- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00349752
Corticosteroid Sparing Effect of Certolizumab in Crohn's Disease (COSPAR1)
10 de julio de 2018 actualizado por: UCB Pharma
A Phase IIIb Multicenter, Double-blind, Placebo-controlled,Randomized Trial to Examine the Corticosteroid-sparing Effect of Certolizumab Pegol in Patients With Moderate to Severe Crohn's Disease.
The current study is designed to measure the corticosteroid-sparing effect of certolizumab pegol using a defined schedule of corticosteroid tapering in subjects with moderate to severe Crohn's disease.
Subjects had to be in remission (CDAI<=150) and receiving corticosteroids at a dose no higher than 30 mg/day prednisone or equivalent during the week prior to randomization.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
174
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
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Frankfurt, Alemania
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Heidleberg, Alemania
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Jena, Alemania
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Magdeburg, Alemania
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Ulm, Alemania
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Alberta
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Calgary, Alberta, Canadá
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Edmonton, Alberta, Canadá
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British Columbia
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Abbotsford, British Columbia, Canadá
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Vancouver, British Columbia, Canadá
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Manitoba
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Winnipeg, Manitoba, Canadá
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Nova Scotia
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Halifax, Nova Scotia, Canadá
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Ontario
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London, Ontario, Canadá
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Toronto, Ontario, Canadá
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Saskatchewan
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Saskatoon, Saskatchewan, Canadá
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Alabama
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Birmingham, Alabama, Estados Unidos
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Montgomery, Alabama, Estados Unidos
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Arizona
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Tucson, Arizona, Estados Unidos
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California
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La Jolla, California, Estados Unidos
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Oceanside, California, Estados Unidos
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Orange, California, Estados Unidos
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Palo Alto, California, Estados Unidos
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Roseville, California, Estados Unidos
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Colorado
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Golden, Colorado, Estados Unidos
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Florida
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Clearwater, Florida, Estados Unidos
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Gainesville, Florida, Estados Unidos
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Hialeah, Florida, Estados Unidos
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Jacksonville, Florida, Estados Unidos
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North Miami Beach, Florida, Estados Unidos
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Sarasota, Florida, Estados Unidos
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Winter Park, Florida, Estados Unidos
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Georgia
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Marietta, Georgia, Estados Unidos
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Savannah, Georgia, Estados Unidos
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Illinois
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Chicago, Illinois, Estados Unidos
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Indiana
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Bloomington, Indiana, Estados Unidos
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Kansas
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Topeka, Kansas, Estados Unidos
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Kentucky
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Bowling Green, Kentucky, Estados Unidos
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Louisville, Kentucky, Estados Unidos
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Louisiana
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Metairie, Louisiana, Estados Unidos
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Maryland
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Annapolis, Maryland, Estados Unidos
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Massachusetts
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Newton, Massachusetts, Estados Unidos
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Michigan
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Chesterfield, Michigan, Estados Unidos
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Dearborn, Michigan, Estados Unidos
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Troy, Michigan, Estados Unidos
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Minnesota
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Rochester, Minnesota, Estados Unidos
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Mississippi
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Ocean Springs, Mississippi, Estados Unidos
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Missouri
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Kansas City, Missouri, Estados Unidos
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Mexico, Missouri, Estados Unidos
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New York
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New York, New York, Estados Unidos
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Syracuse, New York, Estados Unidos
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos
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Charlotte, North Carolina, Estados Unidos
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Raleigh, North Carolina, Estados Unidos
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Ohio
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Cincinnati, Ohio, Estados Unidos
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Cleveland, Ohio, Estados Unidos
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Dayton, Ohio, Estados Unidos
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Oklahoma
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Tulsa, Oklahoma, Estados Unidos
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South Carolina
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Columbia, South Carolina, Estados Unidos
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Tennessee
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Germantown, Tennessee, Estados Unidos
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Texas
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Austin, Texas, Estados Unidos
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Irving, Texas, Estados Unidos
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Utah
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Salt Lake City, Utah, Estados Unidos
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Vermont
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Burlington, Vermont, Estados Unidos
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Virginia
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Chesapeake, Virginia, Estados Unidos
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Richmond, Virginia, Estados Unidos
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Washington
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Seattle, Washington, Estados Unidos
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Wisconsin
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Madison, Wisconsin, Estados Unidos
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Milwaukee, Wisconsin, Estados Unidos
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Monroe, Wisconsin, Estados Unidos
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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 y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Men and women
- Age 18 years or older with moderate to severe Crohn's disease (Crohn's Disease Activity Index (CDAI) score of ≥ 220 ≤450)
Exclusion Criteria:
- Active or draining fistula present at screening
- Lactating and/or pregnant female subjects
- A history of any health condition that could potentially interfere with the disease and/or the treatment
- A history of an adverse reaction to polyethylene glycol (PEG) or a protein medicinal product
- Any other condition which in the Investigator's judgment would make the patient unsuitable for inclusion in the study
- History of drug or alcohol abuse in the prior year
- Receipt of any experimental therapy within or outside a clinical trial in the 3 months prior to Visit 0
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: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador de placebos: Placebo
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Placebo (commercially available sodium chloride 0.9% (preservative free)) provided for subcutaneous injection in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36.
