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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 diciembre de 2012 actualizado 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

795

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Alemania
      • Berlin, Alemania, 14059
        • Pfizer Investigational Site
      • Dresden, Alemania, 01067
        • Pfizer Investigational Site
      • Hamburg, Alemania, 22081
        • Pfizer Investigational Site
      • Leipzig, Alemania, 04103
        • Pfizer Investigational Site
      • Nuernberg, Alemania, 90429
        • Pfizer Investigational Site
      • Rheine, Alemania, 48431
        • Pfizer Investigational Site
  • Australia
    • New South Wales
      • Campsie, New South Wales, Australia, 2194
        • Pfizer Investigational Site
    • Queensland
      • Cairns, Queensland, Australia, 4870
        • Pfizer Investigational Site
      • Maroochydore, Queensland, Australia, 4558
        • Pfizer Investigational Site
    • South Australia
      • Woodville, South Australia, Australia, 5011
        • Pfizer Investigational Site
    • Victoria
      • Malvern East, Victoria, Australia, 3145
        • Pfizer Investigational Site
    • Western Australia
      • Shenton Park, Western Australia, Australia, 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
  • Colombia
    • Atlantico
      • Barranquilla, Atlantico, Colombia, 0000
        • Pfizer Investigational Site
    • Cundinamarca
      • Bogota, Cundinamarca, Colombia
        • Pfizer Investigational Site
    • Santander
      • Bucaramanga, Santander, Colombia
        • Pfizer Investigational Site
  • Croacia
      • Opatija, Croacia, 51410
        • Pfizer Investigational Site
      • Zagreb, Croacia, 10000
        • Pfizer Investigational Site
  • Dinamarca
      • Frederiksberg, Dinamarca, 2000
        • Pfizer Investigational Site
  • Eslovaquia
      • Nove Zamky, Eslovaquia, 94001
        • Pfizer Investigational Site
      • Poprad, Eslovaquia, 058 01
        • Pfizer Investigational Site
      • Povazska Bystrica, Eslovaquia, 017 01
        • Pfizer Investigational Site
      • Rimavska Sobota, Eslovaquia, 979 01
        • Pfizer Investigational Site
      • Senica, Eslovaquia, 905 01
        • Pfizer Investigational Site
      • Zilina, Eslovaquia, 010 01
        • Pfizer Investigational Site
  • España
      • A Coruña, España, 15006
        • Pfizer Investigational Site
      • Madrid, España, 28046
        • Pfizer Investigational Site
      • Malaga, España, 29009
        • Pfizer Investigational Site
      • Sevilla, España, 41013
        • Pfizer Investigational Site
    • A Coruña
      • Santiago de Compostela, A Coruña, España, 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
  • Federación Rusa
      • Moscow, Federación Rusa, 115093
        • Pfizer Investigational Site
      • Moscow, Federación Rusa, 115446
        • Pfizer Investigational Site
      • Petrozavodsk, Federación Rusa, 185019
        • Pfizer Investigational Site
  • Finlandia
      • Helsinki, Finlandia, 00120
        • Pfizer Investigational Site
      • Hyvinkaa, Finlandia, 05800
        • Pfizer Investigational Site
      • Tampere, Finlandia, 33520
        • Pfizer Investigational Site
  • Grecia
      • Maroussi Athens, Grecia, 15126
        • Pfizer Investigational Site
  • Malasia
    • Negeri Sembilan
      • Seremban, Negeri Sembilan, Malasia, 70300
        • Pfizer Investigational Site
    • Selangor
      • Batu Caves, Selangor, Malasia, 68100
