Unidos, 94304
        • Pfizer Investigational Site
      • Stanford, California, Estados Unidos, 94305
        • Pfizer Investigational Site
    • Colorado
      • Boulder, Colorado, Estados Unidos, 80304
        • Pfizer Investigational Site
      • Denver, Colorado, Estados Unidos, 80206
        • Pfizer Investigational Site
    • Connecticut
      • Danbury, Connecticut, Estados Unidos, 06810
        • Pfizer Investigational Site
      • Hamden, Connecticut, Estados Unidos, 06518
        • Pfizer Investigational Site
      • Trumbull, Connecticut, Estados Unidos, 06611
        • Pfizer Investigational Site
    • Florida
      • New Port Richey, Florida, Estados Unidos, 34652
        • Pfizer Investigational Site
      • Ocala, Florida, Estados Unidos, 34474
        • Pfizer Investigational Site
      • Plantation, Florida, Estados Unidos, 33324
        • Pfizer Investigational Site
      • Port Richey, Florida, Estados Unidos, 34668
        • Pfizer Investigational Site
      • Tamarac, Florida, Estados Unidos, 33321
        • Pfizer Investigational Site
      • Tampa, Florida, Estados Unidos, 33613
        • Pfizer Investigational Site
    • Georgia
      • Decatur, Georgia, Estados Unidos, 30033
        • Pfizer Investigational Site
      • Marietta, Georgia, Estados Unidos, 30060
        • Pfizer Investigational Site
    • Illinois
      • Maywood, Illinois, Estados Unidos, 60153
        • Pfizer Investigational Site
      • Oakbrook Terrace, Illinois, Estados Unidos, 60181
        • Pfizer Investigational Site
      • Rockford, Illinois, Estados Unidos, 61103-3692
        • Pfizer Investigational Site
      • Springfield, Illinois, Estados Unidos, 62702
        • Pfizer Investigational Site
      • Springfield, Illinois, Estados Unidos, 62703
        • Pfizer Investigational Site
      • Vernon Hills, Illinois, Estados Unidos, 60061
        • Pfizer Investigational Site
    • Indiana
      • Evansville, Indiana, Estados Unidos, 47714
        • Pfizer Investigational Site
      • Indianapolis, Indiana, Estados Unidos, 46227
        • Pfizer Investigational Site
    • Kansas
      • Wichita, Kansas, Estados Unidos, 67203
        • Pfizer Investigational Site
    • Kentucky
      • Lexington, Kentucky, Estados Unidos, 40505
        • Pfizer Investigational Site
    • Massachusetts
      • Leominster, Massachusetts, Estados Unidos, 01453
        • Pfizer Investigational Site
      • Worcester, Massachusetts, Estados Unidos, 01605
        • Pfizer Investigational Site
    • Minnesota
      • Edina, Minnesota, Estados Unidos, 55435
        • Pfizer Investigational Site
    • Nebraska
      • Lincoln, Nebraska, Estados Unidos, 68516
        • Pfizer Investigational Site
    • New York
      • Albany, New York, Estados Unidos, 12206
        • Pfizer Investigational Site
      • Orchard Park, New York, Estados Unidos, 14127
        • Pfizer Investigational Site
      • Rochester, New York, Estados Unidos, 14618
        • Pfizer Investigational Site
    • North Carolina
      • Asheville, North Carolina, Estados Unidos, 28801
        • Pfizer Investigational Site
      • Charlotte, North Carolina, Estados Unidos, 28210
        • Pfizer Investigational Site
    • Pennsylvania
      • Bethlehem, Pennsylvania, Estados Unidos, 18015
        • Pfizer Investigational Site
      • Wyomissing, Pennsylvania, Estados Unidos, 19610
        • Pfizer Investigational Site
    • South Carolina
      • Greenville, South Carolina, Estados Unidos, 29601
        • Pfizer Investigational Site
    • Tennessee
      • Knoxville, Tennessee, Estados Unidos, 37909
        • Pfizer Investigational Site
