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A Golimumab Phase 3b, Multicenter, Assessment of Intravenous Efficacy in Rheumatoid Arthritis Subjects Who Have Diminished Disease Control Despite Treatment With Infliximab (REMICADE®) (REGAIN)

1 de marzo de 2017 actualizado por: Janssen Biotech, Inc.

This is a Phase 3b, multicenter study of the efficacy of golimumab 2 mg/kg IV in subjects with active rheumatoid arthritis who are receiving methotrexate and have inadequate disease control (defined as an erythrocyte sedimentation rate [ESR]-based Disease Activity Score in 28 joints [DAS28] ≥ 3.2 and ≥ 4 swollen and ≥ 4 tender joints) despite current anti-TNFα therapy with infliximab 2 - 4 mg/kg every 4 weeks, 2 - 5 mg/kg every 5 weeks, 3 - 6 mg/kg every 6 weeks, 3 - 7mg/kg every 7 weeks, or 4 - 8 mg/kg every 8 weeks.

To be eligible for participation, subjects must have previously demonstrated initial and/or temporary improvement in disease signs and symptoms, who have since exhibited a diminished response despite continued treatment. It is estimated that 200 subjects will be enrolled in the study at approximately 85 global sites.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

The study employs an open-label "active switch" design that moves subjects from infliximab to golimumab 2 mg/kg IV. In general, subjects eligible for the study include men or women who are currently receiving infliximab in actual clinical practice who are at least 18 years of age with active rheumatoid arthritis, and have previously demonstrated initial and/or temporary improvement in disease signs and symptoms, but now exhibit a diminished response and inadequate disease control despite continued treatment. Subjects must have received infliximab in combination with methotrexate for a minimum of 9 months prior to the first screening visit.

The screening visit will occur sometime between Week -12 and Week -10. Consenting subjects who meet screening criteria will receive their final dose of infliximab at Week -8 as part of actual clinical practice. Golimumab IV treatment, which will be supplied by the sponsor, will be received at Weeks 0, 4, 12, 20, and 28. The primary endpoint is at Week 24, the final efficacy assessment is at Week 32, and a follow-up safety assessment by telephone is at Week 44. There will be a maximum of 36 weeks between the last infliximab infusion at Week -8 and the last infusion of golimumab at Week 28. The duration of study participation is expected to be a maximum of 56 weeks (including the Screening Period, 32 weeks of golimumab treatment and assessment, and a 12-week safety follow-up).

Tipo de estudio

Intervencionista

Inscripción (Actual)

7

Fase

  • Fase 3

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

  • Canadá
      • Rimouski, Canadá
    • British Columbia
      • Victoria, British Columbia, Canadá
    • Newfoundland and Labrador
      • Saint-John'S, Newfoundland and Labrador, Canadá
      • St. John'S, Newfoundland and Labrador, Canadá
    • Ontario
      • Hamilton, Ontario, Canadá
    • Quebec
      • Montreal, Quebec, Canadá
  • Estados Unidos
    • Alabama
      • Birmingham, Alabama, Estados Unidos
      • Huntsville, Alabama, Estados Unidos
    • Arizona
      • Peoria, Arizona, Estados Unidos
      • Phoenix, Arizona, Estados Unidos
    • Arkansas
      • Fort Smith, Arkansas, Estados Unidos
    • California
      • Fremont, California, Estados Unidos
      • Fullerton, California, Estados Unidos
      • Long Beach, California, Estados Unidos
      • Santa Maria, California, Estados Unidos
      • Thousand Oaks, California, Estados Unidos
      • Whittier, California, Estados Unidos
    • Connecticut
      • Bridgeport, Connecticut, Estados Unidos
    • Florida
      • Clearwater, Florida, Estados Unidos
      • Miami, Florida, Estados Unidos
      • Orlando, Florida, Estados Unidos
      • Sarasota, Florida, Estados Unidos
      • Tampa, Florida, Estados Unidos
    • Idaho
      • Coeur D'Alene, Idaho, Estados Unidos
    • Indiana
      • Indianapolis, Indiana, Estados Unidos
      • South Bend, Indiana, Estados Unidos
    • Minnesota
      • Eagan, Minnesota, Estados Unidos
      • Edina, Minnesota, Estados Unidos
    • Missouri
      • Saint Louis, Missouri, Estados Unidos
    • New Mexico
      • Albuquerque, New Mexico, Estados Unidos
    • New York
      • Orchard Park, New York, Estados Unidos
    • North Carolina
      • Asheville, North Carolina, Estados Unidos
      • Charlotte, North Carolina, Estados Unidos
      • Greensboro, North Carolina, Estados Unidos
      • Hickory, North Carolina, Estados Unidos
      • Wilmington, North Carolina, Estados Unidos
    • Ohio
      • Dayton, Ohio, Estados Unidos
    • Pennsylvania
      • Duncansville, Pennsylvania, Estados Unidos
      • Philadelphia, Pennsylvania, Estados Unidos
      • Pittsburgh, Pennsylvania, Estados Unidos
      • Wyomissing, Pennsylvania, Estados Unidos
    • South Carolina
      • Charleston, South Carolina, Estados Unidos
      • Columbia, South Carolina, Estados Unidos
      • Myrtle Beach, South Carolina, Estados Unidos
    • Tennessee
      • Hixson, Tennessee, Estados Unidos
      • Jakson, Tennessee, Estados Unidos
      • Nashville, Tennessee, Estados Unidos
    • Texas
      • Houston, Texas, Estados Unidos
      • Plano, Texas, Estados Unidos
      • San Antonio, Texas, Estados Unidos
    • Virginia
      • Arlington, Virginia, Estados Unidos
    • Washington
      • Spokane, Washington, Estados Unidos
    • Wisconsin
      • Glendale, Wisconsin, Estados Unidos

