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An Observational Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis And Inadequate Response Or Intolerance to a First Anti-TNF Alpha Therapy

6 de julio de 2016 actualizado por: Hoffmann-La Roche

A Non-interventional Study for Relative Efficacy Outcome of Rituximab Treatment in RA Patients Who Have Inadequate Response or Have Been Intolerant to a First Anti-TNF Agent

This prospective, multi-center, observational study will evaluate the efficacy and the safety of MabThera (rituximab) in participants with rheumatoid arthritis who have not responded or have been intolerant to a first anti-TNF alpha therapy. Participants have commenced MabThera or an alternative anti-TNF alpha treatment as a second biological therapy. Data will be collected for 12 months.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

De observación

Inscripción (Actual)

90

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

  • Corea, república de
      • Busan, Corea, república de, 48108
      • Daegu, Corea, república de, 41931
      • Daegu, Corea, república de, 42472
      • Daejeon, Corea, república de, 302-799
      • Gwangju, Corea, república de, 61469
      • Gyeonggi-do, Corea, república de, 10380
      • Jeju Special Self-Governing Province, Corea, república de, 63241
      • Jeollabuk-do, Corea, república de, 561-712
      • Seoul, Corea, república de, 150-713
      • Seoul, Corea, república de, 130-702
      • Seoul, Corea, república de, 05030
      • Seoul, Corea, república de, 06273
      • Seoul, Corea, república de, 134-722
      • Suwon, Corea, república de, 442-723
      • Ulsan, Corea, república de, 44033

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

20 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra de probabilidad

Población de estudio

Adult participants with rheumatoid arthritis who have inadequate response or have been intolerant to a first anti-TNF alpha therapy.

Descripción

Inclusion Criteria:

  • Adult participants, >/=20 years of age
  • Participants with rheumatoid arthritis, who have not responded or have been intolerant to a single anti-TNF alpha therapy and who have initiated MabThera or an alternative anti-TNF alpha therapy

Exclusion Criteria:

  • Participants whose first anti-TNF alpha treatment was, or second biological therapy is given as part of a clinical trial studying rheumatoid arthritis
  • Participants who have not signed the informed consent form

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

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Rituximab
Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician's discretion for RA treatment were observed for 12 months.
Droga: Rituximab
Rituximab as per physician's discretion.
Otros nombres:
  • Mabthera
Other anti-TNF agent
Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent, including adalimumab, etanercept and infliximab, as per physician's discretion for RA treatment were observed for 12 months.
Droga: Adalimumab
Adalimumab as per physician's discretion.
Droga: Etanercept
Etanercept as per physician's discretion.
Droga: Infliximab
Infliximab as per physician's discretion.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Efficacy: Mean Change From Baseline in DAS28 at Month 6 in Intention to Treat (ITT) Population
Periodo de tiempo: Baseline and Month 6
DAS28 is calculated from the number of swollen joints and tender joints using the 28-joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and patient's global assessment of disease activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 (minimum score) to 10 (maximum score); higher scores indicated greater affectation due to disease activity. A DAS28 score of less than or equal to (=<) 3.2 = low disease activity, a DAS28 score of >3.2 to 5.1 = moderate to high disease activity.
Baseline and Month 6
Efficacy: Mean Change From Baseline in DAS28 at Month 6 in Standard Population Set (SPS)
Periodo de tiempo: Baseline and Month 6
DAS28 is calculated from the number of swollen joints and tender joints using the 28-joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 (minimum score) to 10 (maximum score); higher scores indicated greater affectation due to disease activity. A DAS28 score of less than or equal to (=<) 3.2 = low disease activity, a DAS28 score of >3.2 to 5.1 = moderate to high disease activity.
Baseline and Month 6