    • Texas
      • Austin, Texas, Estados Unidos, 78705
        • Pfizer Investigational Site
      • Dallas, Texas, Estados Unidos, 75235
        • Pfizer Investigational Site
    • Washington
      • Seattle, Washington, Estados Unidos, 98133
        • Pfizer Investigational Site
      • Tacoma, Washington, Estados Unidos, 98405
        • Pfizer Investigational Site
      • Tacoma, Washington, Estados Unidos, 98405-2308
        • Pfizer Investigational Site
    • West Virginia
      • Clarksburg, West Virginia, Estados Unidos, 26301
        • Pfizer Investigational Site
  • Federação Russa
      • Moscow, Federação Russa, 115093
        • Pfizer Investigational Site
      • Moscow, Federação Russa, 115446
        • Pfizer Investigational Site
      • Petrozavodsk, Federação Russa, 185019
        • Pfizer Investigational Site
  • Finlândia
      • Helsinki, Finlândia, 00120
        • Pfizer Investigational Site
      • Hyvinkaa, Finlândia, 05800
        • Pfizer Investigational Site
      • Tampere, Finlândia, 33520
        • Pfizer Investigational Site
  • Grécia
      • Maroussi Athens, Grécia, 15126
        • Pfizer Investigational Site
  • Malásia
    • Negeri Sembilan
      • Seremban, Negeri Sembilan, Malásia, 70300
        • Pfizer Investigational Site
    • Selangor
      • Batu Caves, Selangor, Malásia, 68100
        • Pfizer Investigational Site
      • Subang Jaya, Selangor, Malásia, 47500
        • Pfizer Investigational Site
    • Wilayah Persekutuan
      • Putrajaya, Wilayah Persekutuan, Malásia, 62250
        • Pfizer Investigational Site
  • México
    • Coahuila
      • Torreon, Coahuila, México, 27000
        • Pfizer Investigational Site
    • Michoacan
      • Morelia, Michoacan, México, 58249
        • Pfizer Investigational Site
    • Morelos
      • Cuernavaca, Morelos, México, 62270
        • Pfizer Investigational Site
    • Queretaro
      • Mexico, Queretaro, México, 76178
        • Pfizer Investigational Site
    • Yucatan
      • Merida, Yucatan, México, 97000
        • Pfizer Investigational Site
  • Polônia
      • Bialystok, Polônia, 15-337
        • Pfizer Investigational Site
      • Bialystok, Polônia, 15-461
        • Pfizer Investigational Site
      • Koscian, Polônia, 64-000
        • Pfizer Investigational Site
      • Poznan, Polônia, 60-773
        • Pfizer Investigational Site
      • Torun, Polônia, 87-100
        • Pfizer Investigational Site
  • Reino Unido
      • Newcastle Upon Tyne, Reino Unido, NE1 4LP
        • Pfizer Investigational Site
    • Merseyside
      • Wirral, Merseyside, Reino Unido, CH49 5PE
        • Pfizer Investigational Site
    • Staffs
      • Cannock, Staffs, Reino Unido, WS11 2XY
        • Pfizer Investigational Site
    • West Midlands
      • Solihull, West Midlands, Reino Unido, B91 2JL
        • Pfizer Investigational Site
  • Suécia
      • Falun, Suécia, 791 82
        • Pfizer Investigational Site
      • Goteborg, Suécia, 413 46
        • Pfizer Investigational Site
      • Uppsala, Suécia, 751 85
        • Pfizer Investigational Site
  • Tailândia
    • Bangkok
      • Rajathevee, Bangkok, Tailândia, 10400
        • Pfizer Investigational Site
    • Chiang Mai
      • Amphoe Muang, Chiang Mai, Tailândia, 50200
        • Pfizer Investigational Site
    • Khonkaen
      • Muang District, Khonkaen, Tailândia, 40002
        • Pfizer Investigational Site
  • Venezuela
    • DC/ Municipio Libertados
      • Caracas, DC/ Municipio Libertados, Venezuela, 1040-A
        • Pfizer Investigational Site
    • Distrito Capital
      • Caracas, Distrito Capital, Venezuela, 1010
        • Pfizer Investigational Site