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 76 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Major Inclusion Criteria include (but not limited to):

  • Have a diagnosis of Rheumatoid Arthritis (according to the revised 1987 criteria of the American Rheumatism Association).
  • Treatment with infliximab and methotrexate for >= 9 months, (with stable doses of methotrexate over last 16 weeks of 7.5 mg/week to 25 mg/week) and (anti-TNFα therapy with infliximab 2 - 4 mg/kg every 4 weeks, 2 - 5 mg/kg every 5 weeks, 3 - 6 mg/kg every 6 weeks, 3 - 7mg/kg every 7 weeks, or 4 - 8 mg/kg every 8 weeks).
  • Disease Activity Score 28 (DAS28) ≥ 3.2 based on Erythrocyte Sedimentation Rate (ESR) at Week -8 and Week 0.
  • Swollen joint count (SJC) ≥ 4 and tender joint count (TJC) ≥ 4 at Week - 8 and at Week 0.
  • Prior response confirmed by physician.

Major Exclusion Criteria include (but not limited to):

  • Have a history of latent or active granulomatous infection, including histoplasmosis, or Have a history of latent or active granulomatous infection, including histoplasmosis, or coccidioidomycosis, prior to the first screening visit or during the Screening Period.
  • Have had a Bacille Calmette-Guérin (BCG) vaccination within 12 months of screening.
  • Have a chest radiograph within 3 months prior to the first administration of study agent that shows an abnormality suggestive of a malignancy or current active infection, including tuberculosis (TB), histoplasmosis, or coccidioidomycosis.
  • Have previously received more than 1 of the currently approved subcutaneous (SC) administered anti-TNFα agents, etanercept, certolizumab pegol, golimumab, or adalimumab.
  • Are pregnant, nursing, or planning a pregnancy or fathering a child within 6 months after receiving the last administration of the study agent.
  • Weight less than 35 kg or greater than 110 kg (less than 77 pounds or greater than 242 pounds).

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: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Golimumab 2 mg/kg IV
Study drug (golimumab 2 mg/kg IV) will be administered as an intravenous (IV) infusion at Weeks 0, 4, 12, 20 and 28.
Biológico: Golimumab 2 mg/kg IV
Study drug (golimumab 2 mg/kg IV) will be administered as an intravenous (IV) infusion at Weeks 0, 4, 12, 20 and 28.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Participants Who Achieved American College of Rheumatology 20 (ACR20) Response at Week 24
Periodo de tiempo: Week 24
The ACR 20 Response is defined as greater than or equal to (>=) 20 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent improvement in 3 of following 5 assessments: patient's assessment of pain using Visual Analog Scale (VAS; 0-10 millimeter [mm], 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and erythrocyte sedimentation rate (ESR).
Week 24

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Participants Who Achieved an ACR 20 Response at Week 24 With Confirmed Presence of Antibodies to Infliximab
Periodo de tiempo: Week 24
The ACR 20 Response is defined as >= 20 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (010 millimeter [mm], 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and ESR.
Week 24
Percentage of Participants Who Acheived ACR 20 Response at Week 24 With Trough Infliximab Levels Below the Lower Limit of Quantification (LLOQ)
Periodo de tiempo: Week 24
The ACR 20 Response is defined as >= 20 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (010 millimeter [mm], 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and ESR.
Week 24

Colaboradores e Investigadores

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

Patrocinador

Janssen Biotech, 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.

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 octubre de 2013

Finalización primaria (Actual)

1 de diciembre de 2014

Finalización del estudio (Actual)

1 de diciembre de 2014

Fechas de registro del estudio

Enviado por primera vez

11 de octubre de 2013

Primero enviado que cumplió con los criterios de control de calidad

11 de octubre de 2013

Publicado por primera vez (Estimar)

16 de octubre de 2013

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

12 de abril de 2017

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

1 de marzo de 2017

Última verificación

1 de marzo de 2017

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CR102117
  • CNTO148ART3003 (Otro identificador: Janssen Biotech, Inc.)
  • 2013-001809-91 (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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