Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

Abatacept Versus Adalimumab Head-to-Head

3 de janeiro de 2014 atualizado por: Bristol-Myers Squibb

A Randomized, Head-to-Head, Single-Blind Study to Compare the Efficacy and Safety of Subcutaneous Abatacept Versus Subcutaneous Adalimumab, Both With Background Methotrexate, in Biologic-Naive Subjects With Rheumatoid Arthritis

The purpose of this study is demonstrate that subcutaneous abatacept is non-inferior (no worse than) to subcutaneous adalimumab in the treatment of subjects with rheumatoid arthritis who are biologic naive

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

869

Estágio

  • Fase 3

Contactos e Locais

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

Locais de estudo

  • Argentina
      • Cordoba, Argentina, 5000
        • Local Institution
      • San Juan, Argentina, 5400
        • Local Institution
      • Tucuman, Argentina, 4000
        • Local Institution
    • Buenos Aires
      • Ciudad Autonoma, Buenos Aires, Argentina, CP1425A WC
        • Local Institution
      • Ciudad Autonoma De Beunos Aire, Buenos Aires, Argentina, 1431
        • Local Institution
      • Ciudad Autonoma De Buenos Aire, Buenos Aires, Argentina, 1015
        • Local Institution
      • Ciudad Autonoma De Buenos Aire, Buenos Aires, Argentina, C1428DQG
        • Local Institution
      • Quilmes, Buenos Aires, Argentina, 1878
        • Local Institution
    • Cordoba
      • Cordoba, Crd, Cordoba, Argentina, X5016KEH
        • Local Institution
    • Santa Fe
      • Rosario, Santa Fe, Argentina, 2000
        • Local Institution
    • Tucuman
      • San Miguel De Tucuman, Tucuman, Argentina, 4000
        • Local Institution
  • Canadá
      • Quebec, Canadá, G1V 3M7
        • Local Institution
    • Manitoba
      • Winnipeg, Manitoba, Canadá, R3A 1M3
        • Local Institution
    • Ontario
      • Hamilton, Ontario, Canadá, L8N 1Y2
        • Local Institution
    • Quebec
      • Trois-Rivieres, Quebec, Canadá, G8Z 1Y2
        • Local Institution
  • Chile
    • Providencia
      • Santiago, Providencia, Chile
        • Local Institution
  • Estados Unidos
    • Alabama
      • Birmingham, Alabama, Estados Unidos, 35294
        • University of Alabama at Birmingham
      • Birmingham, Alabama, Estados Unidos, 35205
        • Rheumatology Associates, Pc
      • Tuscaloosa, Alabama, Estados Unidos, 35406
        • Clinical and Translational Research Center of Alabama, PC
    • Arizona
      • Peoria, Arizona, Estados Unidos, 85381
        • Sun Valley Arthritis Center, Ltd.
    • Arkansas
      • Hot Springs, Arkansas, Estados Unidos, 71913
        • Mercy Clinic Hot Springs Communities
    • California
      • Huntington Beach, California, Estados Unidos, 92646
        • Talbert Medical Group
      • La Jolla, California, Estados Unidos, 92037
        • Allergy & Rheumatology Medical Clinic, Inc.
      • Long Beach, California, Estados Unidos, 90806
        • Valerius Med Group & Res Ctr Of Greater Long Beach, Inc.
      • Pasadena, California, Estados Unidos, 91107
        • Irene Y. Tong
      • San Diego, California, Estados Unidos, 92108
        • San Diego Arthritis Medical Clinic
      • Torrance, California, Estados Unidos, 90503
        • HealthCare Partners Medical Group
      • Torrance, California, Estados Unidos, 90505
        • Drs. Goldin, Nies, Klashman & Eng
      • Upland, California, Estados Unidos, 91786
        • Inland Rheumatology & Osteoporosis Medical Group
    • Florida
      • Aventura, Florida, Estados Unidos, 33180
        • Arthritis and Rheumatic Disease Specialties
      • Gainesville, Florida, Estados Unidos, 32610
        • University Of Florida College Of Medicine At Jacksonville
      • Miami, Florida, Estados Unidos, 33173
        • Center for Arthritis and Rheumatic Diseases
      • Palm Harbor, Florida, Estados Unidos, 34684
        • Arthritis Research Of Florida, Inc.
      • Sarasota, Florida, Estados Unidos, 34239
        • Sarasota Arthritis Research Center
      • South Miami, Florida, Estados Unidos, 33143
        • Miami Research Associates
      • Tamarac, Florida, Estados Unidos, 33321
        • West Broward Rheumatology Associates
      • Venice, Florida, Estados Unidos, 34292
        • Lovelace Scientific Resources, Inc
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30342
        • Arthritis & Rheumatology of Georgia
      • Atlanta, Georgia, Estados Unidos, 30342
        • Laureate Clinical Research Group
      • Gainesville, Georgia, Estados Unidos, 30501
        • Arthritis Center of North Georgia
    • Idaho
      • Boise, Idaho, Estados Unidos, 83702
        • St. Luke's Clinic - Rheumatology