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Ativo 10 mg
Medicamento: CP-690,550
Film coated tablet, 5 mg PO BID, 1 year
Medicamento: CP-690,550
Film coated tablet, 10 mg PO BID, 1 year
Experimental: Active 5 mg
Medicamento: CP-690,550
Film coated tablet, 5 mg PO BID, 1 year
Medicamento: CP-690,550
Film coated tablet, 10 mg PO BID, 1 year
Comparador de 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.
Medicamento: Placebo
Film coated tablet, 1 tablet PO BID, 3-6 months
Comparador de 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.
Medicamento: Placebo
Film coated tablet, 1 tablet PO BID, 3-6 months

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Mudança da linha de base na pontuação do Questionário de Avaliação de Saúde-Índice de Incapacidade (HAQ-DI) no Mês 3
Prazo: Linha de base, mês 3
HAQ-DI: avaliação relatada pelo participante da capacidade de realizar tarefas em 8 categorias de atividades da vida diária: vestir-se/arrumar-se; levantar-se; comer; andar;alcance;aperto; higiene; atividades comuns na semana passada. Cada item pontuado em escala de 4 pontos de 0-3: 0=nenhuma dificuldade;1=alguma dificuldade;2=muita dificuldade;3=incapaz de fazer. A pontuação geral foi calculada como a soma das pontuações dos domínios e dividida pelo número de domínios respondidos. Faixa de pontuação total possível 0-3:0 = menor dificuldade e 3 = dificuldade extrema. Para comparação de CP-690.550 com placebo, as sequências de placebo foram combinadas em um único grupo de relatórios para análise do Mês 3.
Linha de base, mês 3
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6
Prazo: Month 6
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.
Month 6
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
Prazo: Month 6
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.
Month 6

