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Study of Abatacept Versus Placebo to Assess the Prevention of Rheumatoid Arthritis (RA) in Adult Patients

18 de março de 2015 atualizado por: Bristol-Myers Squibb

A Phase II Study of Abatacept Versus Placebo to Assess the Prevention of Rheumatoid Arthritis (RA) in Adult Patients With Undifferentiated Arthritis Who Are at High Risk for the Development of RA

The purpose of this study is to assess if Abatacept given for six months will prevent rheumatoid arthritis (RA) in patients who are at risk for the development of RA in comparison to placebo. High risk patients are defined as those having a positive laboratory test for anti-cyclic citrullinated peptide (anti-CCP2).

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

56

Estágio

  • Fase 2

Contactos e Locais

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

Locais de estudo

  • Alemanha
      • Berlin, Alemanha
        • Local Institution
      • Dresden, Alemanha
        • Local Institution
      • Hamburg, Alemanha
        • Local Institution
      • Hannover, Alemanha
        • Local Institution
      • Heidelberg, Alemanha
        • Local Institution
  • Austrália
    • Queensland
      • Cairns, Queensland, Austrália
        • Local Institution
    • Victoria
      • Clayton, Victoria, Austrália
        • Local Institution
      • Malvern, Victoria, Austrália
        • Local Institution
    • Western Australia
      • Shenton Park, Western Australia, Austrália
        • Local Institution
  • Bélgica
      • Bruxelles, Bélgica
        • Local Institution
      • Leuven, Bélgica
        • Local Institution
  • Espanha
      • A Coruna, Espanha
        • Local Institution
      • Barcelona, Espanha
        • Local Institution
      • Madrid, Espanha
        • Local Institution
      • Oviedo, Espanha
        • Local Institution
      • Sevilla, Espanha
        • Local Institution
  • Estados Unidos
    • Alabama
      • Huntsville, Alabama, Estados Unidos
        • Local Institution
      • Mobile, Alabama, Estados Unidos
        • Local Institution
    • California
      • Huntington Beach, California, Estados Unidos
        • Local Institution
      • Los Angeles, California, Estados Unidos
        • Local Institution
    • Colorado
      • Boulder, Colorado, Estados Unidos
        • Local Institution
      • Colorado Springs, Colorado, Estados Unidos
        • Local Institution
    • Florida
      • Ft. Lauderdale, Florida, Estados Unidos
        • Local Institution
    • Illinois
      • Chicago, Illinois, Estados Unidos
        • Local Institution
    • Indiana
      • Evansville, Indiana, Estados Unidos
        • Local Institution
    • Louisiana
      • New Orleans, Louisiana, Estados Unidos
        • Local Institution
    • Maryland
      • Cumberland, Maryland, Estados Unidos
        • Local Institution
      • Hagerstown, Maryland, Estados Unidos
        • Local Institution
    • Minnesota
      • Duluth, Minnesota, Estados Unidos
        • Local Institution
    • North Carolina
      • Durham, North Carolina, Estados Unidos
        • Local Institution
      • Wilmington, North Carolina, Estados Unidos
        • Local Institution
    • Oklahoma
      • Oklahoma City, Oklahoma, Estados Unidos
        • Local Institution
    • Pennsylvania
      • Willow Grove, Pennsylvania, Estados Unidos
        • Local Institution
    • South Carolina
      • Charleston, South Carolina, Estados Unidos
        • Local Institution
    • Texas
      • Austin, Texas, Estados Unidos
        • Local Institution
    • Virginia
      • Arlington, Virginia, Estados Unidos
        • Local Institution
  • França
      • Paris, França
        • Local Institution
      • Strasbourg Cedex, França
        • Local Institution
  • Itália
      • Bari, Itália
        • Local Institution
      • Ferrara, Itália
        • Local Institution
      • Milano, Itália
        • Local Institution
  • México
    • Distrito Federal
      • Guadalajara, Distrito Federal, México
        • Local Institution
    • Guanajuato
      • Leon, Guanajuato, México
        • Local Institution
    • Jalisco
      • Guadalajara, Jalisco, México
        • Local Institution
    • Michioacan
      • Morelia, Michioacan, México
        • Local Institution
  • Porto Rico
      • Ponce, Porto Rico
        • Local Institution
  • Reino Unido
    • Merseyside
      • Liverpool, Merseyside, Reino Unido
        • Local Institution
    • North Yorkshire
      • Leeds, North Yorkshire, Reino Unido
        • Local Institution

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 75 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Diagnosis of undifferentiated arthritis
  • Clinical synovitis of two or more joints
  • At least one but not more than three of the criteria for diagnosis of RA (1987).
  • No prior disease modifying anti-rheumatic drugs (DMARDs)/biologics.
  • Duration of disease must be 18 months or less.
  • Positive for antibodies against cyclic citrullinated peptides.

