- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00265122
A Study of the Safety and Efficacy of Ustekinumab (CNTO 1275) in Participants With Crohn's Disease
20 de enero de 2014 actualizado por: Centocor, Inc.
A Multicenter, Randomized, Phase 2a Study of Human Monoclonal Antibody to IL-12p40 (CNTO 1275) in Subjects With Moderately to Severely Active Crohn's Disease
The purpose of this study is to examine the safety and efficacy of CNTO 1275 in participants with active Crohn's Disease.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a multicenter, randomized study of IL-12p40 (CNTO 1275), hereafter referred to as ustekinumab, in 2 populations of participants with moderately to severely active Crohn's disease of at least 6 weeks duration.
A total of approximately 120 volunteers will participate in this study in Canada, Belgium, and the United States.
Two separate groups of participants (Population 1 and Population 2) will be evaluated.
The primary population of participants (Population 1) will consist of approximately 100 participants with Crohn's disease despite treatment with standard Crohn's disease medications (includes agents to decrease intestinal inflammation such as 5-ASA medications such as PENTASA, ASACOL), corticosteroids such as prednisone and/or other drugs known to suppress the immune system called immunomodulators such as azathioprine, 6-mercaptopurine, methotrexate, infliximab or adalimumab [marketed under the trade name of HUMMIRA]).
Participants in Population 1 will be randomly assigned (assigned by chance, like "flipping a coin") to double-blind treatment (participants and study staff will not know the identity of the treatments) with ustekinumab and placebo (inactive substance) in 1 of 4 treatment groups as follows: (1) 4 weeks of treatment with ustekinumab 90 mg followed by 4 weeks of treatment with placebo injected subcutaneously (SC, under the skin), (II) 4 weeks of placebo followed by 4 weeks of ustekinumab 90 mg injected SC, (III) 1 intravenous (IV, in the vein) infusion of ustekinumab 4.5 mg/kg followed by 1 IV infusion of placebo, and (IV) 1 IV infusion of placebo followed by 1 IV infusion of ustekinumab 4.5 mg/kg.
Population 2 consists of approximately 20 participants who failed to respond to previous therapy with infliximab (trade name REMICADE), a type of antibody that decreases inflammation in patients with moderate to severe Crohn's disease).
All participants in Population 2 will receive open-label (un-blinded) treatment with ustekinumab 4.5 mg/kg administered SC for 4 weeks or as one IV infusion.
Placebo will not be given to participants in Population 2. The duration of the study for each participant is 28 weeks (not including a screening period of up to 2 weeks) with participants returning at Week 54 to have blood samples collected to assess the concentration of ustekinumab and antibodies to ustekinumab.
Adverse events (side-effects) as a measure of safety and tolerability and results from routine laboratory tests will be monitored and reported throughout the study from the time that informed consent is documented up to 3 days after the final blood sample collection at Week 54.
Note: doses of ustekinumab used in the study were adjusted by a factor of 0.9 to be consistent with the corrected absorptivity constant for ustekinumab.
Therefore, ustekinumab doses of 100 mg and 5 mg/kg previously stated in the study protocol have been restated as 90 mg and 4.5 mg/kg, respectively.
No change was made to the amount of ustekinumab given to participants in this study.