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Pontuação de atividade da doença usando contagem de 28 articulações e proteína C-reativa (3 variáveis) (DAS28-3 [CRP]) no mês 9 e 12
Prazo: Mês 9, 12
O DAS28-3 (CRP) foi calculado a partir de SJC e TJC usando contagem de 28 articulações e PCR (mg/L). Faixa de pontuação total: 0 a 9,4, pontuação mais alta indica mais atividade da doença. DAS28-3 (PCR) =<3,2 implica baixa atividade da doença, >3,2 a 5,1 implica moderada a alta atividade da doença e <2,6 implica remissão.
Mês 9, 12
Avaliação do paciente da dor da artrite no mês 9 e 12
Prazo: Mês 9, 12
Os participantes classificaram a gravidade da dor da artrite em um VAS de 0 a 100 mm, onde 0 mm = sem dor e 100 mm = dor mais intensa.
Mês 9, 12
Número de eventos, incluindo visitas, cirurgias, testes ou dispositivos avaliados usando RA-HCRU na linha de base, mês 3 e 6
Prazo: Linha de base, Mês 3, 6
O RA-HCRU avaliou o uso de assistência médica durante os 3 meses anteriores para domínios de custos médicos diretos ou indiretos. Qualquer número de eventos relacionados à AR/não AR, incluindo visitas a médicos, profissionais não médicos, tratamento hospitalar de emergência, hospitalizações, número de cirurgias, testes de diagnóstico e dispositivos/auxílios usados ​​foram relatados.
Linha de base, Mês 3, 6
Número de eventos, incluindo visitas, cirurgias, testes ou dispositivos avaliados usando RA-HCRU no mês 12
Prazo: Mês 12
O RA-HCRU avaliou o uso de assistência médica durante os 3 meses anteriores para domínios de custos médicos diretos ou indiretos. Qualquer número de eventos relacionados à AR/não AR, incluindo visitas a médicos, profissionais não médicos, tratamento hospitalar de emergência, hospitalizações, número de cirurgias, testes de diagnóstico e dispositivos/auxílios usados ​​foram relatados.
Mês 12
Pesquisa de saúde de formulário curto de 36 itens (SF-36) na linha de base, mês 1, 3 e 6
Prazo: Linha de base, Mês 1, 3, 6
O SF-36 é uma pesquisa padronizada que avalia 8 aspectos da saúde funcional e bem-estar: função física, função física, dor corporal, saúde geral, vitalidade, função social, função emocional e saúde mental. A pontuação para uma seção é uma média das pontuações das perguntas individuais, que são escaladas de 0 a 100 (100 = nível mais alto de funcionamento) e são relatadas como 2 pontuações resumidas; pontuação do componente físico e pontuação do componente mental. Faixa de pontuação total para as pontuações resumidas = 0-100, em que a pontuação mais alta representa um nível mais alto de funcionamento.
Linha de base, Mês 1, 3, 6
Escala de sono do estudo de resultados médicos (MOS-SS) na linha de base, mês 1, 3 e 6
Prazo: Linha de base, Mês 1, 3, 6
Questionário de 12 itens avaliado pelo participante para avaliar as construções do sono na última semana. 7 subescalas: distúrbio do sono, ronco, falta de ar acordado, adequação do sono, sonolência (intervalo: 0-100); quantidade de sono (intervalo: 0-24), sono ideal (sim ou não). As medidas do índice de 9 itens de distúrbio do sono fornecem pontuações compostas: resumo do problema do sono, problema geral do sono. Exceto Adequação, Ótima, Quantidade de sono, pontuações mais altas = mais comprometimento. Pontuações transformadas (pontuação bruta real (RS) menos a pontuação mais baixa possível dividida pela faixa de RS possível * 100); faixa de pontuação total: 0-100, pontuação mais alta = mais intensidade do atributo.
Linha de base, Mês 1, 3, 6
Número de participantes com sono ideal avaliado usando a Escala de Sono do Estudo de Resultados Médicos (MOS-SS) na linha de base, mês 1, 3 e 6
Prazo: Linha de base, Mês 1, 3, 6
MOS-SS: questionário de 12 itens avaliado pelo participante para avaliar as construções do sono na última semana. Incluiu 7 subescalas: distúrbio do sono, ronco, despertar com falta de ar, adequação do sono, sonolência, quantidade de sono e sono ideal. Os participantes responderam se o sono era ótimo ou não, escolhendo sim ou não. O número de participantes com sono ideal é relatado.
Linha de base, Mês 1, 3, 6
Avaliação Funcional da Terapia de Doenças Crônicas (FACIT) - Escala de Fadiga na Linha de Base, Mês 1, 3 e 6
Prazo: Linha de base, Mês 1, 3, 6
FACIT-Fadiga é um questionário de 13 itens. O participante pontuou cada item em uma escala de 5 pontos: 0 (Nada) a 4 (Muito). Quanto maior a resposta do participante às questões (com exceção de 2 afirmativas negativas), maior será o cansaço. Para todas as questões, exceto para as 2 afirmativas negativas, o código foi invertido e uma nova pontuação foi calculada como 4 menos a resposta do participante. A soma de todas as respostas resultou no escore FACIT-Fadiga para um escore total possível de 0 (pior escore) a 52 (melhor escore). Uma pontuação mais alta refletiu uma melhora no estado de saúde do participante.
Linha de base, Mês 1, 3, 6
Euro Quality of Life (EQ-5D) - Pontuação de utilidade do perfil de estado de saúde na linha de base, mês 3 e 6
Prazo: Linha de base, Mês 3, 6
EQ-5D: questionário avaliado pelo participante para avaliar a qualidade de vida relacionada à saúde em termos de um único escore de utilidade. O componente Health State Profile avalia o nível de saúde atual em 5 domínios: mobilidade, autocuidado, atividades habituais, dor e desconforto e ansiedade e depressão; 1 indica melhor estado de saúde (sem problemas); 3 indica pior estado de saúde ("confinado ao leito"). A fórmula de pontuação desenvolvida pelo EuroQol Group atribui um valor de utilidade para cada domínio no perfil. A pontuação é transformada e resulta em uma faixa de pontuação total de -0,594 a 1,000; maior pontuação indica um melhor estado de saúde.
Linha de base, Mês 3, 6
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Week 2, Month 1, 2, 3, 4.5 and 6
Prazo: Week 2, Month 1, 2, 3, 4.5, 6
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.
Week 2, Month 1, 2, 3, 4.5, 6
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Month 9 and 12
Prazo: Month 9, 12
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.
Month 9, 12
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Week 2, Month 1, 2, 3, 4.5 and 6
Prazo: Week 2, Month 1, 2, 3, 4.5, 6
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.
Week 2, Month 1, 2, 3, 4.5, 6