Exclusion Criteria:

  • Women of child bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy.
  • Active vasculitis of a major organ system.
  • Severe or recurrent bacterial infection.
  • History of cancer in the last five years except certain skin cancers.
  • Herpes zoster that resolved less than 2 months prior to enrollment

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

  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador de Placebo: 2
Medicamento: placebo
solution, intravenous injection, 0 mg, monthly, 169 days
Comparador Ativo: 1
Medicamento: Abatacept

solution, intravenous injection, monthly, 169 days

weight based:

<60 kg = 500 mg

60 to 100 kg = 750 mg

>100 kg = 1 g

Outros nomes:
  • Orencia

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Number of Participants With a Diagnosis of Rheumatoid Arthritis (RA) by American Rheumatism Association (ARA) Criteria and/or Discontinued Due to Lack of Efficacy
Prazo: 12 months
ARA criteria is a 7-item tool for RA classification purposes; a patient is said to have RA (meeting endpoint) if he or she has satisfied at least 4 of the 7 criteria. If a participant discontinued due to lack of efficacy, he/she was regarded as meeting primary endpoint also.
12 months

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Number of Participants With a Diagnosis of RA by 1987 ARA Criteria and/or Discontinued Due to Lack of Efficacy
Prazo: 24 months
ARA criteria is a 7-item tool for classification purposes; a patient is said to have RA (meeting endpoint) if he or she has satisfied at least 4 of the 7 criteria. If a participant discontinued due to lack of efficacy, he/she was regarded as meeting endpoint also.
24 months
Number of Participants With Undifferentiated Inflammatory Arthritis (UA) Who Develop Another Rheumatic Disease
Prazo: 12 months, 24 months
Clinical diagnosis of other rheumatic diseases at 12 and 24 months. If a participant discontinued due to lack of efficacy, he/she was regarded as meeting endpoint also.
12 months, 24 months
Change From Baseline in Radiographic Erosion and Joint Space Narrowing Score at 6 Months, 12 Months, and 24 Months
Prazo: Baseline, 6 months, 12 months, 24 months
Mean change from baseline using the Genant-Modified Sharp Score. Erosion score=assessment of 14 sites in each hand and wrist + 6 joints in each foot, using an 8-point scale from 0 (no erosions) to 3.5 (erosions of 100% or articular surfaces). Joint score= assessment of 13 sites in each wrist and hand + 6 sites in each foot using a 9-point scale from 0 (normal) to 4.0 (definite ankylosis). As-observed data. Change from Baseline=postbaseline score at timepoint (6 or 12 or 24 months) minus baseline score; a lower value signifies improvement.
Baseline, 6 months, 12 months, 24 months
Change From Baseline in Total Erosion, Edema, Synovitis Scores at 6 Months, 12 Months, and 24 Months
Prazo: Baseline, 6 months, 12 months, 24 months
Mean change from baseline. Degree of synovitis and structural joint damage (erosion, edema) of the carpal and metacarpophalangeal joints, as measured by magnetic resonance imaging (MRI) scores using the European League Against Rheumatism (EULAR)-Outcome Measures in Rheumatology Clinical Trials (OMERACT) assessment. Edema scale=0 (no bone involved) to 3 (67% to 100% of bone involved). Synovitis scale=0 (normal) and 1-3 (mild, moderate, severe. Bone erosion scale=0 (0% of bone involved) to 10 (91% to 100% of bone involved). Change from baseline=postbaseline score at timepoint - baseline score.
Baseline, 6 months, 12 months, 24 months
Number of Participants With Persistent Symptomatic Clinical Synovitis
Prazo: 6, 12, and 24 months
Synovitis, assessed by clinical signs and symptoms
6, 12, and 24 months
Short Form-36 (SF-36) Physical and Mental Component Summary (PCS and MCS) Scores - Mean Change From Baseline
Prazo: 6 months, 12 months, 24 months
SF-36, a 36-item instrument that covers 8 quality of life domains, which were used to derive the physical and mental component summary scores, which ranged from 0 to 100, with higher scores indicating a better quality of life. Change from baseline=postbaseline - baseline value; a higher value signifies improvement.
6 months, 12 months, 24 months
Change From Baseline in Cytokine Levels and Second Generation Anti-cyclic Citrullinated Peptide (Anti-CCP2) Antibodies at 6 Months, 12 Months, and 24 Months