        • Pfizer Investigational Site
      • Subang Jaya, Selangor, Malasia, 47500
        • Pfizer Investigational Site
    • Wilayah Persekutuan
      • Putrajaya, Wilayah Persekutuan, Malasia, 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
  • Polonia
      • Bialystok, Polonia, 15-337
        • Pfizer Investigational Site
      • Bialystok, Polonia, 15-461
        • Pfizer Investigational Site
      • Koscian, Polonia, 64-000
        • Pfizer Investigational Site
      • Poznan, Polonia, 60-773
        • Pfizer Investigational Site
      • Torun, Polonia, 87-100
        • Pfizer Investigational Site
  • Porcelana
      • Beijing, Porcelana, 100853
        • Pfizer Investigational Site
      • Beijing, Porcelana, 100020
        • Pfizer Investigational Site
      • Beijing, Porcelana, 100044
        • Pfizer Investigational Site
      • Shanghai, Porcelana, 200001
        • Pfizer Investigational Site
      • Shanghai, Porcelana, 200433
        • Pfizer Investigational Site
      • Shanghai, Porcelana, 200003
        • Pfizer Investigational Site
      • Tianjin, Porcelana, 300052
        • Pfizer Investigational Site
    • Anhui
      • Hefei, Anhui, Porcelana, 230022
        • Pfizer Investigational Site
      • Hefei, Anhui, Porcelana, 230001
        • Pfizer Investigational Site
    • Guangdong
      • Guangzhou, Guangdong, Porcelana, 510630
        • Pfizer Investigational Site
      • Guangzhou, Guangdong, Porcelana, 510260
        • Pfizer Investigational Site
    • Hubei
      • Wuhan, Hubei, Porcelana, 430030
        • Pfizer Investigational Site
    • Hunan
      • Changsha, Hunan, Porcelana, 410008
        • Pfizer Investigational Site
    • Jiangsu
      • Nanjing, Jiangsu, Porcelana, 210029
        • Pfizer Investigational Site
      • Suzhou, Jiangsu, Porcelana, 215006
        • Pfizer Investigational Site
    • Shandong
      • Jinan, Shandong, Porcelana, 250012
        • Pfizer Investigational Site
      • Qingdao, Shandong, Porcelana, 266011
        • Pfizer Investigational Site
    • Shanxi
      • Xi'an, Shanxi, Porcelana, 710032
        • Pfizer Investigational Site
    • Sichuan
      • Chengdu, Sichuan, Porcelana, 610041
        • Pfizer Investigational Site
    • Zhejiang
      • Hangzhou, Zhejiang, Porcelana, 310009
        • 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
  • Suecia
      • Falun, Suecia, 791 82
        • Pfizer Investigational Site
      • Goteborg, Suecia, 413 46
        • Pfizer Investigational Site
      • Uppsala, Suecia, 751 85
        • Pfizer Investigational Site
  • Tailandia
    • Bangkok
      • Rajathevee, Bangkok, Tailandia, 10400
        • Pfizer Investigational Site
    • Chiang Mai
      • Amphoe Muang, Chiang Mai, Tailandia, 50200
        • Pfizer Investigational Site
    • Khonkaen
      • Muang District, Khonkaen, Tailandia, 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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Activo 10 mg
Droga: CP-690,550
Film coated tablet, 5 mg PO BID, 1 year
Droga: CP-690,550
Film coated tablet, 10 mg PO BID, 1 year
Experimental: Active 5 mg
Droga: CP-690,550
Film coated tablet, 5 mg PO BID, 1 year
Droga: CP-690,550
Film coated tablet, 10 mg PO BID, 1 year
Comparador de placebos: 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.
Droga: Placebo
Film coated tablet, 1 tablet PO BID, 3-6 months
Comparador de placebos: 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.
Droga: Placebo
Film coated tablet, 1 tablet PO BID, 3-6 months

