Open-Label Extension Treatment With Etanercept (TNFR:Fc) for Participating Patients in Etanercept (TNFR:Fc) Clinical Trial 016.0012
10 de maio de 2013 atualizado por: Amgen
This is an open label, multicenter study for extended treatment of patients who have participated in the Immunex clinical study 016.0012.
The primary objective of this study is to evaluate the long term safety of etanercept (TNFR:Fc) in patients with early stage rheumatoid arthritis.
Visão geral do estudo
Tipo de estudo
Intervencional
Inscrição (Real)
468
Estágio
- Fase 3
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria: - Previous enrollment in Immunex protocol 016.0012.
- No clinically significant adverse events thought to be due to etanercept (TNFR:Fc) during previous treatment.
- Negative serum pregnancy test not more than 14 days before the first dose of study drug in females of childbearing potential.
- No more than one NSAID at a dose not greater than the maximum recommended dose and stable for at least two weeks prior to administration of etanercept (TNFR:Fc). Exclusion Criteria:
- Previous receipt of etanercept (TNFR:Fc) (p55), antibody to TNF, anti-CD4 antibody, or diphtheria IL-2 fusion protein.
- Receipt of investigational drugs or biologics (other than etanercept (TNFR:Fc)) within interval between study drug in 016.0012 and this study.
- Receipt of DMARDs (e.g., hydroxychloroquine, oral or injectable gold, azathioprine, cyclosporin, D-penicillamine, sulfasalazine, minocycline, or leflunomide) other than MTX within two weeks prior to the first dose of etanercept (TNFR:Fc) in this study.
- Receipt of cyclophosphamide within 1 month prior to the first dose of etanercept (TNFR:Fc) in this study.
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: Não randomizado
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Outro: 1
|
Etanercept (TNFR:Fc) will be administered 50 mg per week as two 25 mg subcutaneous injections at separate sites, given either on the same day or 3 or 4 days apart.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Total Exposure to Etanercept With Gaps
Prazo: Up to 8 years
|
Total participant exposure to etanercept (Enbrel) with gaps, calculated as the sum of the times on treatment for all participants.
Gaps of up to 14 days from the last treatment in a previous Etanercept study were ignored in calculating time on treatment.
|
Up to 8 years
|
|
Total Exposure-Adjusted Rate of Malignancies
Prazo: Up to 8 years
|
Exposure-adjusted rate of malignancies, excluding nonmelanoma skin cancers, occurring on study within 30 days of the last dose of etanercept
|
Up to 8 years
|
|
Total Exposure-Adjusted Rate of Deaths
Prazo: Up to 8 years
|
Rate of deaths within 30 days of the last dose of etanercept, adjusted for total exposure to etanercept
|
Up to 8 years
|
|
Total Exposure Adjusted Rate of Serious Infectious Events
Prazo: Up to 8 years
|
Exposure-adjusted rate of serious infectious events (associated with hospitalization or IV antibiotics) occurring on study within 30 days of the last dose of etanercept
|
Up to 8 years
|
|
Total Exposure Adjusted Rate of Lymphomas
Prazo: Up to 8 years
|
Rate of lymphomas occurring on study within 30 days of the last dose of etanercept, adjusted for total exposure to etanercept
|
Up to 8 years
|
|
Malignancy
Prazo: Up to 8 years
|
Occurrence of one or more malignancies within the participant on study within 30 days of the last dose of etanercept
|
Up to 8 years
|
|
Lymphoma
Prazo: Up to 8 years
|
Occurrence of one or more lymphomas on study within 30 days of the last dose of etanercept
|
Up to 8 years
|
|
Serious Infectious Event
Prazo: Up to 8 years
|
Occurrence of one or more serious infectious events within the participant on study within 30 days of the last dose of study medication
|
Up to 8 years
|
|
Total Exposure Adjusted Rate of Serious Adverse Events
Prazo: Up to 8 years
|
Rate of serious adverse events adjusted to total exposure to etanercept (events / exposure * 100)
|
Up to 8 years
|
|
Death