Prazo: Baseline, 6 Months, 12 months, 24 months
To assess pharmacodynamic effect of abatacept on serum levels of autoantibodies, mean change from baseline in cytokines (interleukin-6 [IL-6], interleukin-1B [IL-1B], tumor necrosis factor Alpha [TNF-Alpha], Matrix Metalloproteinase 3T [MMP3T], and anti-CCP2), as measured by standard laboratory investigations, were assessed. Change from baseline=postbaseline value at timepoint (6 or 12 or 24 months) minus baseline value; a lower value signifies improvement.
Baseline, 6 Months, 12 months, 24 months
Number of Participants With Anti-CCP2 Positive and/or Rheumatoid Factor (RF) Positive Over Time
Prazo: Day 1, 6 months, 12 months, 24 months
To assess the pharmacodynamic effect of abatacept on serum levels of autoantibodies, number of participants with Anti-CCP2 Positive of Rheumatoid Factor (RF) positive
Day 1, 6 months, 12 months, 24 months
Frequency of Human Leukocyte Antigen (HLA) Typing
Prazo: Day 1
To assess the pharmacodynamic effect of abatacept on serum levels of autoantibodies, a blood sample was obtained for HLA typing to determine the presence or absence of alleles associated with RA susceptibility and severity (shared epitope alleles HLA-DRB10401 and HLA-DRB10404).
Day 1
DAS 28 C Reactive Protein (CRP) Score - Mean Change From Baseline
Prazo: 6 months, 12 months, 24 months
The DAS 28 (CRP) is a composite of 4 variables: 28 tender joint count, 28 swollen joint count, CRP, and subject assessment of disease activity measure on a VAS of 100 mm. Change from Baseline=postbaseline score-baseline score; a lower value signifies improvement.
6 months, 12 months, 24 months
Number of Participants With a DAS 28 (CRP) Score of ≤3.2 (Low Disease Activity) or <2.6 (in Remission)
Prazo: 6 months, 12 months, 24 months
The DAS 28 (CRP) is a composite of 4 variables: tender joint count, swollen joint count, CRP, and subject assessment of disease activity measure on a VAS of 100 mm. Scores for disease activity are defined as low (≤ 3.2) and in remission (< 2.6).
6 months, 12 months, 24 months
Number of Subjects With Health Assessment Questionnaire (HAQ) Disability Index Response
Prazo: 6 months, 12 months, 24 months
This questionnaire includes 20 questions assessing physical function in 8 domains. The questions are evaluated on a 4-point scale: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty and 3=unable to do. Higher scores indicate greater dysfunction. HAQ response =improvement of at least 0.3 units from baseline.
6 months, 12 months, 24 months
Overall Safety - Adverse Events (AEs), Serious AEs, and Deaths
Prazo: Throughout the treatment period (6 months)
AEs were monitored at all scheduled visits of the study drug treatment and observation periods and at the follow-up visits performed 28, 56, and 85 days after the last infusion of study medication for participants who were withdrawn prematurely
Throughout the treatment period (6 months)
Number of Participants With Positive Responses for Serum Levels of Abatacept-specific Antibodies
Prazo: Up to 12 months
Immunogenicity, as measured by the number of positive repsonses for serum levels of abatacept-specific antibodies measured by enzyme-linked immunosorbent assays (ELISA). Postive response for whole molecule assessment was a value of > 400 and for tip assessment was ≥25.
Up to 12 months

Colaboradores e Investigadores

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

Patrocinador

Bristol-Myers Squibb

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

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 fevereiro de 2005

Conclusão Primária (Real)

1 de maio de 2007

Conclusão do estudo (Real)

1 de abril de 2008

Datas de inscrição no estudo

Enviado pela primeira vez

30 de junho de 2005

Enviado pela primeira vez que atendeu aos critérios de CQ

27 de julho de 2005

Primeira postagem (Estimativa)

28 de julho de 2005

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

7 de abril de 2015

Última atualização enviada que atendeu aos critérios de controle de qualidade

18 de março de 2015

Última verificação

1 de março de 2015

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • IM101-046

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 .

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