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Cambio desde el inicio en la puntuación del índice de discapacidad del cuestionario de evaluación de la salud (HAQ-DI) en el mes 3
Periodo de tiempo: Línea de base, Mes 3
HAQ-DI: evaluación informada por el participante de la capacidad para realizar tareas en 8 categorías de actividades de la vida diaria: vestirse/asearse; levantarse; comer; caminar;alcanzar;agarrar; higiene; actividades comunes durante la semana pasada. Cada ítem se calificó en una escala de 4 puntos de 0 a 3: 0 = ninguna dificultad; 1 = alguna dificultad; 2 = mucha dificultad; 3 = incapaz de hacerlo. La puntuación general se calculó como la suma de las puntuaciones de los dominios y se dividió por el número de dominios respondidos. Rango de puntaje total posible 0-3: 0 = dificultad mínima y 3 = dificultad extrema. Para la comparación de CP-690,550 con placebo, las secuencias de placebo se combinaron en un solo grupo de informes para el análisis del Mes 3.
Línea de base, Mes 3
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6
Periodo de tiempo: 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
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Puntuación de la actividad de la enfermedad mediante el recuento de 28 articulaciones y la proteína C reactiva (3 variables) (DAS28-3 [PCR]) en los meses 9 y 12
Periodo de tiempo: Mes 9, 12
DAS28-3 (CRP) se calculó a partir de SJC y TJC utilizando el recuento de 28 articulaciones y CRP (mg/L). Rango de puntuación total: 0 a 9,4, una puntuación más alta indica una mayor actividad de la enfermedad. DAS28-3 (CRP) = <3,2 implica actividad baja de la enfermedad, >3,2 a 5,1 implica actividad moderada a alta de la enfermedad y <2,6 implica remisión.
Mes 9, 12
Evaluación del paciente sobre el dolor de la artritis en los meses 9 y 12
Periodo de tiempo: Mes 9, 12
Los participantes calificaron la gravedad del dolor de la artritis en una EVA de 0 a 100 mm, donde 0 mm = sin dolor y 100 mm = dolor más intenso.
Mes 9, 12
Número de eventos que incluyen visitas, cirugías, pruebas o dispositivos evaluados mediante RA-HCRU al inicio, meses 3 y 6
Periodo de tiempo: Línea de base, Mes 3, 6
RA-HCRU evaluó el uso de atención médica durante los 3 meses anteriores para dominios de costos médicos directos o indirectos. Se informó cualquier número de eventos relacionados con AR/no AR, incluidas visitas al médico, a un médico no médico, tratamiento de urgencias hospitalarias, hospitalizaciones, número de cirugías, pruebas de diagnóstico y dispositivos/ayudas utilizadas.
Línea de base, Mes 3, 6
Número de eventos que incluyen visitas, cirugías, pruebas o dispositivos evaluados mediante RA-HCRU en el mes 12
Periodo de tiempo: Mes 12
RA-HCRU evaluó el uso de atención médica durante los 3 meses anteriores para dominios de costos médicos directos o indirectos. Se informó cualquier número de eventos relacionados con la AR/no AR, incluidas visitas al médico, a un médico no médico, tratamiento en la sala de emergencias del hospital, hospitalizaciones, número de cirugías, pruebas de diagnóstico y dispositivos/ayudas utilizadas.
Mes 12
Encuesta de salud de formato corto de 36 ítems (SF-36) al inicio, meses 1, 3 y 6
Periodo de tiempo: Línea de base, mes 1, 3, 6
SF-36 es una encuesta estandarizada que evalúa 8 aspectos de la salud y el bienestar funcional: funcionamiento físico, rol físico, dolor corporal, salud general, vitalidad, funcionamiento social, rol emocional y salud mental. El puntaje de una sección es un promedio de los puntajes de las preguntas individuales, que se escalan de 0 a 100 (100 = nivel más alto de funcionamiento) y se informa como 2 puntajes resumidos; puntuación del componente físico y puntuación del componente mental. Rango de puntuación total para las puntuaciones resumidas = 0-100, donde la puntuación más alta representa un nivel más alto de funcionamiento.
Línea de base, mes 1, 3, 6
Escala de sueño del estudio de resultados médicos (MOS-SS) al inicio, meses 1, 3 y 6
Periodo de tiempo: Línea de base, mes 1, 3, 6