Tipo de estudio
Intervencionista
Inscripción (Actual)
131
Fase
- Fase 2
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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Leuven, Bélgica
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Hamilton, Canadá
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London, Canadá
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Alberta
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Edmonton, Alberta, Canadá
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British Columbia
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Vancouver, British Columbia, Canadá
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Manitoba
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Winnipeg, Manitoba, Canadá
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Ontario
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Toronto, Ontario, Canadá
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Arizona
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Scottsdale, Arizona, Estados Unidos
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California
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Anaheim, California, Estados Unidos
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Sacramento, California, Estados Unidos
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San Francisco, California, Estados Unidos
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Connecticut
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Bristol, Connecticut, Estados Unidos
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New Haven, Connecticut, Estados Unidos
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Florida
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Jacksonville, Florida, Estados Unidos
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Miami, Florida, Estados Unidos
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Indiana
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Indianapolis, 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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Lexington, Kentucky, Estados Unidos
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Louisville, Kentucky, Estados Unidos
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Louisiana
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Baton Rouge, Louisiana, Estados Unidos
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Metairie, Louisiana, Estados Unidos
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New Orleans, Louisiana, Estados Unidos
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Maryland
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Laurel, Maryland, Estados Unidos
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Michigan
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Chesterfield, 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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Nebraska
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Omaha, Nebraska, Estados Unidos
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New York
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Great Neck, New York, Estados Unidos
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New York, 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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Ohio
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Cincinnati, Ohio, Estados Unidos
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Cleveland, Ohio, Estados Unidos
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Columbus, Ohio, Estados Unidos
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos
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Oregon
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Portland, Oregon, Estados Unidos
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Pennsylvania
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Beaver Falls, Pennsylvania, Estados Unidos
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Pittsburgh, Pennsylvania, Estados Unidos
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Rhode Island
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Providence, Rhode Island, 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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Knoxville, Tennessee, Estados Unidos
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Memphis, Tennessee, Estados Unidos
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Nashville, Tennessee, Estados Unidos
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Texas
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Austin, Texas, Estados Unidos
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Dallas, Texas, Estados Unidos
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Houston, Texas, Estados Unidos
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Utah
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Ogden, Utah, Estados Unidos
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Salt Lake City, Utah, Estados Unidos
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Virginia
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Charlottesville, Virginia, Estados Unidos
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Christiansburg, Virginia, Estados Unidos
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Richmond, Virginia, Estados Unidos
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Washington
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Everett, Washington, Estados Unidos
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Seattle, Washington, Estados Unidos
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Tacoma, 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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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:
- Have moderately to severly active Crohn's disease or fistulizing Crohn's disease for at least 6 weeks' duration with a Crohn's disease activity index (CDAI) score of >=220 and <=450
- In Population 1, participants must have had active disease despite treatment with 5-ASA compounds, antibiotics, corticosteroids, and/or immunomodulators, including anti-TNF agents. In Population 2, participants must have had active disease and have failed to respond to infliximab at the maximum approved dose and treatment regimen for Crohn's disease as defined in the US package insert.
Exclusion Criteria:
- Have local manifestations of Crohn's disease such as strictures, abscesses, or other disease complications for which surgery might be indicated
- Had intra-abdominal surgery within 6 months prior to entering the study
- Have received treatment with parenteral nutrition (ie, introduction of nutrition into the body via a route other than the mouth) (total parenteral nutrition [TPN]) within 6 weeks of baseline
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: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Population 1: Placebo SC followed by ustekinumab SC
Placebo injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by ustekinumab 90 mg SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.
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one 90 mg SC injection each week for 4 weeks (Weeks 0-3 during Intervention Period 1 or Weeks 8-11 during Intervention Period 2 for Population 1 or Weeks 0-3 during Intervention Period 1 for Population 2)
Otros nombres:
one SC injection each week for 4 weeks (Weeks 0-3 in Intervention Period 1 or Weeks 8-11 in Intervention Period 2 for Population 1 or at Weeks 0-3 in Intervention Period 1 for Population 2)
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Experimental: Population 1: Ustekinumab SC followed by Placebo SC:
Ustekinumab 90 mg injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by ustekinumab 90 mg SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.
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one 90 mg SC injection each week for 4 weeks (Weeks 0-3 during Intervention Period 1 or Weeks 8-11 during Intervention Period 2 for Population 1 or Weeks 0-3 during Intervention Period 1 for Population 2)
Otros nombres:
one SC injection each week for 4 weeks (Weeks 0-3 in Intervention Period 1 or Weeks 8-11 in Intervention Period 2 for Population 1 or at Weeks 0-3 in Intervention Period 1 for Population 2)
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Experimental: Population 1: Placebo IV followed by ustekinumab IV
Placebo given as 1 intravenous (IV) infusion at Week 0 during Intervention Period 1 and ustekinumab 4.5 mg/kg given as one IV infusion at Week 8 during Intervention Period 2.
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one IV infusion of 4.5 mg/kg over a period of not less than 2 hours at Week 0 in Intervention Period 1 or Week 8 in Intervention Period 2 for Population 1 or at Week 0 in Intervention Period 1 for Population 2
Otros nombres:
one IV infusion over a period of not less than 2 hours at Week 0 in Intervention Period 1 for Population 1 and Population 2 or at Week 8 in Intervention Period 2 for Population 1
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Experimental: Population 1: Ustekinumab IV followed by Placebo IV:
Ustekinumab 4.5 mg/kg given as one intravenous(IV) infusion at Week 0 during Intervention Period 1 followed by placebo given as one IV infusion at Week 8 during Intervention Period 2.
