Open-Label Study Comparing Etanercept to Conventional Disease Modifying Antirheumatic Drug (DMARD) Therapy
11 de dezembro de 2015 atualizado por: Pfizer
A Randomized, Open-label Study In The Latin America Region Comparing The Safety And Efficacy Of Etanercept With Conventional Dmard Therapy In Subjects With Rheumatoid Arthritis.
The purpose of this 2 phased, open-label study is to compare the safety and efficacy of etanercept with conventional Disease Modifying Antirheumatic Drug (DMARD) therapy in Latin American subjects with moderate to severe rheumatoid arthritis over 128 weeks.
Phase 1 is a randomized 24 week treatment period; Phase 2 is an optional open-label 104 week period that allows the investigator to choose continuation with the phase I treatment or the addition, discontinuation or titration of other DMARD therapy already being utilized for the study.
Visão geral do estudo
Status
Concluído
Condições
Tipo de estudo
Intervencional
Inscrição (Real)
429
Estágio
- Fase 4
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
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Buenos Aires, Argentina, 1280
- Hospital Británico
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Buenos Aires, Argentina, 1015
- OMI
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Buenos Aires, Argentina, 1055
- Centro de Investigaciones en Enfermedades Reumaticas
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Buenos Aires, Argentina, 1426
- Atencion Integral en Reumatologia
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Ciudad Autónoma de Buenos Aires, Argentina, C1114AAH
- Investigaciones Reumatológicas y Osteológicas
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Ciudad Autónoma de Buenos Aires, Argentina, C1128AAF
- Centro de Osteopatias Medicas
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Cordoba, Argentina, 5000
- Sanatorio Mayo
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Corrientes, Argentina, 3400
- Hospital Escuela Gral. San Martin
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San Miguel de Tucuman, Argentina, 4000
- Centro Medico Privado de Reumatologia
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Tucuman, Argentina, 4000
- Centro de Investigaciones Reumatológicas
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Buenos Aires
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Capital Federal, Buenos Aires, Argentina, C1425EKF
- Consultorios Especializados en Investigaciones Medicas
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Provinica de San Juan
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San Juan, Provinica de San Juan, Argentina, 5400
- CER San Juan
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Santa Fe
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Rosario, Santa Fe, Argentina, S2000PBJ
- Instituto CAICI
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Region Metropolitana
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Santiago, Region Metropolitana, Chile
- Hospital del Salvador
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Santiago, Region Metropolitana, Chile
- Dr Miranda Private Practice
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Antioquia
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Medellin, Antioquia, Colômbia
- Reumalab
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Atlantico
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Barranquilla, Atlantico, Colômbia
- Centro de Reumatologia y Ortopedia
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Barranquilla, Atlantico, Colômbia
- IPS Centro Integral de Rematología del Caribe S.A.S CIRCARIBE S.A.S Sede 1
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Barranquilla, Atlantico, Colômbia
- IPS Centro Integral de Rematología del Caribe S.A.S CIRCARIBE S.A.S Sede 2
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Cundinamarca
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Bogota, Cundinamarca, Colômbia
- Fundacion Instituto de Reumatologia Fernando Chalem
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Bogota, Cundinamarca, Colômbia, 0000
- Centro Integral de Reumatologia e Inmunologia LTDA
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Bogota, Cundinamarca, Colômbia
- Foqus Ips Ltda
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Bogota, Cundinamarca, Colômbia
- Riesgo de fractura S.A. Clinica de Artritis y Rehabilitacion
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Chia, Cundinamarca, Colômbia
- Preventive Care Ltda
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Santander
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Bucaramanga, Santander, Colômbia
- Centro Medico Carlos Ardila Lulle
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Bucaramanga, Santander, Colômbia
- Servimed EU
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Chihuahua, México, 31000
- Hospital Christus Muguerza del Parque
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Chihuahua, México, 31000
- Centro de Investigación y Biomedicina de Chihuahua
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Chihuahua, México, 31000
- Hospital Christus Mugerza
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Jalisco
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Guadajara, Jalisco, México, 45040