Prazo: Up to 8 years
|
Death of the participant on study up to 30 days after the last dose of etanercept
|
Up to 8 years
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
ACR20 Response at Month 3
Prazo: Baseline and month 3
|
American College of Rheumatology (ACR) 20, defined as a 20% improvement in both tender and swollen joints (78 joints) and a 20% improvement in 3 of 5 items (physician and patient global assessments, patient pain assessment, patient self-assessed disability, and acute-phase C-reactive protein or erythrocyte sedimentation rate)
|
Baseline and month 3
|
|
Dosing Period
Prazo: Up to 8 years
|
Duration of etanercept dosing
|
Up to 8 years
|
|
ACR20 Response at Month 12
Prazo: Baseline and month 12
|
American College of Rheumatology (ACR) 20, defined as a 20% improvement in both tender and swollen joints (78 joints) and a 20% improvement in 3 of 5 items (including physician and patient global assessments), in adults
|
Baseline and month 12
|
|
ACR50 Response at Month 12
Prazo: Baseline and month 12
|
American College of Rheumatology (ACR) 50, defined as a 50% improvement in both tender and swollen joints (78 joints) and a 50% improvement in 3 of 5 items (including physician and patient global assessments), in adults
|
Baseline and month 12
|
|
ACR70 Response at Month 12
Prazo: Baseline and month 12
|
American College of Rheumatology (ACR) 70, defined as a 70% improvement in both tender and swollen joints (78 joints) and a 70% improvement in 3 of 5 items (including physician and patient global assessments), in adults
|
Baseline and month 12
|
|
Standardized Incidence Rate for All SEER Cancers
Prazo: Up to 8 years
|
Standardized incidence rate for all cancers tracked by the National Cancer Institute's Surveillance Epidemiology and End Results (SEER) system, calculated as the ratio of the observed to expected age- and sex-adjusted incidence rates (per person-year) of cancer.
Expected rates were based on 1998-2002 SEER data.
|
Up to 8 years
|
|
Percent Improvement in Physician Global Assessment of Disease Status From Baseline to Month 12
Prazo: Baseline and month 12
|
Percent improvement in the Physician Global Assessment of disease status from baseline to month 12, assessed using a 0 - 10 Likert scale, where 0 = asymptomatic and 10 = severe symptoms
|
Baseline and month 12
|
|
Percent Improvement in Participant Global Assessment of Disease Status From Baseline to Month 12
Prazo: Baseline and Month 12
|
Percent improvement in the Participant Global Assessment of disease status from baseline to month 12, assessed using a 0 - 10 Likert scale, where 0 = asymptomatic and 10 = severe symptoms
|
Baseline and Month 12
|
|
Percent Improvement in Participant Pain Visual Analog Scale From Baseline to Month 12
Prazo: Baseline and month 12
|
Percent improvement in the Participant Pain Visual Analog Scale (VAS) from baseline to month 12, using a 10 cm scale ranging from "no pain" (0 cm) to "severe pain" (10 cm).
|
Baseline and month 12
|
|
Percent Improvement in Tender Joint Count From Baseline to Month 12
Prazo: Baseline and month 12
|
Percent improvement in tender joint count (based on up to 71 joints) from baseline to month 12. Tender joints were assessed clinically, and the number of such joints was counted at each time point.
|
Baseline and month 12
|
|
Percent Improvement in Swollen Joint Count From Baseline to Month 12
Prazo: Baseline and month 12
|
Percent improvement in swollen joint count (based on up to 68 joints) from baseline to month 12.
|
Baseline and month 12
|
|
Percent Improvement in HAQ DI From Baseline to Month 12
Prazo: Baseline and month 12
|
Percent improvement in the Health Assessment Questionnaire Disability Index (HAQ DI) from baseline to month 12.
|
Baseline and month 12
|
|
Percent Improvement in the Physical Component Summary Score for SF-36 From Baseline to Month 12
Prazo: Baseline and month 12
|
Percent improvement in the Physical Component Summary Score for the Short Form 36 Health Survey (SF-36) from baseline to month 12.