Cuestionario de 12 ítems calificado por el participante para evaluar las construcciones del sueño durante la última semana. cantidad de sueño (rango: 0-24), sueño óptimo (sí o no). Las medidas del índice de 9 ítems de la alteración del sueño proporcionan puntuaciones compuestas: resumen del problema del sueño, problema general del sueño. Excepto Adecuación, Óptimo, Cantidad de sueño, puntajes más altos = más deterioro. Puntuaciones transformadas (puntuación bruta real (RS) menos la puntuación más baja posible dividida por el rango RS posible*100); rango de puntuación total: 0-100, puntuación más alta = más intensidad del atributo.
Línea de base, mes 1, 3, 6
Número de participantes con sueño óptimo evaluados mediante la escala de sueño del estudio de resultados médicos (MOS-SS) al inicio, los meses 1, 3 y 6
Periodo de tiempo: Línea de base, mes 1, 3, 6
MOS-SS: cuestionario de 12 ítems calificado por los participantes para evaluar las construcciones del sueño durante la última semana. Incluía 7 subescalas: alteración del sueño, ronquidos, dificultad para respirar al despertar, adecuación del sueño, somnolencia, cantidad de sueño y sueño óptimo. Los participantes respondieron si su sueño fue óptimo o no eligiendo sí o no. Se informa el número de participantes con sueño óptimo.
Línea de base, mes 1, 3, 6
Evaluación funcional de la terapia de enfermedades crónicas (FACIT): escala de fatiga al inicio, meses 1, 3 y 6
Periodo de tiempo: Línea de base, mes 1, 3, 6
FACIT-Fatigue es un cuestionario de 13 ítems. El participante calificó cada ítem en una escala de 5 puntos: 0 (Nada) a 4 (Mucho). Cuanto mayor sea la respuesta del participante a las preguntas (a excepción de 2 afirmadas negativamente), mayor será la fatiga. Para todas las preguntas, excepto para las 2 negativas, se invirtió el código y se calculó una nueva puntuación de 4 menos la respuesta del participante. La suma de todas las respuestas resultó en la puntuación FACIT-Fatigue para una puntuación total posible de 0 (peor puntuación) a 52 (mejor puntuación). Una puntuación más alta reflejaba una mejora en el estado de salud del participante.
Línea de base, mes 1, 3, 6
Euro Quality of Life (EQ-5D) - Puntaje de utilidad del perfil de estado de salud al inicio, mes 3 y 6
Periodo de tiempo: Línea de base, Mes 3, 6
EQ-5D: cuestionario calificado por el participante para evaluar la calidad de vida relacionada con la salud en términos de una sola puntuación de utilidad. El componente Perfil del estado de salud evalúa el nivel de salud actual en 5 dominios: movilidad, cuidado personal, actividades habituales, dolor y malestar, y ansiedad y depresión; 1 indica mejor estado de salud (sin problemas); 3 indica el peor estado de salud ("encamado"). La fórmula de puntuación desarrollada por EuroQol Group asigna un valor de utilidad a cada dominio del perfil. La puntuación se transforma y da como resultado un rango de puntuación total de -0,594 a 1,000; una puntuación más alta indica un mejor estado de salud.
Línea de base, Mes 3, 6
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) at Week 2, Month 1, 2, 3, 4.5 and 6
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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])
Periodo de tiempo: 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])
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Time to First Greater Than 1 Day Sequential Decrease in Pain From Baseline for Patient Global Assessment of Arthritis
Periodo de tiempo: 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
Periodo de tiempo: 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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Pfizer

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de mayo de 2009

Finalización primaria (Actual)

1 de enero de 2011

Finalización del estudio (Actual)

1 de enero de 2011

Fechas de registro del estudio

Enviado por primera vez

3 de marzo de 2009

Primero enviado que cumplió con los criterios de control de calidad

3 de marzo de 2009

Publicado por primera vez (Estimar)

5 de marzo de 2009

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

10 de enero de 2013

Última actualización enviada que cumplió con los criterios de control de calidad

6 de diciembre de 2012

Última verificación

1 de diciembre de 2012

Más información

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Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • A3921046

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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CROs in Pakistan

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