- Hospital Angeles Chapalita
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Yucatan
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Merida, Yucatan, México
- Centro de Especialidades Medicas del Sureste SA de CV
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Panama, Panamá
- Centro de Infusion Marbella
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Panama, Panamá
- Centro de Investigacion Marbella
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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 a 69 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Diagnosis of Rheumatoid Arthritis (RA)
- Currently receiving a suboptimal response to a stable dose of methotrexate for treatment of Rheumatoid Arthritis (RA)
- Active Rheumatoid Arthritis (RA) at time of screening and baseline
Exclusion Criteria:
- Previous or current treatment with etanercept, other tumor necrosis factor-alpha inhibitors, or other biologic agents
- Concurrent treatment with a Disease Modifying Antirheumatic Drug (DMARD), other than methotrexate, at screening
- Receipt of any Disease Modifying Antirheumatic Drug (DMARD), other than methotrexate, within 3 months before screening
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: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Phase 1 Etanercept + methotrexate
Phase 1: Etanercept + methotrexate
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Phase 1: prefilled syringe 50mg/ml, administered once weekly for study weeks 0 - 24
Outros nomes:
Phase 1: oral tablet, 2.5mg, dose variable from 7.5mg to 25mg, once weekly for study weeks 0 - 24.
Phase 2: All therapies are optional and may include any combination of the following: ETN, SSZ, HCQ, MTX Phase 2: Optional ETN: prefilled syringe 50mg/ml, dose variable after study week 24 to week 128. Phase 2: Optional SSZ: oral tablet, 0.5gm, dose variable per approved local label recommendations after study week 24 to week 128. Phase 2: HCQ: oral tablet, 200mg, dose variable per approved local label recommendations after study week 24 to week 128. Phase 2: MTX: oral tablet, 2.5mg dose variable after week 24 to week 128.
Phase 1: oral tablet, 2.5mg dose variable from 7.5mg to 25mg, once weekly for study weeks 0 - 24.
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Comparador Ativo: Phase 1 Conventional DMARD (SSZ or HCQ) + MTX
Phase 1: Sulfasalazine (SSZ) + methotrexate (MTX) OR Phase 1: Hydrocholoquine (HCQ) + methotrexate
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Phase 1: oral tablet, 2.5mg, dose variable from 7.5mg to 25mg, once weekly for study weeks 0 - 24.
Phase 1: oral tablet, 2.5mg dose variable from 7.5mg to 25mg, once weekly for study weeks 0 - 24.
Phase 1: SSZ: oral tablet, 0.5gm, dose variable per approved local label recommendations.
OR Phase 1: HCQ: oral tablet, 200mg, dose variable per approved local label recommendations.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Percentage of Participants Achieving American College of Rheumatology 50 (ACR50) Response at Week 24
Prazo: Week 24
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ACR50 response: greater than or equal to 50 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 50 percent improvement from Baseline 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; participant's self-assessed disability (disability index of the Health Assessment Questionnaire; HAQ); and C-Reactive Protein (CRP).
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Week 24
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change From Baseline in HAQ Score at Week 24
Prazo: Baseline and Week 24
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HAQ: self-reported, valid assessment of functional disability in rheumatoid arthritis.
Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities.
HAQ score range: 0-3: without any difficulty: 0, with some difficulty: 1, with much difficulty: 2, unable to do: 3. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25: normal functioning; 0.25-0.5:
mild functional limitation; 0.5-1: moderate functional limitation; more than 1: significant functional limitation.
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Baseline and Week 24
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Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score at Week 24
Prazo: Baseline and Week 24
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The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health.
Domain scores range from 0-100, with greater scores reflecting better health status.
Two additional overall summary scores - physical and mental component scores - were also obtained.
Summary scores are standardized where the general population mean is 50 with a standard deviation of 10.
Greater scores again indicate better health status.
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Baseline and Week 24
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Change From Baseline in Van Der Heijde Modified Total Sharp Score (vdH mTSS), Annualized, at Week 24
Prazo: Baseline and Week 24
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mTSS: sum of erosion and joint space narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot).
mTSS scores ranged from 0 (normal) to 448 (worst possible total score).
