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Atacicept in Combination With Rituximab in Subjects With Rheumatoid Arthritis (August III) (August III)

4 de noviembre de 2016 actualizado por: Merck KGaA, Darmstadt, Germany

A Randomized, Double-blind, Placebo Controlled, Multi-centre, Exploratory, Pilot, Phase II Trial of 150mg Atacicept Given Subcutaneously in Combination With Rituximab in Subjects With Rheumatoid Arthritis.

The primary objective of this study is to assess the safety and tolerability of combined treatment with atacicept and rituximab in subjects with active rheumatoid arthritis (RA) receiving re-treatment with rituximab.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

27

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

  • Francia
      • Nice, Francia
        • Research Site
      • Paris, Francia
        • Research Site
      • Strasbourg, Francia
        • Research Site
  • Países Bajos
      • Amsterdam, Países Bajos
        • Research Site
  • Reino Unido
      • Newcastle, Reino Unido
        • Research Site
      • Norwich, Reino Unido
        • Research Site
  • Suecia
      • Malmö, Suecia
        • Research Site
      • Stockholm, Suecia
        • Research Site

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:

  • Male and female subjects
  • Greater than and equal to (>=) 18 years of age at the time of Informed Consent
  • Who have rheumatoid arthritis satisfying American College of Rheumatology (ACR) criteria with a disease history of at least 12 months
  • Subjects must have active disease defined by DAS28 >3.2
  • Subjects must have received previous treatment with rituximab and must be candidates for re-treatment with rituximab
  • Female subjects of childbearing potential must be willing to avoid pregnancy by using an adequate method of contraception for 4 weeks before study day 1 (SD1), during the treatment period and for 12 months after the last dose of rituximab, and must have a negative urine pregnancy test at the screening visit and SD1
  • Other protocol defined inclusion criteria could apply

Exclusion Criteria:

  • Current neurological disease excluding migraine
  • Inflammatory joint disease other than rheumatoid arthritis
  • Any contraindication to rituximab as per national label
  • Use of disease-modifying anti-rheumatic drugs (DMARDs; including methotrexate) for less than 3 months or change in dosing regimen within 28 days before SD1, or methotrexate dose regimen >25 mg/week
  • Participation in any interventional clinical trial within 1 month before SD1 (or within 5 half-lives of the investigated compound before SD1, whichever is longer)
  • Prednisone dose regimen >10 mg/day (or equivalent), or change in steroid dosing regimen within 28 days before SD1
  • Active or latent tuberculosis within the year before screening or major infection requiring hospitalization or intravenous anti-infectives within 28 days before SD1
  • Serum Immunoglobulin G (IgG) below 6 gram per liter (g/L)
  • Known hypersensitivity to atacicept or to any of the components of the formulated atacicpet
  • Known hypersensitivity to rituximab, to any of the components of the formulated rituximab or to murine proteins
  • Breastfeeding or pregnancy
  • Other protocol defined exclusion criteria could apply