This score has a range of 0 to 100, with higher scores indicating better health.
|
Baseline and month 12
|
|
Percent Improvement in Mental Component Summary Score of SF-36 From Baseline to Month 12
Prazo: Baseline and month 12
|
Percent improvement in the Mental Component Summary Score of the Short Form 36 Health Survey (SF-36) from baseline to month 12.
This score has a range of 0 to 100, with higher scores indicating better health.
|
Baseline and month 12
|
|
Percent Improvement in C-Reactive Protein From Baseline to Month 12
Prazo: Baseline and month 12
|
Percent improvement in C-reactive protein from baseline to month 12
|
Baseline and month 12
|
|
Percent Improvement in Duration of Morning Stiffness From Baseline to Month 12
Prazo: Baseline and month 12
|
Percent improvement in the duration of morning stiffness from baseline to month 12
|
Baseline and month 12
|
|
Change From Baseline to Year 2 in Total Sharp Score
Prazo: Baseline, Year 2
|
Change from baseline to year 2 in Total Sharp Score.
This score has a range of 0 to 398, where 0 = no change and higher scores represent a worsening of joint erosions and joint space narrowing.
|
Baseline, Year 2
|
|
Change From Baseline to Year 2 in Sharp Score Erosion Subscale
Prazo: Baseline, Year 2
|
Change from baseline to year 2 in the joint erosion subscale of the Total Sharp Score.
This subscale has a range of 0 to 230, where 0 = no change and higher values represent a worsening in joint erosions.
|
Baseline, Year 2
|
|
Change From Baseline to Year 2 in Sharp Score Joint Space Narrowing Subscale
Prazo: Baseline, Year 2
|
Change from baseline to year 2 in the joint space narrowing subscale of the Total Sharp Score.
This subscale has a range of 0 to 168, where 0 = no change and higher values represent a worsening of joint space narrowing.
|
Baseline, Year 2
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
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
- Weinblatt ME, Bathon JM, Kremer JM, Fleischmann RM, Schiff MH, Martin RW, Baumgartner SW, Park GS, Mancini EL, Genovese MC. Safety and efficacy of etanercept beyond 10 years of therapy in North American patients with early and longstanding rheumatoid arthritis. Arthritis Care Res (Hoboken). 2011 Mar;63(3):373-82. doi: 10.1002/acr.20372. Epub 2010 Oct 18.
- Genovese MC, Bathon JM, Fleischmann RM, Moreland LW, Martin RW, Whitmore JB, Tsuji WH, Leff JA. Longterm safety, efficacy, and radiographic outcome with etanercept treatment in patients with early rheumatoid arthritis. J Rheumatol. 2005 Jul;32(7):1232-42.
- Genovese MC, Bathon JM, Martin RW, Fleischmann RM, Tesser JR, Schiff MH, Keystone EC, Wasko MC, Moreland LW, Weaver AL, Markenson J, Cannon GW, Spencer-Green G, Finck BK. Etanercept versus methotrexate in patients with early rheumatoid arthritis: two-year radiographic and clinical outcomes. Arthritis Rheum. 2002 Jun;46(6):1443-50. doi: 10.1002/art.10308.
Links úteis
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 dezembro de 1998
Conclusão Primária (Real)
1 de dezembro de 2008
Conclusão do estudo (Real)
1 de abril de 2009
Datas de inscrição no estudo
Enviado pela primeira vez
24 de julho de 2006
Enviado pela primeira vez que atendeu aos critérios de CQ
24 de julho de 2006
Primeira postagem (Estimativa)
26 de julho de 2006
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
14 de maio de 2013
Última atualização enviada que atendeu aos critérios de controle de qualidade
10 de maio de 2013
Última verificação
1 de maio de 2013
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
- Agentes do Sistema Nervoso Periférico
- Analgésicos
- Agentes do Sistema Sensorial
- Agentes anti-inflamatórios não esteróides
- Analgésicos, Não Narcóticos
- Antiinflamatórios
- Agentes Antirreumáticos
- Agentes imunossupressores
- Fatores imunológicos
- Agentes gastrointestinais
- Etanercepte
Outros números de identificação do estudo
- 20021623
- 16.0023
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 .