      • Coeur D Alene, Idaho, Estados Unidos, 83814
        • Coeur D'Alene Arthrit Clin
    • Illinois
      • Quincy, Illinois, Estados Unidos, 62301
        • Quincy Medical Group
      • Rockford, Illinois, Estados Unidos, 61107
        • Rockford Orthopedic Associates, Ltd.
    • Iowa
      • Cedar Rapids, Iowa, Estados Unidos, 52401
        • Physicians Clinic of Iowa
    • Kentucky
      • Elizabethtown, Kentucky, Estados Unidos, 42701
        • Center for Arthritis and Osteoporosis
      • Lexington, Kentucky, Estados Unidos, 40504
        • Bluegrass Community Research, Inc.
    • Maryland
      • Cumberland, Maryland, Estados Unidos, 21502
        • Klein And Associates, M.D., Pa
      • Wheaton, Maryland, Estados Unidos, 20902
        • The Center for Rheumatology and Bone Research
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02115
        • Brigham and Women's Hospital
      • Mansfield, Massachusetts, Estados Unidos, 02048
        • Mansfield Health Center
    • Michigan
      • Battle Creek, Michigan, Estados Unidos, 49015
        • Associated Internal Medicine Specialists
      • Kalamazoo, Michigan, Estados Unidos, 49009
        • Rheumatology Pc
    • Mississippi
      • Jackson, Mississippi, Estados Unidos, 39202
        • Arthritis Associates Of Mississippi
    • Missouri
      • St.Louis, Missouri, Estados Unidos, 63131
        • Physician Groups, Lc Dba
    • Nevada
      • Reno, Nevada, Estados Unidos, 89502
        • Arthritis Center of Reno
    • New Hampshire
      • Dover, New Hampshire, Estados Unidos, 03820
        • Seacoast Arthritis And Osteoporosis Center
      • Nashua, New Hampshire, Estados Unidos, 03060
        • Nashua Rheumatology
    • New Mexico
      • Las Cruces, New Mexico, Estados Unidos, 88011
        • Arthritis and Osteoporosis Associates of New Mexico
    • New York
      • Lake Success, New York, Estados Unidos, 11042
        • North Shore Lij Health System
      • Mineola, New York, Estados Unidos, 11501
        • Winthrop University Hospital
      • Smithtown, New York, Estados Unidos, 11787
        • Rheumatology Associates of Long Island
    • North Carolina
      • Asheville, North Carolina, Estados Unidos, 28803
        • Asheville Rheumatology & Osteoporosis Research Asso P. A.
      • Statesville, North Carolina, Estados Unidos, 28625
        • Carolina Pharmaceutical Research
    • Oklahoma
      • Oklahoma City, Oklahoma, Estados Unidos, 73109
        • Health Research Institute
      • Oklahoma City, Oklahoma, Estados Unidos, 73103
        • Health Research of Oklahoma
      • Oklahoma City, Oklahoma, Estados Unidos, 73112
        • Lynn Health Sciences Institute
    • Pennsylvania
      • Bethlehem, Pennsylvania, Estados Unidos, 18015
        • East Penn Rheumatology Associates, P.C.
      • Duncansville, Pennsylvania, Estados Unidos, 16635
        • Altoona Center for Clinical Research
      • Wyomissing, Pennsylvania, Estados Unidos, 19610
        • Clinical Research Center of Reading, LLP
    • South Carolina
      • Charleston, South Carolina, Estados Unidos, 29406
        • Low Country Rheumatology, PA
      • Columbia, South Carolina, Estados Unidos, 29204
        • Columbia Arthritis Center, P.A.
    • Texas
      • Austin, Texas, Estados Unidos, 78758
        • Lovelace Scientific Resources, Inc.
      • Dallas, Texas, Estados Unidos, 75246
        • Arthritis Centers of Texas
      • Houston, Texas, Estados Unidos, 77004
        • Rheumatic Disease Clinical Research Center, LLC
    • Virginia
      • Chesapeake, Virginia, Estados Unidos, 23320
        • Center For Arthritis & Rheumatic Diseases, Pc
    • Washington
      • Spokane, Washington, Estados Unidos, 99202
        • Rockwood Research Center
    • West Virginia
      • Clarksburg, West Virginia, Estados Unidos, 26301
        • Mountain State Clinical Research
    • Wisconsin
      • Glendale, Wisconsin, Estados Unidos, 53217
        • Rheumatic Disease Center
  • Peru
      • Lima, Peru
        • Local Institution
      • Lima, Peru, LIMA 11
        • Local Institution
      • Lima, Peru, LIMA 33
        • Local Institution
      • Lima, Peru, LIMA 27
        • Local Institution
    • Callao 2
      • Bellavista, Callao 2, Peru
        • 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 e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Moderate to severe Rheumatoid arthritis (RA) according to American College of Rheumatology (ACR) criteria
  • Methotrexate failure
  • Naive to RA biologics
  • ≤5 years duration of disease
  • Disease Activity Score-28 C-reactive protein (DAS28 CRP) ≥ 3.2
  • Willingness to self-inject subcutaneous (SC) drug

