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Study of Vedolizumab in Patients With Moderate to Severe Crohn's Disease (GEMINI III)

19 de junho de 2014 atualizado por: Millennium Pharmaceuticals, Inc.

A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn's Disease

This study in patients with moderately to severely active Crohn's disease is designed to establish the efficacy and safety of vedolizumab for the induction of clinical response and remission.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

After completing the study, patients were eligible to enroll in a long term safety study with continued access to vedolizumab (study C13008; NCT00790933) if study drug was well tolerated, and no major surgical intervention for Crohn's disease occurred or was required.

Participants who did not enroll in Study C13008 were to complete the Final Safety visit (16 weeks after the last dose of study drug) for a maximum time on study of 22 weeks.

Tipo de estudo

Intervencional

Inscrição (Real)

416

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

  • Canadá
    • Alberta
      • Edmonton, Alberta, Canadá, T6G2X8
        • Zeidler Ledcor Center-Univerisity of Alberta
  • Estados Unidos
    • Colorado
      • Lafayette, Colorado, Estados Unidos, 80026
        • Gastroenterology of the Rockies
    • Connecticut
      • Hamden, Connecticut, Estados Unidos, 65180
        • Gastroenterology Center of Connecticut P.C.
    • Florida
      • Gainesville, Florida, Estados Unidos, 32610
        • University of Florida
      • Miami, Florida, Estados Unidos, 33136
        • University of Miami Miller School of Medicine
      • Winter Park, Florida, Estados Unidos, 32789
        • Shafran Gastroenterology Center
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30342
        • Atlanta Gastroenterology Associates
      • Macon, Georgia, Estados Unidos, 31201
        • Gastroenterology Associates of Central Georgia
      • Suwanee, Georgia, Estados Unidos, 30024
        • Atlanta Gastroenterology Specialist PC
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60637
        • University of Chicago Medical Center
    • Kansas
      • Topeka, Kansas, Estados Unidos, 66606
        • Cotton O'Neil Digestive Health Center
    • Kentucky
      • Lexington, Kentucky, Estados Unidos, 40536
        • University of Kentucky Medical Center
      • Louisville, Kentucky, Estados Unidos, 40402
        • University of Louisville
    • Louisiana
      • Baton Rouge, Louisiana, Estados Unidos, 70809
        • Gastroenterology Associates
      • Hammond, Louisiana, Estados Unidos, 70403
        • Gastroenterology Research Of New Orleans
    • Maryland
      • Chevy Chase, Maryland, Estados Unidos, 20815
        • Metropolitan Gastroenterology Group P.C.
      • Hollywood, Maryland, Estados Unidos, 20636
        • Mid-Atlantic Medical Research Center
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02114
        • Massachusetts General Hospital Crohn's and Colitis Center
    • Michigan
      • Ann Arbor, Michigan, Estados Unidos, 48109
        • University of Michigan
      • Troy, Michigan, Estados Unidos, 48098
        • Center for Digestive Health
      • Ypsilanti, Michigan, Estados Unidos, 48197
        • Huron Gastroenterology Associates
    • Minnesota
      • Plymouth, Minnesota, Estados Unidos, 55446
        • Minnesota Gastroenterology P.A.
      • Rochester, Minnesota, Estados Unidos, 55905
        • Mayo Clinic
    • Missouri
      • St. Louis, Missouri, Estados Unidos, 63110
        • Washington University
    • New Hampshire
      • Lebanon, New Hampshire, Estados Unidos, 03756
        • Dartmouth-Hitchcock Medical Center
    • New York
      • Great Neck, New York, Estados Unidos, 11021
        • Long Island Clinical Research Associates
      • New York, New York, Estados Unidos, 10021
        • New York Presbyterian Hospital
      • Rochester, New York, Estados Unidos, 14642
        • University of Rochester
    • North Carolina
      • Chapel Hill, North Carolina, Estados Unidos, 27599
        • University of North Carolina at Chapel Hill
      • Charlotte, North Carolina, Estados Unidos, 28207
        • Charlotte Gastroenterology and Hepatology P.L.L.C
    • Ohio
      • Cincinnati, Ohio, Estados Unidos, 45219
        • Consultants for Clinical Research Inc.
    • Oklahoma
      • Tulsa, Oklahoma, Estados Unidos, 74104
        • Options Health Research
    • Oregon
      • Portland, Oregon, Estados Unidos, 97225
        • The Oregon Clinic-West Hills Gastroenterology
    • South Carolina
      • Columbia, South Carolina, Estados Unidos, 29203
        • Consultants in Gastroenterology
    • Tennessee
      • Germantown, Tennessee, Estados Unidos, 38138
        • Gastroenterology Center of the MidSouth PC
    • Texas
      • San Antonio, Texas, Estados Unidos, 78229
        • Gastroenterology Clinic of San Antonio
      • Tyler, Texas, Estados Unidos, 75701
        • Digestive Health Specialists of Tyler
    • Virginia
      • Charlottesville, Virginia, Estados Unidos, 22908
        • University of Virginia Health System
    • Washington
      • Seattle, Washington, Estados Unidos, 98195
        • University of Washington School of Medicine
    • Wisconsin
      • Milwaukee, Wisconsin, Estados Unidos, 53226
        • Medical College of Wisconsin
      • Milwaukee, Wisconsin, Estados Unidos, 53215
        • Wisconsin Center for Advanced Research