Each x-ray visit included 4 films, each of which were read by 2 readers.
The mTSS was calculated by the images scored for erosions and JSN.
An increase in mTSS from Baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
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Baseline and Week 24
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Change From Baseline in Disease Activity Score Based on a 28-joint Count (DAS28) at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Prazo: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
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DAS28 calculated from the number of swollen joints and painful joints using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour; mm/hour) and the participant's general health using a 100 mm-visual analog scale (VAS).
DAS28<3.2 indicates low disease activity and DAS28<2.6 remission.
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Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
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Change From Baseline in DAS28 at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Prazo: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
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DAS28 calculated from the number of swollen joints and painful joints using the 28 joints count, the ESR (mm/hour) and the participant's general health using a 100 mm-VAS.
DAS28<3.2 indicates low disease activity and DAS28<2.6 remission.
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Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
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Summary of Changes in Therapy at the Beginning of Phase 2
Prazo: Week 24
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The investigators were allowed to alter each participant's therapy at the beginning of Phase 2. Continuations, discontinuations and additions made to Phase 1 treatment regimen were summarized.
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Week 24
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Percentage of Participants Achieving ACR50 Response at Week 2, Week 4, Week 8, Week 12, Week 16, and Week 20
Prazo: Week 2, Week 4, Week 8, Week 12, Week 16, and Week 20
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ACR50 response: greater than or equal to 50 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 50 percent improvement from Baseline 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; participant's self-assessed disability (disability index of HAQ); and CRP.
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Week 2, Week 4, Week 8, Week 12, Week 16, and Week 20
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Percentage of Participants Achieving ACR50 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Prazo: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
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ACR50 response: greater than or equal to 50 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 50 percent improvement from Baseline 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; participant's self-assessed disability (disability index of HAQ); and ESR.
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Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
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Percentage of Participants Achieving ACR20 Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Prazo: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
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ACR20 response: greater than or equal to 20 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 20 percent improvement from Baseline 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; participant's self-assessed disability (disability index of HAQ); and CRP.
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Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
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Percentage of Participants Achieving ACR20 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Prazo: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
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ACR20 response: greater than or equal to 20 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 20 percent improvement from Baseline 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; participant's self-assessed disability (disability index of HAQ); and ESR.
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Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
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Percentage of Participants Achieving ACR70 Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Prazo: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
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ACR70 response: greater than or equal to 50 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 70 percent improvement from Baseline 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; participant's self-assessed disability (disability index of HAQ); and CRP.
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Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
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Percentage of Participants Achieving ACR70 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Prazo: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
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ACR70 response: greater than or equal to 70 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 70 percent improvement from Baseline 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; participant's self-assessed disability (disability index of HAQ); and ESR.
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Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
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Change From Baseline in Disease Activity Score (DAS) at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Prazo: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
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DAS calculated from number of painful joints using the ritchie articular index (RAI), number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant's general health using a 100 mm-VAS.
DAS≤2.4 indicates low disease activity and DAS<1.6 remission.
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Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
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Change From Baseline in DAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Prazo: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
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DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant's general health using a 100 mm-VAS.
DAS≤2.4 indicates low disease activity and DAS<1.6 remission.
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Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
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Percentage of Participants Achieving DAS<2.4 (Low Disease Activity) Response at Week 24
Prazo: Week 24
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DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant's general health using a 100 mm-VAS.
DAS<2.4:
low disease activity, DAS<1.6:
remission.
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Week 24
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Percentage of Participants Achieving DAS<1.6 (Remission) Response at Week 24
Prazo: Week 24
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DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant's general health using a 100 mm-VAS.
DAS<2.4:
low disease activity, DAS<1.6:
remission.
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Week 24
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Percentage of Participants Achieving DAS Improvement of ≥0.6 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Prazo: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
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DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant's general health using a 100 mm-VAS.
DAS<2.4:
low disease activity, DAS<1.6:
remission.
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Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
|
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Percentage of Participants Achieving DAS Improvement of ≥0.6 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Prazo: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
|
DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant's general health using a 100 mm-VAS.