Two vials will be required for each dosing.
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Experimental: Certolizumab pegol 400 mg
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Certolizumab pegol 400 mg provided in solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36.
Two vials will be required for each dosing.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Percentage of Subjects Who Have Been Withdrawn From Prednisone or Prednisolone Therapy According to the Corticosteroid Tapering Schedule and Have Remained Off Corticosteroids and in Disease Remission at Week 38
Periodo de tiempo: Week 38
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The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease.
A CDAI score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease.
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Week 38
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Percentage of Subjects With Continuous Remission Off Steroids at Week 38
Periodo de tiempo: Week 38
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The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease.
A CDAI score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease.
A subject with continuous remission off steroids at Week 38 is a subject in remission (CDAI =< 150) from the visit when he stops taking steroids to Week 38 and is off corticosteroids until Week 38.
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Week 38
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Cumulative Percentage of Subjects With Relapse/Treatment Failure at Week 38
Periodo de tiempo: Week 38
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A subject with relapse/ treatment failure has a Crohn's Disease Activity Index (CDAI) > 150 and an increase in CDAI of >= 70 points versus Week 0. [The CDAI is used to quantify the symptoms of subjects with Crohn's disease.
A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease.]
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Week 38
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Time to Relapse/Treatment Failure During the 38-week Double-blind Treatment Period
Periodo de tiempo: During the 38-week double-blind treatment period
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A subject with relapse/ treatment failure has a Crohn's Disease Activity Index (CDAI) > 150 and an increase in CDAI of >= 70 points versus Week 0. [The CDAI is used to quantify the symptoms of subjects with Crohn's disease.
A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease.]
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During the 38-week double-blind treatment period
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Per-subject Median Weekly Dose of Corticosteroids Over the 38-week Double-blind Treatment Period
Periodo de tiempo: Over the 38-week double-blind treatment period
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The median weekly dose of corticosteroids is calculated for each subject, and these per-subject median values are further summarized by treatment group.
The mean of the per-subject median doses in each treatment group is presented here.
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Over the 38-week double-blind treatment period
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Per-subject Cumulative Dose of Corticosteroids Over the 48-week Study Period
Periodo de tiempo: Over the 48-week study period
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The cumulative dose of corticosteroids over the 48-week study period is calculated for each subject individually.
The mean of these values for each treatment group is presented here.
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Over the 48-week study period
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Change From the 6-week run-in Period in Per-subject Median Weekly Dose of Corticosteroids Over the 38-week Double-blind Treatment Period
Periodo de tiempo: 6-week run-in period, 38-week double-blind treatment period
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The run in period lasted a minimum of 1 week and a maximum of 6 weeks.
During this period subjects were treated with any dose or type of systemic corticosteroids the Investigator felt was appropriate.
To be eligible for study randomization, subjects must have been in remission (CDAI ≤150 points) and receiving corticosteroids at a dose no higher than 30 mg/day prednisone or equivalent during the week prior to randomization.
Subjects who did not meet these criteria were not randomized and were withdrawn from the study.
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6-week run-in period, 38-week double-blind treatment period
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Crohn's Disease Activity Index (CDAI) Score at Week 38
Periodo de tiempo: Week 38
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The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease.
A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease.
A decrease in CDAI over time indicates improvement in disease activity.
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Week 38
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Change From Baseline in CDAI Score at Week 38
Periodo de tiempo: Week 0, Week 38
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The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease.
A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease.
A decrease in CDAI over time indicates improvement in disease activity.
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Week 0, Week 38
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Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 38
Periodo de tiempo: Week 38
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The total IBDQ score will be derived as the sum of the responses (each ranging from 1 to 7) to all 32 questions on the IBDQ and can therefore range from 32 to 224.
A higher score indicates a better quality of life.
IBDQ remission is defined as a subject having an IBDQ total score >= 170 points.
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Week 38
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Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 38
Periodo de tiempo: Week 0, Week 38
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The total IBDQ score will be derived as the sum of the responses (each ranging from 1 to 7) to all 32 questions on the IBDQ and can therefore range from 32 to 224.
A higher scores indicates a better quality of life.
IBDQ response is defined as an increase from baseline in the IBDQ total score >= 16 points.
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Week 0, Week 38
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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.
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 noviembre de 2006
Finalización primaria (Actual)
1 de julio de 2009
Finalización del estudio (Actual)
1 de julio de 2009
Fechas de registro del estudio
Enviado por primera vez
30 de junio de 2006
Primero enviado que cumplió con los criterios de control de calidad
6 de julio de 2006
Publicado por primera vez (Estimar)
10 de julio de 2006
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 2010
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- C87059
- 2006-003870-88 (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. .
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