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RESTART C0168Z05 Rheumatoid Arthritis Study

29 de agosto de 2013 actualizado por: Centocor Ortho Biotech Services, L.L.C.

A Phase 4, Multicenter, Open-Label, Assessor-Blinded Switch Study of the Efficacy and Safety of Infliximab (REMICADE) in Patients With Active Rheumatoid Arthritis Who Are Responding Inadequately to Etanercept (ENBREL) or Adalimumab (HUMIRA).

The purpose of this study is to assess the effectiveness of treatment in patients with active rheumatoid arthritis who are having an inadequate response to at least 3 months of treatment with etanercept or adalimumab in addition to methotrexate.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

This is a Phase 4, multi center, open-label, assessor blinded, switch study of infliximab in patients with active rheumatoid arthritis who are receiving methotrexate and are having an inadequate response to their current treatment with etanercept or adalimumab. The last dose of etanercept must have been at least 1 week but not more than 2 weeks prior to the first infliximab study infusion. The last dose of adalimumab must have been administered at least 2 weeks but not more than 4 weeks prior to the first infliximab study infusion. The study will be conducted for 30 weeks and will include 200 patients. All eligible patients will receive 3 mg/kg infliximab infusions (drug given into a vein) at weeks 0, 2, and 6 and every 8 weeks thereafter, if they achieve a European League Against Rheumatism (EULAR) response on their current dose of infliximab. Patients who do not achieve a EULAR response will increase their dose from 3mg/kg to 5 mg/kg at week 14. Patients who do not achieve a EULAR response at week 22 will increase from either 3 mg/kg to 5 mg/kg or from 5mg/kg to 7 mg/kg. The last study infusion will take place at week 22. The last study visit for effectiveness evaluations will take place at week 26. A week 30 follow-up visit will be performed for adverse events and tuberculosis evaluations, health economics assessments, and review of concomitant medications. All patients who end the study early will be required to complete all assessments. Patients will receive 3 mg/kg infliximab infusions at weeks 0, 2, and 6. If patients achieve European League Against Rheumatism (EULAR) response, they will remain on their current dose. Patients who do not demonstrate a EULAR response will increase their infliximab dose from 3 mg/kg to 5 mg/kg at week 14. At week 22, patients will also increase their infliximab dose from 3 mg/kg to 5mg/kg or from 5 mg/kg to 7mg/kg if they do not demonstrate a EULAR response.

Tipo de estudio

Intervencionista

Inscripción (Actual)