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Efficacy: Mean Change From Baseline in DAS28 at Month 12
Periodo de tiempo: Baseline and Month 12
DAS28 is calculated from the number of swollen joints and tender joints using the 28-joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 (minimum score) to 10 (maximum score); higher scores indicated greater affectation due to disease activity. A DAS28 score of less than or equal to (=<) 3.2 = low disease activity, a DAS28 score of >3.2 to 5.1 = moderate to high disease activity.
Baseline and Month 12
Efficacy: Mean Change From Baseline in Tender Joint Count (TJC) at Month 6 and 12 in Intention to Treat (ITT) Population
Periodo de tiempo: Baseline, Month 6 and 12
TJC is a clinical method to quantify abnormalities in participants with RA. It is associated with the level of pain. The number of tender joints were scored as tender=1 and not tender=0, and counted. A negative change from baseline represents an improvement (a reduction in the number of tender joints).
Baseline, Month 6 and 12
Efficacy: Mean Change From Baseline in Tender Joint Count (TJC) at Month 6 and 12 in Standard Population Set (SPS)
Periodo de tiempo: Baseline, Month 6 and 12
TJC is a clinical method to quantify abnormalities in participants with RA. It is associated with the level of pain. The number of tender joints were scored as tender=1 and not tender=0, and counted. A negative change from baseline represents an improvement (a reduction in the number of tender joints).
Baseline, Month 6 and 12
Efficacy: Mean Change From Baseline in Swollen Joint Count (SJC) at Month 6 and 12 in Intention to Treat (ITT) Population
Periodo de tiempo: Baseline, Month 6 and 12
SJC is a clinical method to quantify abnormalities in participants with RA. It reflects the amount of inflamed synovial tissue. The number of swollen joints were scored as swollen=1 and not swollen=0, and counted. A negative change from baseline represents an improvement (a reduction in the number of swollen joints).
Baseline, Month 6 and 12
Efficacy: Mean Change From Baseline in Swollen Joint Count (SJC) at Month 6 and 12 in Standard Population Set (SPS)
Periodo de tiempo: Baseline, Month 6 and 12
SJC is a clinical method to quantify abnormalities in participants with RA. It reflects the amount of inflamed synovial tissue. The number of swollen joints were scored as swollen=1 and not swollen=0, and counted. A negative change from baseline represents an improvement (a reduction in the number of swollen joints).
Baseline, Month 6 and 12
Efficacy: Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12 in Intention to Treat (ITT) Population
Periodo de tiempo: Baseline, Month 6 and 12
ESR is an acute phase reactant and a measure of inflammation. A negative change from baseline represents a reduction in inflammation.
Baseline, Month 6 and 12
Efficacy: Mean Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 6 and 12 in Standard Population Set (SPS)
Periodo de tiempo: Baseline, Month 6 and 12
ESR is an acute phase reactant and a measure of inflammation. A negative change from baseline represents a reduction in inflammation.
Baseline, Month 6 and 12
Efficacy: Mean Change From Baseline in C-reactive Protein (CRP) at Month 6 and 12 in Intention to Treat (ITT) Population
Periodo de tiempo: Baseline, Month 6 and 12
CRP is an inflammation marker. High levels of this protein indicate inflammation in diseases such as RA. A negative change from baseline represents a reduction in inflammation.
Baseline, Month 6 and 12
Efficacy: Mean Change From Baseline in C-reactive Protein (CRP) at Month 6 and 12 in Standard Population Set (SPS)
Periodo de tiempo: Baseline, Month 6 and 12
CRP is an inflammation marker. High levels of this protein indicate inflammation in diseases such as RA. A negative change from baseline represents a reduction in inflammation.
Baseline, Month 6 and 12
Efficacy: Health Assessment Questionnaire-Disability Index (HAQ-DI) in Intention to Treat (ITT) Population
Periodo de tiempo: Month 6
The HAQ-DI is a participant-completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0 (without any difficulty) to 3 (unable to do). The overall HAQ-DI score is the average of each of the 8 category scores and ranges from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability.
Month 6
Efficacy: Health Assessment Questionnaire-Disability Index (HAQ-DI) in Standard Population Set (SPS)
Periodo de tiempo: Month 6
The HAQ-DI is a participant-completed questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. Each domain has at least two component questions. There are four possible responses for each component ranging from 0 (without any difficulty) to 3 (unable to do). The overall HAQ-DI score is the average of each of the 8 category scores and ranges from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability.
Month 6
Safety: Number of Participants With Adverse Events (AE), Adverse Drug Reactions (ADR) and Serious Adverse Events
Periodo de tiempo: Baseline up to Month 12
An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. ADRs were defined as any response to a drug which was noxious and unintended, and which occurred at dose normally used related to the pharmacological properties. A SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant.
Baseline up to Month 12

Colaboradores e Investigadores

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

Patrocinador

Hoffmann-La Roche

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 2011

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 abril de 2012

Primero enviado que cumplió con los criterios de control de calidad

3 de mayo de 2012

Publicado por primera vez (Estimar)

7 de mayo de 2012

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

22 de agosto de 2016

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

6 de julio de 2016

Última verificación

1 de marzo de 2016

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • ML27923

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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