Exclusion Criteria:

  • Previous or current medical conditions that are warnings against the use of tumor necrosis factor (TNF)-blocking agents
  • History of active or chronic hepatitis
  • Cancer in the last 5 years
  • History of severe chronic or recurrent bacterial or viral infections
  • Risk of tuberculosis
  • Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic, Gastro-intestinal, pulmonary, cardiac, neurologic, or cerebral disease

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: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: Adalimumabe
Medicamento: Adalimumab
Syringes, Subcutaneous, 40 mg, Biweekly Subcutaneous injections, 24 months (729 days)
Outros nomes:
  • Humira
Comparador Ativo: Abatacept
Medicamento: Abatacept
Syringes, Subcutaneous, 125 mg/syringe for Subcutaneous, Weekly Subcutaneous injections, 24 months (729 days)
Outros nomes:
  • Orencia
  • BMS-188667

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
The Proportion of Participants Meeting the American College of Rheumatology (ACR) Criteria of 20% Improvement (ACR20) After 12 Months of Treatment - Intent to Treat Population
Prazo: Day 1 to Day 365
Proportion(%)=number of participants meeting criteria (n) divided by number of participants who received drug (N). The ACR score indicates degree of improvement in a patient's rheumatoid arthritis (RA), based on guidelines set forth by the ACR and represents a percentage. To qualify a ACR20 score, patient must have >=20% fewer tender joints and >=20% fewer swollen joints and show 20% improvement from baseline in at least 3 of: patient overall assessment of his/her RA, physician global assessment of the patient's RA, patient self-assessment of pain, patient self-assessment of physical functioning, and results of an erythrocyte sedimentation rate or C-reactive protein (CRP) test (to assess inflammation). Baseline was Day 1. Randomization was stratified using screening Disease Activity Score-28 (DAS28) CRP, a composite of 4 variables: number of tender joints/28, number of swollen joints/28, CRP in mg/L and participant assessment of disease activity with visual analogue scale.
Day 1 to Day 365