DAS<2.4:
low disease activity, DAS<1.6:
remission.
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Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
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Percentage of Participants Achieving DAS Improvement of ≥1.2 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Prazo: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
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DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant's general health using a 100 mm-VAS.
DAS<2.4:
low disease activity, DAS<1.6:
remission.
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Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
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Percentage of Participants Achieving DAS Improvement of ≥1.2 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Prazo: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
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DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant's general health using a 100 mm-VAS.
DAS<2.4:
low disease activity, DAS<1.6:
remission.
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Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
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Percentage of Participants Achieving Moderate/Good DAS-Based European League Against Rheumatism (EULAR) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Prazo: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
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DAS-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Moderate or good DAS-based EULAR response was defined as:
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Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
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Percentage of Participants Achieving Moderate/Good Disease DAS-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Prazo: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
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DAS-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Moderate or good DAS-based EULAR response was defined as:
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Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
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Percentage of Participants Achieving Good DAS-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Prazo: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
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DAS-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached.
Good DAS-based EULAR response was defined as: DAS-value ≤2.4 and DAS-improvement from Baseline >1.2.
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Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
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Percentage of Participants Achieving Good DAS-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Prazo: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
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DAS-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached.
Good DAS-based EULAR response was defined as: DAS-value ≤2.4 and DAS-improvement from Baseline >1.2.
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Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
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Percentage of Participants Achieving Moderate/Good DAS28-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Prazo: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
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DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Moderate or good DAS28-based EULAR response was defined as:
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Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
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Percentage of Participants Achieving Moderate/Good DAS28-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Prazo: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
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DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Moderate or good DAS28-based EULAR response was defined as:
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Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
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Percentage of Participants Achieving Good DAS28-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Prazo: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
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DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached.
Good DAS28-based EULAR response was defined as: DAS28-value ≤3.2 and DAS28-improvement from Baseline >1.2.
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Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
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Percentage of Participants Achieving Good DAS28-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Prazo: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
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DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached.
Good DAS28-based EULAR response was defined as: DAS28-value ≤3.2 and DAS28-improvement from Baseline >1.2.
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Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
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Percentage of Participants Achieving DAS28<2.6 (Remission) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Prazo: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
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DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant's general health using a 100 mm-VAS.
DAS28<3.2:
low disease activity, DAS28<2.6:
remission.
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Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
|
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Percentage of Participants Achieving DAS28<2.6 (Remission) Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Prazo: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
|
DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant's general health using a 100 mm-VAS.
DAS28<3.2:
low disease activity, DAS28<2.6:
remission.
|
Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
|
|
Percentage of Participants Achieving DAS28<3.2 (Low Disease Activity) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Prazo: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
|
DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant's general health using a 100 mm-VAS.
DAS28<3.2:
low disease activity, DAS28<2.6:
remission.
|
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
|
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Percentage of Participants Achieving DAS28<3.2 (Low Disease Activity) Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Prazo: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
|
DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant's general health using a 100 mm-VAS.
DAS28<3.2:
low disease activity, DAS28<2.6:
remission.
|
Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
|
|
Percentage of Participants Achieving DAS28 Improvement of ≥0.6 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Prazo: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
|
DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant's general health using a 100 mm-VAS.
DAS28<3.2:
low disease activity, DAS28<2.6:
remission.
|
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
|
|
Percentage of Participants Achieving DAS28 Improvement of ≥0.6 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Prazo: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
|
DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant's general health using a 100 mm-VAS.
DAS28<3.2:
low disease activity, DAS28<2.6:
remission.
|
Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
|
|
Percentage of Participants Achieving DAS28 Improvement of ≥1.2 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Prazo: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
|
DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant's general health using a 100 mm-VAS.
DAS28<3.2:
low disease activity, DAS28<2.6:
remission.
|
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
|
|
Percentage of Participants Achieving DAS28 Improvement of ≥1.2 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Prazo: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
|
DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant's general health using a 100 mm-VAS.
DAS28<3.2:
low disease activity, DAS28<2.6:
remission.
|
Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
|
|
Change From Baseline in Painful Joint Counts at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Prazo: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
|
Painful joint count is a physical assessment of the ACR-specified 68 joint set for tenderness/pain.