203

Fase

  • Fase 4

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
      • Frankfurt, Alemania
      • Holdenfelde, Alemania
      • Leipzig, Alemania
      • Muenchen, Alemania
      • München, Alemania
      • Ratingen, Alemania
  • Austria
      • Graz-Eggenberg, Austria
      • Wien, Austria
  • Canadá
      • Hamilton Ontario, Canadá
    • British Columbia
      • Vancouver, British Columbia, Canadá
    • Manitoba
      • Winnipeg, Manitoba, Canadá
    • Newfoundland and Labrador
      • St. John'S, Newfoundland and Labrador, Canadá
    • Ontario
      • Toronto, Ontario, Canadá
  • España
      • Madrid, España
      • Oviedo, España
      • Santiago De Compostela, España
  • Estados Unidos
    • Alabama
      • Huntsville, Alabama, Estados Unidos
    • Arizona
      • Paradise Valley, Arizona, Estados Unidos
      • Tucson, Arizona, Estados Unidos
    • California
      • Santa Monica, California, Estados Unidos
    • Connecticut
      • Bridgeport, Connecticut, Estados Unidos
    • Delaware
      • Lewes, Delaware, Estados Unidos
    • Florida
      • Boca Raton, Florida, Estados Unidos
      • Palm Harbor, Florida, Estados Unidos
      • Tamarac, Florida, Estados Unidos
      • Vero Beach, Florida, Estados Unidos
    • Georgia
      • Atlanta, Georgia, Estados Unidos
    • Illinois
      • Moline, Illinois, Estados Unidos
      • Springfield, Illinois, Estados Unidos
    • Kentucky
      • Lexington, Kentucky, Estados Unidos
    • Maryland
      • Wheaton, Maryland, Estados Unidos
    • Michigan
      • Saint Clair Shores, Michigan, Estados Unidos
    • Minnesota
      • Eagan, Minnesota, Estados Unidos
    • Missouri
      • Saint Louis, Missouri, Estados Unidos
      • Springfield, Missouri, Estados Unidos
    • New Jersey
      • Berkeley Heights, New Jersey, Estados Unidos
      • Freehold, New Jersey, Estados Unidos
    • New York
      • Albany, New York, Estados Unidos
      • Syracuse, New York, Estados Unidos
    • North Carolina
      • Chapel Hill, North Carolina, Estados Unidos
    • Ohio
      • Columbus, Ohio, Estados Unidos
      • Mayfield, Ohio, Estados Unidos
      • Middleburg Heights, Ohio, Estados Unidos
    • Oklahoma
      • Tulsa, Oklahoma, Estados Unidos
    • Pennsylvania
      • Allentown, Pennsylvania, Estados Unidos
      • Duncansville, Pennsylvania, Estados Unidos
      • Wexford, Pennsylvania, Estados Unidos
    • South Carolina
      • Charleston, South Carolina, Estados Unidos
      • Greenville, South Carolina, Estados Unidos
    • Tennessee
      • Jackson, Tennessee, Estados Unidos
      • Nashville, Tennessee, Estados Unidos
    • Texas
      • Amarillo, Texas, Estados Unidos
      • Dallas, Texas, Estados Unidos
      • Fort Worth, Texas, Estados Unidos
      • Houston, Texas, Estados Unidos
      • Mesquite, Texas, Estados Unidos
      • Temple, Texas, Estados Unidos
      • Tyler, Texas, Estados Unidos
    • Virginia
      • Burke, Virginia, Estados Unidos
      • Reston, Virginia, Estados Unidos
    • Washington
      • Seattle, Washington, Estados Unidos
  • Finlandia
      • Helsinki, Finlandia
  • Francia
      • Bordeaux Cedex, Francia
      • Limoges, Francia
      • Montivilliers, Francia
      • Orleans, Francia
  • Israel
      • Ashkelon, Israel
      • Beer Yaakov, Israel
      • Haifa, Israel
      • Kfar Saba, Israel
      • Ramat Gan, Israel
      • Rehovot, Israel
      • Tel-Aviv, Israel
  • Países Bajos
      • Alkmaar, Países Bajos
  • Reino Unido
      • Leeds, Reino Unido
      • London, Reino Unido
      • Wigan, Reino Unido

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:

  • Patients must have rheumatoid arthritis
  • Patients must have greater than or equal to 6 tender joints and greater than or equal to 6 swollen joints
  • Patients must have inadequate disease response to etanercept or adalimumab
  • Patients must have received etanercept or adalimumab in combination with methotrexate for a minimum of at least 3 months prior to the screening visit. The last dose of etanercept must have been given at least 1 week but not more than 2 weeks prior to first infliximab infusion. The last dose of adalimumab must have been administered at least 2 weeks but not more than 4 weeks prior to first infliximab infusion.

Exclusion Criteria:

  • Patients who have a history of latent or active TB
  • Have inflammatory disease other than rheumatoid arthritis
  • Have had a chronic or recurrent infectious disease.