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 80 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Age 18 to 80
  • Diagnosis of moderately to severely active Crohn's disease
  • Crohn's Disease involvement of the ileum and/or colon
  • Demonstrated, over the previous 5 year period, an inadequate response to, loss of response to, or intolerance of at least one conventional therapy as defined by the protocol
  • May be receiving a therapeutic dose of conventional therapies for inflammatory bowel disease (IBD) as defined by the protocol

Exclusion Criteria

  • Evidence of abdominal abscess at the initial screening visit
  • Extensive colonic resection, subtotal or total colectomy
  • History of >3 small bowel resections or diagnosis of short bowel syndrome
  • Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine
  • Have received non permitted therapies within either 30 or 60 days, depending on the medication, as stated in the protocol
  • Chronic hepatitis B or C infection; human immunodeficiency virus (HIV) infection
  • Active or latent tuberculosis

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: Triplo

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador de Placebo: Placebo
Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
Outro: Placebo
Infusão intravenosa de placebo
Experimental: Vedolizumab
Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
Medicamento: vedolizumabe
Vedolizumabe para infusão intravenosa
Outros nomes:
  • Entyvio
  • MLN0002
  • MLN02
  • LDP-02

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Percentage of Participants in Clinical Remission in the Tumor Necrosis Factor Alpha (TNFα) Antagonist Failure Subpopulation
Prazo: Week 6

Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points.

The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:

  • Number of liquid or soft stools each day for 7 days;
  • Abdominal pain (graded from 0-3 on severity) each day for 7 days;
  • General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;
  • Presence of complications;
  • Taking Lomotil or opiates for diarrhea;
  • Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);
  • Hematocrit of < 0.47 in men and < 0.42 in women;
  • Percentage deviation from standard weight.

The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.

All participants who prematurely discontinued for any reason were considered as not achieving clinical remission.
Week 6

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Percentage of Participants in Clinical Remission at Week 6 in the Overall Population
Prazo: Week 6

Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points.

The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:

  • Number of liquid or soft stools each day for 7 days;
  • Abdominal pain (graded from 0-3 on severity) each day for 7 days;
  • General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;
  • Presence of complications;
  • Taking Lomotil or opiates for diarrhea;
  • Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);
  • Hematocrit of < 0.47 in men and < 0.42 in women;
  • Percentage deviation from standard weight.

The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.

All participants who prematurely discontinued for any reason were considered as not achieving clinical remission.
Week 6
Percentage of Participants in Clinical Remission at Week 10 in the TNFα Antagonist Failure Subpopulation
Prazo: Week 10

Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points.

The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:

  • Number of liquid or soft stools each day for 7 days;
  • Abdominal pain (graded from 0-3 on severity) each day for 7 days;
  • General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;
  • Presence of complications;
  • Taking Lomotil or opiates for diarrhea;
  • Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);
  • Hematocrit of < 0.47 in men and < 0.42 in women;
  • Percentage deviation from standard weight.

The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.

All participants who prematurely discontinued for any reason were considered as not achieving clinical remission.
Week 10
Percentage of Participants in Clinical Remission at Week 10 in the Overall Population
Prazo: Week 10

Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points.

The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:

  • Number of liquid or soft stools each day for 7 days;
  • Abdominal pain (graded from 0-3 on severity) each day for 7 days;
  • General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;
  • Presence of complications;
  • Taking Lomotil or opiates for diarrhea;
  • Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);
  • Hematocrit of < 0.47 in men and < 0.42 in women;
  • Percentage deviation from standard weight.

The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.

All participants who prematurely discontinued for any reason were considered as not achieving clinical remission.
Week 10
Percentage of Participants With Sustained Clinical Remission in the TNFα Antagonist Failure Population
Prazo: Week 6 and Week 10

Sustained clinical remission is defined as a CDAI score ≤ 150 points at both Week 6 and Week 10. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:

  • Number of liquid or soft stools each day for 7 days;
  • Abdominal pain (graded from 0-3 on severity) each day for 7 days;
  • General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;
  • Presence of complications;
  • Taking Lomotil or opiates for diarrhea;
  • Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);
  • Hematocrit of < 0.47 in men and < 0.42 in women;
  • Percentage deviation from standard weight.

The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.

All participants who prematurely discontinued for any reason were considered as not achieving sustained clinical remission.
Week 6 and Week 10
Percentage of Participants With Sustained Clinical Remission in the Overall Population
Prazo: Week 6 and Week 10

Sustained clinical remission is defined as a CDAI score ≤ 150 points at both Week 6 and Week 10. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:

  • Number of liquid or soft stools each day for 7 days;
  • Abdominal pain (graded from 0-3 on severity) each day for 7 days;
  • General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;
  • Presence of complications;
  • Taking Lomotil or opiates for diarrhea;
  • Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);
  • Hematocrit of < 0.47 in men and < 0.42 in women;
  • Percentage deviation from standard weight.

The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.

All participants who prematurely discontinued for any reason were considered as not achieving sustained clinical remission.
Week 6 and Week 10
Percentage of Participants With Enhanced Clinical Response at Week 6 in the TNFα Antagonist Failure Subpopulation
Prazo: Baseline and Week 6

Enhanced clinical response is defined as a ≥ 100-point decrease in CDAI score from Baseline.

The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are:

  • Number of liquid or soft stools each day for 7 days;
  • Abdominal pain (graded from 0-3 on severity) each day for 7 days;
  • General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days;
  • Presence of complications;
  • Taking Lomotil or opiates for diarrhea;
  • Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite);
  • Hematocrit of < 0.47 in men and < 0.42 in women;
  • Percent deviation from standard weight.

The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity.

All participants who prematurely discontinued for any reason were considered as not achieving enhanced clinical response.
Baseline and Week 6
Number of Participants With Adverse Events (AEs)
Prazo: From the date of first study drug administration to Week 22, through the 14 March 2012 database lock date. At the time of this database lock, 7 patients had completed Week 10 or early termination assessments but not Week 22 assessments.

An AE was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, which did not necessarily have a causal relationship with the treatment. A serious adverse event (SAE) was any AE, occurring at any dose and regardless of causality that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was an important medical event based upon appropriate medical judgment that may have jeopardized the patient and may have required medical or surgical intervention to prevent 1 of the outcomes listed above, or any diagnosis of progressive multifocal leukoencephalopathy (PML).

Relationship to study drug administration was determined by the investigator responding yes or no to the question: Is there a reasonable possibility that the AE is associated with the study drug?
From the date of first study drug administration to Week 22, through the 14 March 2012 database lock date. At the time of this database lock, 7 patients had completed Week 10 or early termination assessments but not Week 22 assessments.

Colaboradores e Investigadores

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

Patrocinador

Millennium Pharmaceuticals, Inc.

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 novembro de 2010

Conclusão Primária (Real)

1 de fevereiro de 2012

Conclusão do estudo (Real)

1 de abril de 2012

Datas de inscrição no estudo

Enviado pela primeira vez

18 de outubro de 2010

Enviado pela primeira vez que atendeu aos critérios de CQ

18 de outubro de 2010

Primeira postagem (Estimativa)

19 de outubro de 2010

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

21 de julho de 2014

Última atualização enviada que atendeu aos critérios de controle de qualidade

19 de junho de 2014

Última verificação

1 de junho de 2014

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • C13011
  • U1111-1158-2581 (Identificador de registro: WHO)
  • 2009-016488-12 (Número EudraCT)
  • NL34356.078.10 (Identificador de registro: CCMO)

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Não

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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