Each joint is rated as either painful or not painful with the total number of painful joints reported as the score.
Score range is from 0-68 with lower scores indicating the better outcome.
|
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
|
|
Change From Baseline in Painful Joint Counts at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Prazo: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
|
Painful joint count is a physical assessment of the ACR-specified 68 joint set for tenderness/pain.
Each joint is rated as either painful or not painful with the total number of painful joints reported as the score.
Score range is from 0-68 with lower scores indicating the better outcome.
|
Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
|
|
Change From Baseline in Swollen Joint Counts at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Prazo: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
|
Swollen joint count is a physical assessment of the ACR-specified 66 joint set for swelling.
Each joint is rated as either swollen or not swollen with the total number of swollen joints reported as the score.
Score range is from 0-66 with lower scores indicating the better outcome.
|
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
|
|
Change From Baseline in Swollen Joint Counts at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Prazo: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
|
Swollen joint count is a physical assessment of the ACR-specified 66 joint set for swelling.
Each joint is rated as either swollen or not swollen with the total number of swollen joints reported as the score.
Score range is from 0-66 with lower scores indicating the better outcome.
|
Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
|
|
Change From Baseline in Physician Global Assessment Score at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Prazo: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
|
The participant's global disease activity was estimated over the preceding 2-3 days on a scale from 0 (no disease activity) to 10 (extreme disease activity) by the physician.
|
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
|
|
Change From Baseline in Physician Global Assessment Score at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Prazo: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
|
The participant's global disease activity was estimated over the preceding 2-3 days on a scale from 0 (no disease activity) to 10 (extreme disease activity) by the physician.
|
Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
|
|
Change From Baseline in Subject Global Assessment Score at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
Prazo: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
|
The participant assessed overall arthritis activity on a scale from 0 (no disease activity) to 10 (extreme disease activity).
|
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
|
|
Change From Baseline in Subject Global Assessment Score at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Prazo: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
|
The participant assessed overall arthritis activity on a scale from 0 (no disease activity) to 10 (extreme disease activity).
|
Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
|
|
Change From Baseline in Duration of Morning Stiffness at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Prazo: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
|
The duration of morning stiffness was determined over the preceding 2 days using a 2-question worksheet.
|
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
|
|
Change From Baseline in Duration of Morning Stiffness at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Prazo: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
|
The duration of morning stiffness was determined over the preceding 2 days using a 2-question worksheet.
|
Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
|
|
Change From Baseline in General Health VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Prazo: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
|
The participants had to indicate on a 100 mm-VAS (0 mm: very well, 100 mm: extremely bad) in general how they rated their health over the preceding 2-3 weeks.
|
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
|
|
Change From Baseline in General Health VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Prazo: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
|
The participants had to indicate on a 100 mm-VAS (0 mm: very well, 100 mm: extremely bad) in general how they rated their health over the preceding 2-3 weeks.
|
Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
|
|
Change From Baseline in Pain VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Prazo: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
|
The participants had to indicate on a 100 mm-VAS (0 mm: no pain, 100 mm: pain as bad as it could be) the amount of pain they experienced over the preceding 2-3 days.
|
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
|
|
Change From Baseline in Pain VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Prazo: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
|
The participants had to indicate on a 100 mm-VAS (0 mm: no pain, 100 mm: pain as bad as it could be) the amount of pain they experienced over the preceding 2-3 days.
|
Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
|
|
Change From Baseline in Fatigue VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Prazo: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
|
The participants had to indicate on a 100 mm-VAS (0 mm: no fatigue, 100 mm: a great deal of fatigue) how much of a problem had fatigue or tiredness been for them in the preceding week.
|
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
|
|
Change From Baseline in Fatigue VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Prazo: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
|
The participants had to indicate on a 100 mm-VAS (0 mm: no fatigue, 100 mm: a great deal of fatigue) how much of a problem had fatigue or tiredness been for them in the preceding week.
|
Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
|
|
Change From Baseline in Joint Space Narrowing Score Using vdH mTSS at Week 24
Prazo: Week 24
|
mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot).
mTSS scores ranged from 0 (normal) to 448 (worst possible total score).