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 de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Otro: 001
Infliximab3 mg/kg at week 0,2,6; Increase to 5mg/kg or 7 mg/kg based on EULAR response
Biológico: Infliximab
3 mg/kg at week 0,2,6; Increase to 5mg/kg or 7 mg/kg based on EULAR response

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percent of Patients Who Achieved a EULAR (The European League Against Rheumatism) Response at Week 10
Periodo de tiempo: Week 10
Percent of patients who achieved EULAR response at Week 10. EULAR response is defined based on the DAS28 score and the EULAR response criteria (Van Gestel et al, 1996 and 1999). At a given visit, patients with a DAS28 score of ≤ 5.1 are considered EULAR responders if the improvement from baseline in their DAS28 score is greater than 0.6; Or patients with a DAS28 score > 5.1 are considered EULAR responders if the improvement from baseline in their DAS28 score is > 1.2.
Week 10

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percent of Patients Who Acheived EULAR Response at Week 10 and Maintained Through Week 26 Without Infliximab Dose Increase
Periodo de tiempo: Week 26
Percent of patients who achieved EULAR response at Week 10 and maintained through Week 26 without infliximab dose increase
Week 26
Percent of Patients Who Achieved EULAR Response at Week 26, Regardless of EULAR Response Status at Weeks 10, 14, and 22, With or Without Dose Increase Prior to Week 26
Periodo de tiempo: Week 26
Percent of patients who achieved EULAR response at Week 26, regardless of EULAR response status at Weeks 10, 14, and 22, with or without dose increase prior to Week 26
Week 26
Change From Baseline in Physical Function (HAQ)
Periodo de tiempo: Week 10
Change from baseline in physical function (HAQ) at Week 10. HAQ assesses the degree of difficulty a person has in accomplishing tasks. A lower HAQ score indicates less difficulty. Change from baseline is computed as Week 10 value minus baseline value. A negative value in change from baseline indicates an improvement.
Week 10
Change From Baseline in Physical Function (HAQ)
Periodo de tiempo: Week 26
Change from baseline in physical function (HAQ) at Week 26. HAQ assesses the degree of difficulty a person has in accomplishing tasks. A lower HAQ score indicates less difficulty. Change from baseline is computed as Week 26 value minus baseline value. A negative value in change from baseline indicates an improvement.
Week 26
Percent of Patients Who Achieved ACR20 at Week 10
Periodo de tiempo: Week 10
Percent of patients who achieved ACR20 at Week 10. A patient is considered achieving ACR20 if the following two conditions are met: 1) An improvement of ≥ 20% from baseline in both the swollen joint count (66 joints) and tender joint count (68 joints; 2) An improvement of ≥ 20% from baseline in at least 3 of the following 5 assessments:Patient's assessment of pain visual analog scale (VAS), Patient's global assessment of disease activity (VAS), Evaluator's global assessment of disease activity (VAS), Patient's assessment of physical function as measured by the HAQ disability index, and CRP.
Week 10
Percent of Patients Who Achieved ACR20 at Weeks 26.
Periodo de tiempo: Week 26
Percent of patients who achieved ACR20 at Weeks 26. A patient is considered achieving ACR20 if the following two conditions are met: 1) An improvement of ≥ 20% from baseline in both the swollen joint count (66 joints) and tender joint count (68 joints; 2) An improvement of ≥ 20% from baseline in at least 3 of the following 5 assessments:Patient's assessment of pain visual analog scale (VAS), Patient's global assessment of disease activity (VAS), Evaluator's global assessment of disease activity (VAS), Patient's assessment of physical function as measured by the HAQ disability index, and CRP.
Week 26

Colaboradores e Investigadores

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

Patrocinador

Centocor Ortho Biotech Services, L.L.C.

Colaboradores

Schering-Plough

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

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 julio de 2008

Finalización primaria (Actual)

1 de enero de 2010

Finalización del estudio (Actual)

1 de junio de 2010

Fechas de registro del estudio

Enviado por primera vez

10 de julio de 2008

Primero enviado que cumplió con los criterios de control de calidad

11 de julio de 2008

Publicado por primera vez (Estimar)

14 de julio de 2008

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

12 de septiembre de 2013

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

29 de agosto de 2013

Última verificación

1 de agosto de 2013

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CR013879
  • C0168Z05 (Otro identificador: Centocor Ortho Biotech Services, L.L.C.)

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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