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one IV infusion of 4.5 mg/kg over a period of not less than 2 hours at Week 0 in Intervention Period 1 or Week 8 in Intervention Period 2 for Population 1 or at Week 0 in Intervention Period 1 for Population 2
Otros nombres:
one IV infusion over a period of not less than 2 hours at Week 0 in Intervention Period 1 for Population 1 and Population 2 or at Week 8 in Intervention Period 2 for Population 1
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Experimental: Population 2: Ustekinumab SC
Ustekinumab 90 mg injected subcutaneously (SC) once a week at Weeks 0-3 during Intervention Period 1.
No intervention given during Intervention Period 2.
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one 90 mg SC injection each week for 4 weeks (Weeks 0-3 during Intervention Period 1 or Weeks 8-11 during Intervention Period 2 for Population 1 or Weeks 0-3 during Intervention Period 1 for Population 2)
Otros nombres:
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Experimental: Population 2: Ustekinumab IV
Ustekinumab 4.5 mg given as one intravenous (IV) infusion at Week 0 during Intervention Period 1.
No intervention given during Intervention Period 2.
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one IV infusion of 4.5 mg/kg over a period of not less than 2 hours at Week 0 in Intervention Period 1 or Week 8 in Intervention Period 2 for Population 1 or at Week 0 in Intervention Period 1 for Population 2
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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Number of Participants in Population 1 With a Clinical Response at Week 8
Periodo de tiempo: Week 8
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The table below provides the number of participants in Population 1 with a clinical response at Week 8 defined as a reduction from baseline in the CDAI (Crohn's disease activity index) score of >= 25% and >= 70 points at Week 8.
A reduction in CDAI score correlates with improvement in the severity of illness.
The CDAI is derived as a weighted sum of 8 different Crohn's disease related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools (or bags emptied for participants with a stoma), abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well being.
The primary endpoint analysis was based on the comparison between the combined SC and IV Placebo and combined SC and IV ustekinumab treatment groups in Population 1.
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Week 8
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Number of Participants in Population 2 With a Clinical Response at Week 8
Periodo de tiempo: Week 8
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The table below provides the number of participants in Population 2 with a clinical response at Week 8 defined as a reduction from baseline in the CDAI (Crohn's disease activity index) score of >= 25% and >= 70 points at Week 8.
A reduction in CDAI score correlates with improvement in the severity of illness.
The CDAI is derived as a weighted sum of 8 different Crohn's disease related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools (or bags emptied for participants with a stoma), abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being.
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Week 8
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Number of Participants in Population 1 With Clinical Remission at Week 8
Periodo de tiempo: Week 8
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The table below shows the number of participants in Population 1 with clinical remission at Week 8 defined a CDAI (Crohn's disease activity index) score < 150 points at Week 8.
A reduction in CDAI score correlates with improvement in the severity of illness.
The CDAI is derived as a weighted sum of 8 different Crohn's disease related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools (or bags emptied for participants with a stoma), abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being.
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Week 8
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Centocor Clinical Trial, Centocor, Inc.
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
- Ghosh S, Gensler LS, Yang Z, Gasink C, Chakravarty SD, Farahi K, Ramachandran P, Ott E, Strober BE. Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and Crohn's Disease: An Integrated Analysis of Phase II/III Clinical Development Programs. Drug Saf. 2019 Jun;42(6):751-768. doi: 10.1007/s40264-019-00797-3. Erratum In: Drug Saf. 2019 Apr 22;:
- Sandborn WJ, Feagan BG, Fedorak RN, Scherl E, Fleisher MR, Katz S, Johanns J, Blank M, Rutgeerts P; Ustekinumab Crohn's Disease Study Group. A randomized trial of Ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with moderate-to-severe Crohn's disease. Gastroenterology. 2008 Oct;135(4):1130-41. doi: 10.1053/j.gastro.2008.07.014. Epub 2008 Jul 17.
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 abril de 2004
Finalización primaria (Actual)
1 de noviembre de 2005
Finalización del estudio (Actual)
1 de octubre de 2006
Fechas de registro del estudio
Enviado por primera vez
13 de diciembre de 2005
Primero enviado que cumplió con los criterios de control de calidad
13 de diciembre de 2005
Publicado por primera vez (Estimar)
14 de diciembre de 2005
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
13 de febrero de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
20 de enero de 2014
Última verificación
1 de enero de 2014
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CR005287
- C0379T07 (Otro identificador: Centocor, Inc.)
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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