Each x-ray visit included 4 films, each of which were read by 2 readers.
The mTSS was calculated by the images scored for erosions and JSN.
An increase in mTSS from Baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
|
Week 24
|
|
Change From Baseline in Erosion Score Using vdH mTSS at Week 24
Prazo: Week 24
|
mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot).
mTSS scores ranged from 0 (normal) to 448 (worst possible total score).
Each x-ray visit included 4 films, each of which were read by 2 readers.
The mTSS was calculated by the images scored for erosions and JSN.
An increase in mTSS from Baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
|
Week 24
|
|
Change From Baseline in Westergren ESR at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Prazo: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
|
ESR is a laboratory test that provides a non-specific measure of inflammation.
The test assesses the rate at which red blood cells fall in a test tube.
Normal range is 0-30 mm/hour.
A higher rate is consistent with inflammation.
ESR was performed at the investigative site using an ESR kit supplied by the centralized laboratory.
|
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
|
|
Change From Baseline in Westergren ESR at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Prazo: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
|
ESR is a laboratory test that provides a non-specific measure of inflammation.
The test assesses the rate at which red blood cells fall in a test tube.
Normal range is 0-30 mm/hour.
A higher rate is consistent with inflammation.
ESR was performed at the investigative site using an ESR kit supplied by the centralized laboratory.
|
Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
|
|
Change From Baseline in CRP at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Prazo: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
|
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay.
A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
CRP was analysed at a central laboratory.
|
Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
|
|
Change From Baseline in SF-36 Health Survey Vitality Domain Score at Week 8, Week 16, and Week 24
Prazo: Week 8, Week 16, and Week 24
|
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health.
Domain scores range from 0-100, with greater scores reflecting better health status.
Two additional overall summary scores - physical and mental component scores - were also obtained.
Summary scores are standardized where the general population mean is 50 with a standard deviation of 10.
Greater scores again indicate better health status.
|
Week 8, Week 16, and Week 24
|
|
Change From Baseline in SF-36 Health Survey Vitality Domain Score at Week 50, Week 76, Week 102, and Week 128
Prazo: Week 50, Week 76, Week 102, and Week 128
|
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health.
Domain scores range from 0-100, with greater scores reflecting better health status.
Two additional overall summary scores - physical and mental component scores - were also obtained.
Summary scores are standardized where the general population mean is 50 with a standard deviation of 10.
Greater scores again indicate better health status.
|
Week 50, Week 76, Week 102, and Week 128
|
|
Change From Baseline in SF-36 Health Survey Mental Component Score at Week 8, Week 16, and Week 24
Prazo: Week 8, Week 16, and Week 24
|
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health.
Domain scores range from 0-100, with greater scores reflecting better health status.
Two additional overall summary scores - physical and mental component scores - were also obtained.
Summary scores are standardized where the general population mean is 50 with a standard deviation of 10.
Greater scores again indicate better health status.
|
Week 8, Week 16, and Week 24
|
|
Change From Baseline in SF-36 Health Survey Mental Component Score at Week 50, Week 76, Week 102, and Week 128
Prazo: Week 50, Week 76, Week 102, and Week 128
|
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health.
Domain scores range from 0-100, with greater scores reflecting better health status.
Two additional overall summary scores - physical and mental component scores - were also obtained.
Summary scores are standardized where the general population mean is 50 with a standard deviation of 10.
Greater scores again indicate better health status.
|
Week 50, Week 76, Week 102, and Week 128
|
|
Change From Baseline in SF-36 Health Survey Physical Component Score at Week 8, Week 16, and Week 24
Prazo: Week 8, Week 16, and Week 24
|
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health.
Domain scores range from 0-100, with greater scores reflecting better health status.
Two additional overall summary scores - physical and mental component scores - were also obtained.
Summary scores are standardized where the general population mean is 50 with a standard deviation of 10.
