A Feasibility Study Exploring the Effect of Remicade on the Disease Activity in RA Patients (Study P05417) (REQUEST)
2 de enero de 2017 actualizado por: Merck Sharp & Dohme LLC
A Feasibility Study Exploring the Effect of Remicade on the Disease Activity in RA Patients
This observational study will explore the Swedish national population of patients with rheumatoid arthritis (RA) on infliximab maintenance therapy in order to identify patients who may be eligible for a dose reduction study.
Patients will be asked a variety of questions regarding their treatment dosing and disease activity, and then asked whether or not they would consider participating in a dose reduction study.
Patients in this study will be described in terms of demographic and disease characteristics.
Descripción general del estudio
Descripción detallada
Already known Subjects (RA and on at least 12 months ongoing Remicade treatment) from the clinic could participate if they are eligible.
Tipo de estudio
De observación
Inscripción (Actual)
363
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
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
Subjects are Swedish patients on maintenance therapy for RA with infliximab for >= the past 12 months.
Descripción
Inclusion Criteria:
- Rheumatoid arthritis, infliximab maintenance treatment for at least the past 12 months, given written informed consent.
Exclusion Criteria:
- episodic treatment with infliximab
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
- Modelos observacionales: Grupo
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
RA patients
Patients on maintenance therapy for RA with infliximab for >= the past 12 months.
|
Treatment of RA with Infliximab according to and under normal routine clinical practice.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Dosing Interval Between the Infliximab Infusions
Periodo de tiempo: Measured from the Remicade Questionnaire at first (and only) study visit
|
Patients were asked as part of the Remicade questionnaire what dosing interval they were on.
|
Measured from the Remicade Questionnaire at first (and only) study visit
|
|
Reason for Extending Dosing Interval
Periodo de tiempo: Measured from the Remicade Questionnaire at first (and only) study visit
|
Among patients who reported that they at some occasion during treatment with infliximab had a longer dosing interval than every 8 weeks, the reason for extending dosing interval was asked of each patient.
|
Measured from the Remicade Questionnaire at first (and only) study visit
|
|
Patient Response to Increased Dosing Interval
Periodo de tiempo: Measured from the Remicade Questionnaire at first (and only) study visit
|
Among patients who reported that they at some occasion during treatment with infliximab had a longer dosing interval than every 8 weeks, patients were asked "did you notice any difference when your dosing interval was extended?"
Those who noticed a difference were asked if their experience was positive or negative.
|
Measured from the Remicade Questionnaire at first (and only) study visit
|
|
Number of Patients Agreeing to Participate in a Dose Reduction Study
Periodo de tiempo: Measured from the Remicade Questionnaire at first (and only) study visit
|
As part of the Remicade questionnaire, patients were asked "would you consider participating in a dose reduction study?"
|
Measured from the Remicade Questionnaire at first (and only) study visit
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Disease Activity Score Based on Assessment of 28 Joints (DAS28), Health Assessment Questionnaire (HAQ), C-reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), Infliximab Dosage.
Periodo de tiempo: Measured at first (and only) study visit, and outcomes measured during the two preceding physician visits are extracted from the Swedish Rheumatoid Arthritis (RA) Registry.
|
This is not a prespecified key secondary outcome; therefore, results will not be disclosed
|
Measured at first (and only) study visit, and outcomes measured during the two preceding physician visits are extracted from the Swedish Rheumatoid Arthritis (RA) Registry.
|
|
Adverse Events (AEs)
Periodo de tiempo: Collected at first (and only) study visit, all AEs reported during the previous 12 months is collected from the Swedish Rheumatoid Arthritis (RA) Registry.
|
This is not a prespecified key secondary outcome; therefore, results will not be disclosed
|
Collected at first (and only) study visit, all AEs reported during the previous 12 months is collected from the Swedish Rheumatoid Arthritis (RA) Registry.
|
|
Duration of Subject's Rheumatoid Arthritis (RA) Diagnosis, European Quality of Life Group 1990 5 Dimension (EQ5D) and Patient Remicade Questionnaire.
Periodo de tiempo: Measured at first (and only) study visit, and outcomes measured during the two preceding physician visits are extracted from the Swedish Rheumatoid Arthritis (RA) Registry.
|
This is not a prespecified key secondary outcome; therefore, results will not be disclosed
|
Measured at first (and only) study visit, and outcomes measured during the two preceding physician visits are extracted from the Swedish Rheumatoid Arthritis (RA) Registry.
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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.
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 enero de 2008
Finalización primaria (Actual)
1 de junio de 2008
Finalización del estudio (Actual)
1 de junio de 2008
Fechas de registro del estudio
Enviado por primera vez
30 de julio de 2008
Primero enviado que cumplió con los criterios de control de calidad
22 de agosto de 2008
Publicado por primera vez (Estimar)
26 de agosto de 2008
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
4 de enero de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
2 de enero de 2017
Última verificación
1 de enero de 2017
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- P05417
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. .