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Proportion of Participants With Local Injection Site Reactions Adverse Events (Pre-specified) Reported During 12 Month Period - ITT Population
Prazo: Day 1 to 12 Months
n=number of participants with a pre-specified local injection site reaction event, N=number of participants at risk. Proportion (%) = n/N. 12 Months includes data up to 56 days post last dose of the first 12 months Period or start of the first dose of second 12 months period.
Day 1 to 12 Months
Incidence Rate of Local Injection Site Reactions (Pre-specified) Reported During 24 Month Period - ITT Population
Prazo: Day 1 to Day 729
Incidence Rate: (incidence/100 person-years) = number of participants with event * 100 /exposure (person-years) Exposure (person-years) = the sum over all participants of the exposure per participant in the 24 months (censored at the time of first occurrence of AE) expressed in days, divided by 365.25. The 24 Month Period includes data up to 56 days post the last dose in the 24 month period. Poisson distribution used to construct the 95% CIs.
Day 1 to Day 729
Proportion of Participants Without Radiographic Progression in Total Score Less Than or Equal to the Smallest Detectable Change (SDC) From Baseline to Months 12 and 24 Using Modified Van Der Heijde Total Sharp Score (mSvdHS) - ITT Population
Prazo: Baseline to Day 729
Plain radiographs of hands and feet taken at baseline (BL), Day 365, and Day 729. BL and Day 365 radiographs were re-read concurrent with Day 729 films by readers blinded to sequence and treatment (a second pre-specified reading campaign). SDC defined as amount of change for which anything smaller could not be reliably distinguished from random error in measurement of simultaneously read films. Non-progression defined: change from BL (Day 1, prior to dosing) in total score less than, equal to (<=) SDC(2.2). Proportion n/m (%)=number meeting criteria (n); number analyzed (m). SDC calculated as SD/sqrt(2)*1.96/sqrt(2)with standard deviation (SD) of paired differences of change from BL in total score between 2 readers; squared root(sqrt). mSvdHS=summary of erosion severity in 32 hand and 12 foot joints. Hand joints scored 0 to 5; foot joints 0 to 10 with 0=no erosion and higher numbers indicating greater erosion severity. BL: radiographic data within 14 days or less of first dose.
Baseline to Day 729
Incidence Rate of Serious Adverse Events (SAEs), Serious Infections, Pre-specified Opportunistic Infections, and Discontinuation for Any Cause at 12 Months of Treatment - ITT Population
Prazo: Day 1 to Day 365
Pre-specified opportunistic infections include: pneumonia, tuberculosis, herpes zoster, combined opportunistic infections, all hospitalized infections. Incidence Rate: incidence/100 person-years: numerator was number of unique events within this period (up to 56 days post-last dose of first 12 months or start of first dose of second 12 months); denominator was overall total exposure (person-years) within this period, calculated as sum over all participants of exposure (in days) divided by 365.25. The resulting incidence rate was multiplied by 100 to express rate per 100 person-years. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE is a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.
Day 1 to Day 365
Incidence Rate of Serious Adverse Events (SAEs), Serious Infections, Pre-specified Opportunistic Infections, and Discontinuation for Any Cause at 24 Months of Treatment - ITT Population
Prazo: Day 1 to Day 729
Pre-specified opportunistic infections include: pneumonia, tuberculosis, herpes zoster, combined opportunistic infections, and all hospitalized infections. Incidence Rate: incidence/100 person-years: numerator was number of unique events within this period (up to 56 days post the last dose of the 24 Months period); denominator was overall total exposure (person-years) within this period, which was calculated as the sum over all participants of exposure (in days) divided by 365.25. The resulting incidence rate was multiplied by 100 to express the rate per 100 person-years. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE is a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.
Day 1 to Day 729
Proportion of Participants With Induction of Autoantibodies During the 12 Months and 24 Months Periods - ITT Population
Prazo: Day 1 to Day 729
The induction of autoantibodies was defined as participant's antinuclear antibodies (ANA) or anti-double stranded deoxyribonucleic acid (dsDNA) converting from a negative status at baseline to a positive status at a post-baseline measurement time point (Day 365 or Day 729). Proportion (%) = n/m, where n=number of participants with positive ANA or dsDNA at a time point and m=number of participants who had negative ANA or dsDNA at baseline. Blood samples were first tested for ANA by indirect fluorescent assay using HEp-2 Cell Line Substrate, and when positive, samples were further tested for anti-dsDNA by indirect fluorescent assay using Crithidia Luciliae Substrate.
Day 1 to Day 729

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

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 outubro de 2009

Conclusão Primária (Real)

1 de outubro de 2011

Conclusão do estudo (Real)

1 de novembro de 2012

Datas de inscrição no estudo

Enviado pela primeira vez

29 de junho de 2009

Enviado pela primeira vez que atendeu aos critérios de CQ

29 de junho de 2009

Primeira postagem (Estimativa)

30 de junho de 2009

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

4 de fevereiro de 2014

Última atualização enviada que atendeu aos critérios de controle de qualidade

3 de janeiro de 2014

Última verificação

1 de janeiro de 2014

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • IM101-235

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 .

Ensaios clínicos em Abatacept

Pesquisar ensaios semelhantes

Patrocinadores e Colaboradores

Condições médicas

Intervenções de drogas

CROs by country

CROs in Moldova

Condições

Doenças Raras

Intervenções de drogas

Suplementos Alimentares

Patrocinador / Colaboradores

Localizações

3
Se inscrever