Greater scores again indicate better health status.
|
Week 8, Week 16, and Week 24
|
|
Change From Baseline in SF-36 Health Survey Physical Component Score at Week 50, Week 76, Week 102, and Week 128
Prazo: Week 50, Week 76, Week 102, and Week 128
|
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health.
Domain scores range from 0-100, with greater scores reflecting better health status.
Two additional overall summary scores - physical and mental component scores - were also obtained.
Summary scores are standardized where the general population mean is 50 with a standard deviation of 10.
Greater scores again indicate better health status.
|
Week 50, Week 76, Week 102, and Week 128
|
|
Change From Baseline in SF-36 Health Survey Bodily Pain Domain Score at Week 8, Week 16, and Week 24
Prazo: Week 8, Week 16, and Week 24
|
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health.
Domain scores range from 0-100, with greater scores reflecting better health status.
Two additional overall summary scores - physical and mental component scores - were also obtained.
Summary scores are standardized where the general population mean is 50 with a standard deviation of 10.
Greater scores again indicate better health status.
|
Week 8, Week 16, and Week 24
|
|
Change From Baseline in SF-36 Health Survey Role Limitations Due to Emotional Problems Domain Score at Week 8, Week 16, and Week 24
Prazo: Week 8, Week 16, and Week 24
|
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health.
Domain scores range from 0-100, with greater scores reflecting better health status.
Two additional overall summary scores - physical and mental component scores - were also obtained.
Summary scores are standardized where the general population mean is 50 with a standard deviation of 10.
Greater scores again indicate better health status.
|
Week 8, Week 16, and Week 24
|
|
Change From Baseline in SF-36 Health Survey General Health Perceptions Domain Score at Week 8, Week 16, and Week 24
Prazo: Week 8, Week 16, and Week 24
|
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health.
Domain scores range from 0-100, with greater scores reflecting better health status.
Two additional overall summary scores - physical and mental component scores - were also obtained.
Summary scores are standardized where the general population mean is 50 with a standard deviation of 10.
Greater scores again indicate better health status.
|
Week 8, Week 16, and Week 24
|
|
Change From Baseline in SF-36 Health Survey Mental Health Domain Score at Week 8, Week 16, and Week 24
Prazo: Week 8, Week 16, and Week 24
|
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health.
Domain scores range from 0-100, with greater scores reflecting better health status.
Two additional overall summary scores - physical and mental component scores - were also obtained.
Summary scores are standardized where the general population mean is 50 with a standard deviation of 10.
Greater scores again indicate better health status.
|
Week 8, Week 16, and Week 24
|
|
Change From Baseline in SF-36 Health Survey Physical Functioning Domain Score at Week 8, Week 16, and Week 24
Prazo: Week 8, Week 16, and Week 24
|
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health.
Domain scores range from 0-100, with greater scores reflecting better health status.
Two additional overall summary scores - physical and mental component scores - were also obtained.
Summary scores are standardized where the general population mean is 50 with a standard deviation of 10.
Greater scores again indicate better health status.
|
Week 8, Week 16, and Week 24
|
|
Change From Baseline in SF-36 Health Survey Role Limitations Due to Physical Health Domain Score at Week 8, Week 16, and Week 24
Prazo: Week 8, Week 16, and Week 24
|
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health.
Domain scores range from 0-100, with greater scores reflecting better health status.
Two additional overall summary scores - physical and mental component scores - were also obtained.
Summary scores are standardized where the general population mean is 50 with a standard deviation of 10.
Greater scores again indicate better health status.
|
Week 8, Week 16, and Week 24
|
|
Change From Baseline in SF-36 Health Survey Social Functioning Domain Score at Week 8, Week 16, and Week 24
Prazo: Week 8, Week 16, and Week 24
|
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health.
Domain scores range from 0-100, with greater scores reflecting better health status.
Two additional overall summary scores - physical and mental component scores - were also obtained.
Summary scores are standardized where the general population mean is 50 with a standard deviation of 10.