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: Rituximab Plus Atacicept
Rituximab will be administered as an intravenous infusion at a dose of 1000 mg at Weeks 1 and 3, followed by atacicept 150 mg subcutaneously once a week from Week 7 to 32.
Biológico: Rituximab
Rituximab will be administered as an intravenous infusion at a dose of 1000 mg at Weeks 1 and 3.
Droga: Atacicept
Atacicept will be administered at a dose of 150 mg subcutaneously once a week from Week 7 to 32.
Comparador de placebos: Rituximab Plus Placebo
Rituximab will be administered as an intravenous infusion at a dose of 1000 mg at Weeks 1 and 3, followed by placebo matched to atacicept subcutaneously once a week from Week 7 to 32.
Biológico: Rituximab
Rituximab will be administered as an intravenous infusion at a dose of 1000 mg at Weeks 1 and 3.
Droga: Placebo matched to atacicept
Placebo matched to atacicept will be administered subcutaneously once a week from Week 7 to 32.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Periodo de tiempo: Baseline up to Week 64
An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. An SAE was defined as an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
Baseline up to Week 64
Percentage of Participants With Immunoglobulin G (IgG) Level Less Than 3 Gram Per Liter (g/L)
Periodo de tiempo: Week 64
Week 64
Percent Change From Baseline in Vital Signs and Routine Safety Lab Parameters at Week 32
Periodo de tiempo: Baseline, Week 32
Vital signs assessed included blood pressure (systolic and diastolic), pulse and body temperature. Routine safety lab parameters evaluated included red blood cell (RBC), hemoglobin, hematocrit, platelets, mean cellular hemoglobin (MCH), MCH concentration, MCH volume, white blood cell (WBC), lymphocytes, monocytes, eosinophils, basophils, neutrophils, gamma glutamyl transferase (GGT), alanine aminotransferase (ALT), albumin, alkaline phosphatase (AP), aspartate aminotransferase (AST), bilirubin, calcium, creatinine, glucose, potassium, total protein, sodium, uric acid, and blood urea nitrogen. Percent change from baseline was calculated as ([Week 32 value minus baseline value] multiplied by 100) divided by baseline value.
Baseline, Week 32
Percent Change From Baseline in Anti-tetanus and Anti-diphteria Immunization Titer at Week 32
Periodo de tiempo: Baseline, Week 32
Percent change from baseline was calculated as ([Week 32 value minus baseline value] multiplied by 100) divided by baseline value.
Baseline, Week 32
Percent Change From Baseline in Anti-pneumococcus Titer at Week 32
Periodo de tiempo: Baseline, Week 32
Percent change from baseline was calculated as ([Week 32 value minus baseline value] multiplied by 100) divided by baseline value.
Baseline, Week 32

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Participants Achieving American College of Rheumatology 20 Response Based on C-reactive Protein (ACR20-CRP), ACR50-CRP and ACR70-CRP at Week 32
Periodo de tiempo: Week 32
ACR20-CRP response: greater than or equal to (>=) 20 percent (%) improvement in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) together with >=20% improvement in at least 3 of the following: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function; and 5) acute-phase marker (CRP). ACR50-CRP and ACR70-CRP response are defined as >=50% and >=70% improvement in both tender joint counts (based on a total of 68 joints) and swollen joint counts (based on a total of 66 joints) respectively together with >=50% and >=70% improvement in at least 3 of the following respectively: 1) participant's assessment of pain; 2) participant's global assessment of disease activity; 3) physician's global assessment of disease activity; 4) participant's assessment of physical function; and 5) CRP.
Week 32
Change From Baseline in Disease Activity Score in 28 Joints (DAS28) Based on CRP (DAS28-CRP) at Week 32
Periodo de tiempo: Baseline, Week 32
DAS28-CRP incorporates non-graded joint counts for tenderness and swelling based on a total of 28 joints, CRP as a marker of inflammation, and a general health assessment using a 100 mm visual analog scale (the participant's global assessment of disease activity). DAS28 score ranges between 0 and 10 representing current disease activity. A value above 5.1 represents high disease activity, a value below 3.2 represents low disease activity, and a value below 2.6 represents remission.
Baseline, Week 32
Median Percentage Change From Baseline in Levels of Total, Mature and Memory B Cells
Periodo de tiempo: Baseline, Week 3, 7, 12, 16, 26 and 32
Flow cytometric analysis of lymphocyte populations using four-color fluorescence-activated cell sorting was performed for the analysis of total, mature and memory B cell levels.
Baseline, Week 3, 7, 12, 16, 26 and 32

Colaboradores e Investigadores

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

Patrocinador

Merck KGaA, Darmstadt, Germany

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 marzo de 2008

Finalización primaria (Actual)

1 de octubre de 2010

Finalización del estudio (Actual)

1 de octubre de 2010

Fechas de registro del estudio

Enviado por primera vez

21 de abril de 2008

Primero enviado que cumplió con los criterios de control de calidad

22 de abril de 2008

Publicado por primera vez (Estimar)

23 de abril de 2008

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

30 de diciembre de 2016

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

4 de noviembre de 2016

Última verificación

1 de noviembre de 2016

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 28155

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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