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) at Month 9 and 12
Prazo: Month 9, 12
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.
Month 9, 12
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Week 2, Month 1, 2, 3, 4.5 and 6
Prazo: Week 2, Month 1, 2, 3, 4.5, 6
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.
Week 2, Month 1, 2, 3, 4.5, 6
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) at Month 9 and 12
Prazo: Month 9, 12
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.
Month 9, 12
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
Prazo: Week 2, Month 1, 2, 3, 4.5, 6
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.
Week 2, Month 1, 2, 3, 4.5, 6
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Baseline, Month 3 and 6
Prazo: Baseline, Month 3, 6
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.
Baseline, Month 3, 6
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Month 12
Prazo: Month 12
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.
Month 12
Disease Activity Score Using 28-Joint Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])
Prazo: Baseline, Week 2, Month 1, 2, 3, 4.5, 6, 9, 12
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.
Baseline, Week 2, Month 1, 2, 3, 4.5, 6, 9, 12
Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 [ESR])
Prazo: Baseline, Month 3, 6, 12
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.
Baseline, Month 3, 6, 12
Health Assessment Questionnaire Disability Index (HAQ-DI) at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6
Prazo: Baseline, Week 2, Month 1, 2, 3, 4.5, 6
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.
Baseline, Week 2, Month 1, 2, 3, 4.5, 6
Health Assessment Questionnaire Disability Index (HAQ-DI) at Month 9 and 12
Prazo: Month 9, Month 12
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.
Month 9, Month 12
Patient Assessment of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6
Prazo: Baseline, Week 2, Month 1, 2, 3, 4.5, 6
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.
Baseline, Week 2, Month 1, 2, 3, 4.5, 6
Patient Global Assessment (PtGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6
Prazo: Baseline, Week 2, Month 1, 2, 3, 4.5, 6
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.
Baseline, Week 2, Month 1, 2, 3, 4.5, 6
Patient Global Assessment (PtGA) of Arthritis Pain at Month 9 and 12
Prazo: Month 9, 12
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.
Month 9, 12
Physician Global Assessment (PGA) of Arthritis Pain at Baseline, Week 2, Month 1, 2, 3, 4.5 and 6
Prazo: Baseline, Week 2, Month 1, 2, 3, 4.5, 6
Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.
Baseline, Week 2, Month 1, 2, 3, 4.5, 6
Physician Global Assessment (PGA) of Arthritis at Month 9 and 12
Prazo: Month 9, 12
Physician Global Assessment of Arthritis was measured on a 0 to 100 mm VAS, where 0 mm = very good and 100 mm = very bad.
Month 9, 12
36-Item Short-Form Health Survey (SF-36) at Month 9 and 12
Prazo: Month 9, 12
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.
Month 9, 12
Medical Outcome Study (MOS) Sleep Scale at Month 12
Prazo: Month 12
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.
Month 12
Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study Sleep Scale (MOS-SS) at Month 12
Prazo: Month 12
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.
Month 12
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale at Month 12
Prazo: Month 12
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.
Month 12
Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Month 12
Prazo: Month 12
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.
Month 12
Work Limitations Questionnaire (WLQ) Score at Baseline, Month 3 and 6
Prazo: Baseline, Month 3, 6
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]).
Baseline, Month 3, 6
Work Limitations Questionnaire (WLQ) Score at Month 12
Prazo: Month 12
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]).
Month 12
Work Productivity and Healthcare Resource Utilization (HCRU) at Baseline, Month 3 and 6
Prazo: Baseline, Month 3, 6
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.
Baseline, Month 3, 6
Work Productivity and Healthcare Resource Utilization (HCRU) at Month 12
Prazo: Month 12
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.
Month 12
Number of Days as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Prazo: Baseline, Month 3, 6
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.
Baseline, Month 3, 6
Number of Days as Assessed Using RA-HCRU at Month 12
Prazo: Month 12
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.
Month 12
Number of Hours Per Day as Assessed RA-HCRU at Baseline, Month 3 and 6
Prazo: Baseline, Month 3, 6
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.
Baseline, Month 3, 6
Number of Hours Per Day as Assessed RA-HCRU at Month 12
Prazo: Month 12
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.
Month 12
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Baseline, Month 3 and 6
Prazo: Baseline, Month 3, 6
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.
Baseline, Month 3, 6
Work Performance in Past 3 Months on Days Bothered as Assessed Using RA-HCRU at Month 12
Prazo: Month 12
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.
Month 12

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Global Assessment of Arthritis
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Pfizer

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Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de maio de 2009

Conclusão Primária (Real)

1 de janeiro de 2011

Conclusão do estudo (Real)

1 de janeiro de 2011

Datas de inscrição no estudo

Enviado pela primeira vez

3 de março de 2009

Enviado pela primeira vez que atendeu aos critérios de CQ

3 de março de 2009

Primeira postagem (Estimativa)

5 de março de 2009

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

10 de janeiro de 2013

Última atualização enviada que atendeu aos critérios de controle de qualidade

6 de dezembro de 2012

Última verificação

1 de dezembro de 2012

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • A3921046

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