Greater scores again indicate better health status.
|
Week 8, Week 16, and Week 24
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Fleischmann R, Koenig AS, Szumski A, Nab HW, Marshall L, Bananis E. Short-term efficacy of etanercept plus methotrexate vs combinations of disease-modifying anti-rheumatic drugs with methotrexate in established rheumatoid arthritis. Rheumatology (Oxford). 2014 Nov;53(11):1984-93. doi: 10.1093/rheumatology/keu235. Epub 2014 Jun 6.
- de la Vega M, Guerra Bautista G, Xavier RM, Pacheco-Tena C, Solano G, Pedersen RD, Szumski AE, Borlenghi C, Santana K, Vlahos B. Predictors of response to etanercept-methotrexate treatment: a post hoc logistic regression analysis of a randomized, open-label study in Latin American patients with rheumatoid arthritis. Adv Rheumatol. 2021 Sep 8;61(1):56. doi: 10.1186/s42358-021-00213-4.
- Guerra Bautista G, Xavier RM, de la Vega M, Simon-Campos JA, Solano G, Pedersen RD, Vlahos B, Borlenghi C. Clinical Improvements as Predictors of Improvements in Patient-Reported Outcomes: Post Hoc Analysis of a Randomized, Open-Label Study of Etanercept in Latin American Patients with Rheumatoid Arthritis. Open Access Rheumatol. 2019 Dec 12;11:275-281. doi: 10.2147/OARRR.S228866. eCollection 2019.
- Machado DA, Guzman R, Xavier RM, Simon JA, Mele L, Shen Q, Pedersen R, Kotak S, Vlahos B. Two-Year Safety and Efficacy Experience in Patients with Methotrexate-Resistant Active Rheumatoid Arthritis Treated with Etanercept and Conventional Disease-Modifying Anti-rheumatic Drugs in the Latin American Region. Open Rheumatol J. 2016 Feb 29;10:13-25. doi: 10.2174/1874312901610010013. eCollection 2016.
- Machado DA, Guzman RM, Xavier RM, Simon JA, Mele L, Pedersen R, Ferdousi T, Koenig AS, Kotak S, Vlahos B. Open-label observation of addition of etanercept versus a conventional disease-modifying antirheumatic drug in subjects with active rheumatoid arthritis despite methotrexate therapy in the Latin American region. J Clin Rheumatol. 2014 Jan;20(1):25-33. doi: 10.1097/RHU.0000000000000055.
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 junho de 2009
Conclusão Primária (Real)
1 de abril de 2013
Conclusão do estudo (Real)
1 de abril de 2013
Datas de inscrição no estudo
Enviado pela primeira vez
18 de fevereiro de 2009
Enviado pela primeira vez que atendeu aos critérios de CQ
19 de fevereiro de 2009
Primeira postagem (Estimativa)
20 de fevereiro de 2009
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
18 de janeiro de 2016
Última atualização enviada que atendeu aos critérios de controle de qualidade
11 de dezembro de 2015
Última verificação
1 de dezembro de 2015
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças do sistema imunológico
- Doenças autoimunes
- Doenças articulares
- Doenças musculoesqueléticas
- Doenças Reumáticas
- Doenças do Tecido Conjuntivo
- Artrite
- Artrite, Reumatóide
- Efeitos Fisiológicos das Drogas
- Mecanismos Moleculares de Ação Farmacológica
- Agentes do Sistema Nervoso Periférico
- Inibidores da Síntese de Ácido Nucleico
- Inibidores Enzimáticos
- Analgésicos
- Agentes do Sistema Sensorial
- Agentes anti-inflamatórios não esteróides
- Analgésicos, Não Narcóticos
- Antiinflamatórios
- Agentes Antirreumáticos
- Antimetabólitos, Antineoplásicos
- Antimetabólitos
- Agentes Antineoplásicos
- Agentes imunossupressores
- Fatores imunológicos
- Agentes gastrointestinais
- Agentes dermatológicos
- Agentes de Controle Reprodutivo
- Agentes abortivos, não esteróides
- Agentes abortivos
- Antagonistas do ácido fólico
- Etanercepte
- Metotrexato
Outros números de identificação do estudo
- 0881A1-4532
- B1801004 (Outro identificador: Alias Study Number)
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .