Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Study to Evaluate Efficacy and Safety of Certolizumab Pegol for Induction of Remission in Patients With Crohn's Disease

10 de julio de 2018 actualizado por: UCB Pharma

Phase IIIb, Multinational, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Certolizumab Pegol, a Pegylated Fab' Fragment of a Humanized Anti-Tumor Necrosis Factor(TNF)-Alpha Monoclonal Antibody, Administered in Subjects With Moderately to Severely Active Crohn's Disease.

The primary objective of the study is to evaluate efficacy of certolizumab pegol in inducing clinical remission in patients with moderate to severe Crohn's disease as compared with placebo based on Crohn's Disease Activity Index (CDAI) score at Week 6.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

439

Fase

  • Fase 3

Acceso ampliado

Disponible fuera del ensayo clínico. Ver registro de acceso ampliado.

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Alemania
      • Berlin, Alemania
      • Frankfurt, Alemania
      • Freiburg, Alemania
      • Homburg, Alemania
      • Jena, Alemania
      • Kiel, Alemania
      • Munchen, Alemania
      • Ulm, Alemania
      • Wilhelmshaven, Alemania
  • Australia
      • Adelaide, Australia
      • Bankstown, Australia
      • Clayton, Australia
      • Fitzroy, Australia
      • Fremantle, Australia
      • Garran, Australia
    • New South Wales
      • Concord, New South Wales, Australia
    • Victoria
      • Box Hill, Victoria, Australia
      • Footscray, Victoria, Australia
      • Parkville, Victoria, Australia
  • Austria
      • Wien, Austria
  • Brasil
      • Curitiba, Brasil
      • Goiania, Brasil
      • Porto Alegre, Brasil
      • Rio de Janeiro, Brasil
      • Santo-Andre, Brasil
      • Santos, Brasil
      • Sao Paulo, Brasil
    • MG
      • Belo-Horizonte, MG, Brasil
  • Bélgica
      • Bonheiden, Bélgica
      • Brussels, Bélgica
      • Gent, Bélgica
      • Leuven, Bélgica
      • Liege, Bélgica
      • Roeselare, Bélgica
  • Canadá
      • Calgary, Canadá
    • Alberta
      • Edmonton, Alberta, Canadá
    • British Columbia
      • Kelowna, British Columbia, Canadá
    • Manitoba
      • Winnipeg, Manitoba, Canadá
    • Ontario
      • Hamilton, Ontario, Canadá
      • Kingston, Ontario, Canadá
      • London, Ontario, Canadá
      • Toronto, Ontario, Canadá
  • Chequia
      • Hradec Kralove, Chequia
      • Hradek Kralove, Chequia
      • Praha 7, Chequia
      • Usti Nad Orlici, Chequia
      • Zlin, Chequia
  • Chile
      • Santiago, Chile
      • Vina del Mar, Chile
  • Estados Unidos
    • Alabama
      • Pell City, Alabama, Estados Unidos
    • Colorado
      • Colorado Springs, Colorado, Estados Unidos
      • Lakewood, Colorado, Estados Unidos
      • Littleton, Colorado, Estados Unidos
    • Florida
      • Hollywood, Florida, Estados Unidos
      • Jacksonville, Florida, Estados Unidos
      • New Port Richey, Florida, Estados Unidos
      • Winter Park, Florida, Estados Unidos
    • Illinois
      • Chicago, Illinois, Estados Unidos
    • Kentucky
      • Louisville, Kentucky, Estados Unidos
    • Louisiana
      • Metairie, Louisiana, Estados Unidos
      • Monroe, Louisiana, Estados Unidos
    • Maryland
      • Annapolis, Maryland, Estados Unidos
      • Towson, Maryland, Estados Unidos
    • Michigan
      • Chesterfield, Michigan, Estados Unidos
      • West Bloomfield, Michigan, Estados Unidos
    • Minnesota
      • Rochester, Minnesota, Estados Unidos
    • North Carolina
      • Raleigh, North Carolina, Estados Unidos
    • Ohio
      • Cincinnati, Ohio, Estados Unidos
      • Cleveland, Ohio, Estados Unidos
    • Pennsylvania
      • Lancaster, Pennsylvania, Estados Unidos
    • Tennessee
      • Germantown, Tennessee, Estados Unidos
    • Virginia
      • Norfolk, Virginia, Estados Unidos
    • Washington
      • Seattle, Washington, Estados Unidos
  • Estonia
      • Tallin, Estonia
      • Tartu, Estonia
  • Federación Rusa
      • Kazan, Federación Rusa
      • Moscow, Federación Rusa
      • St. Petersburg, Federación Rusa
  • Finlandia
      • Mikkeli, Finlandia
  • Hungría
      • Budapest, Hungría
      • Gyor, Hungría
      • Nagykanizsa, Hungría
      • Szeged, Hungría
      • Szombathely, Hungría
  • Israel
      • Beer Sheva, Israel
      • Haifa, Israel
      • Holon, Israel
      • Jerusalem, Israel
      • Kfar Saba, Israel
      • Petha Tikva, Israel
      • Rehovot, Israel
      • Tel Aviv, Israel
      • Zerifin, Israel
  • Italia
      • Bologna, Italia
      • Padova, Italia
      • Roma, Italia
  • Letonia
      • Riga, Letonia
      • Valmiera, Letonia
  • Nueva Zelanda
      • Auckland, Nueva Zelanda
      • Christchurch, Nueva Zelanda
      • Hamilton, Nueva Zelanda
    • Auckland
      • Milford, Auckland, Nueva Zelanda
    • Wellington
      • Newton, Wellington, Nueva Zelanda
  • Polonia
      • Czestochowa, Polonia
      • Lodz, Polonia
      • Warszawa, Polonia
      • Wroclaw, Polonia
  • Rumania
      • Bucharest, Rumania
      • Cluj Napoca, Rumania
      • Constanta, Rumania
  • Ucrania
      • Dniepropetrovsk, Ucrania
      • Donetsk, Ucrania
      • Kiev, Ucrania
      • Kyiv, Ucrania
      • Lviv, Ucrania
      • Simferopol, Ucrania

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 75 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • male/female
  • 18 - 75 years inclusive
  • diagnosis of Crohn's disease confirmed
  • moderate to severe disease activity (Crohn's Disease Activity Index (CDAI) 225 - 450)
  • no previous treatment with anti-tumor necrosis factor (anti-TNF) medications

Exclusion Criteria:

  • previous participation in a certolizumab pegol study
  • general exclusion criteria as common for studies in this indication

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Certolizumab pegol
Certolizumab pegol 400 mg for subcutaneous (sc) injection
Biológico: certolizumab pegol (CDP870, CZP)
Certolizumab Pegol 400 mg CZP sc injection 2 x 1 mL CZP (200 mg/mL) at Week 0, 2, and 4
Otros nombres:
  • CZP
  • CDP870
  • CIMZIA ®
Comparador de placebos: Placebo
Placebo, saline solution for sc injection
Otro: Placebo
Saline 0.9% sc injection 2 x 1 mL Placebo at Week 0, 2 and 4

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Subjects in Clinical Remission at Week 6
Periodo de tiempo: Week 6
The percentage of subjects in clinical remission at Week 6 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Week 6

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Subjects Achieving a Clinical Response at Week 6
Periodo de tiempo: Week 0, Week 6
The percentage of subjects achieving a clinical response at Week 6 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Week 0, Week 6
Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 6
Periodo de tiempo: Week 6
The percentage of subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 6 (IBDQ remission is defined as a total IBDQ score of 170 points or more). The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.
Week 6
Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 6
Periodo de tiempo: Week 0 to Week 6
The change in total Crohn's Disease Activity Index (CDAI) score from Week 0 to Week 6. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Week 0 to Week 6
Change in Harvey Bradshaw Index (HBI) Score From Week 0 to Week 6
Periodo de tiempo: Week 0 to Week 6
The change in Harvey Bradshaw Index (HBI) score from Week 0 to Week 6. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (score 1 per item). The first three items are scored for the previous day. Lower scores indicated better well being.
Week 0 to Week 6
Percentage of Subjects in Clinical Remission at Week 2
Periodo de tiempo: Week 2
The percentage of subjects in clinical remission at Week 2 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Week 2
Percentage of Subjects in Clinical Remission at Week 4
Periodo de tiempo: Week 4
The percentage of subjects in clinical remission at Week 4 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Week 4
Percentage of Subjects Achieving a Clinical Response at Week 2
Periodo de tiempo: Week 0, Week 2
The percentage of subjects achieving a clinical response at Week 2 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Week 0, Week 2
Percentage of Subjects Achieving a Clinical Response at Week 4
Periodo de tiempo: Week 0, Week 4
The percentage of subjects achieving a clinical response at Week 4 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Week 0, Week 4
Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 2
Periodo de tiempo: Week 0 to Week 2
The change in total Crohn's Disease Activity Index (CDAI) score from Week 0 to Week 2. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Week 0 to Week 2
Change in Total Crohn's Disease Activity Index (CDAI) Score From Week 0 to Week 4
Periodo de tiempo: Week 0, Week 4
The change in total Crohn's Disease Activity Index (CDAI) score from Week 0 to Week 4. CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Week 0, Week 4
Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 2
Periodo de tiempo: Week 2
The percentage of subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 2 (IBDQ remission is defined as a total IBDQ score of 170 points or more). The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.
Week 2
Percentage of Subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 4
Periodo de tiempo: Week 4
The percentage of subjects in Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 4 (IBDQ remission is defined as a total IBDQ score of 170 points or more). The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.
Week 4
Percentage of Subjects in Subgroup With Less Than 10 mg/L C-reactive Protein (CRP) at Entry Who Are in Clinical Remission at Week 6
Periodo de tiempo: Week 6
The percentage of subjects in the subgroup with less than 10 mg/L of C-reactive Protein (CRP) at Entry who are in clinical remission at Week 6 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Week 6
Percentage of Subjects in Subgroup With 10 mg/L or Greater C-reactive Protein (CRP) at Entry Who Are in Clinical Remission at Week 6
Periodo de tiempo: Week 6
The percentage of subjects in the subgroup with 10 mg/L or greater C-reactive Protein (CRP) at Entry in clinical remission at Week 6 (clinical remission is defined as a total Crohn's Disease Activity Index (CDAI) score of 150 points or less). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Week 6
Percentage of Subjects in Subgroup With Less Than 10 mg/L C-reactive Protein (CRP) at Entry Achieving a Clinical Response at Week 6
Periodo de tiempo: Week 0, Week 6
The percentage of subjects in the subgroup with less than 10 mg/L C-reactive Protein (CRP) at Entry achieving a clinical response at Week 6 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Week 0, Week 6
Percentage of Subjects in Subgroup With 10 mg/L or Greater C-reactive Protein (CRP) at Entry Achieving a Clinical Response at Week 6
Periodo de tiempo: Week 0, Week 6
The percentage of subjects in the subgroup with 10 mg/L or greater C-reactive Protein (CRP) at Entry achieving a clinical response at Week 6 (clinical response is defined as at least a 100-point decrease from the Week 0 Crohn's Disease Activity Index (CDAI) score). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 points or below indicates clinical remission and a score above 450 points indicates extremely severe disease.
Week 0, Week 6

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

UCB Pharma

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de marzo de 2008

Finalización primaria (Actual)

1 de octubre de 2009

Finalización del estudio (Actual)

1 de noviembre de 2009

Fechas de registro del estudio

Enviado por primera vez

18 de octubre de 2007

Primero enviado que cumplió con los criterios de control de calidad

31 de octubre de 2007

Publicado por primera vez (Estimar)

1 de noviembre de 2007

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

9 de agosto de 2018

Última actualización enviada que cumplió con los criterios de control de calidad

10 de julio de 2018

Última verificación

1 de octubre de 2011

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • C87085
  • 2007-001913-41 (Número EudraCT)

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Enfermedad de Crohn

Ensayos clínicos sobre certolizumab pegol (CDP870, CZP)

Buscar ensayos similares

Patrocinadores y Colaboradores

Condiciones médicas

Intervenciones de drogas

CROs by country

CROs in Moldova

Condiciones

Enfermedades Raras

Intervenciones de drogas

Suplementos dietéticos

Patrocinador / Colaboradores

Localizaciones

3
Suscribir