Health-related Quality of Life and Patient-reported Outcomes in Rheumatoid Arthritis Patients Treated With Certolizumab Pegol (SONAR-12)
18 de marzo de 2014 actualizado por: UCB Pharma SA
An Open-label, Observational 12-week Study to Assess Health-related Quality of Life and Patient-reported Outcomes in Patients With Rheumatoid Arthritis Treated With Certolizumab Pegol
The main objective is to assess Health-Related Quality of Life (HRQoL) according to physical function, as measured by a specific Questionnaire (Health Assessment Questionnaire), in Rheumatoid Arthritis (RA) patients who begin therapy with subcutaneous Anti-Tumour Necrosis Factor alpha (TNFα) Certolizumab Pegol (CZP).
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
An open-label, prospective, and post-authorization observational study.
This non-interventional study is designed to establish the importance of the measurement of HRQoL data and patient-reported outcomes in clinical practice in patients with RA, and to assess efficacy and safety use of CZP according to the summary of product characteristics.
Tipo de estudio
De observación
Inscripción (Actual)
81
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
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A Coruña, España
- 11
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Barcelona, España
- 7
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Barcelona, España
- 15
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Barcelona, España
- 20
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Barcelona, España
- 4
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Girona, España
- 21
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Granada, España
- 9
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Leon, España
- 12
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Lerida, España
- 18
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Lérida, España
- 17
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Salamanca, España
- 6
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Sevilla, España
- 10
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Tarragona, España
- 14
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Tarragona, España
- 16
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Vigo, España
- 5
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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
Método de muestreo
Muestra de probabilidad
Población de estudio
Patients with RA who begin therapy with CZP will be consecutively included in accordance with the selection criteria. The choice of medical treatment is made independently by the physician before evaluating the possible participation of the patient in the study protocol.
The study will include approximately 105 patients from 20 to 25 sites in Spain.
Descripción
Inclusion Criteria:
- Patient is male or female, aged 18 years or older
- Patient has active Rheumatoid Arthritis according to American College of Rheumatology (ACR) criteria with duration ≥ 3 months
- Patient has DAS28 (ESR) > 4.5 and CRP > 1.0 mg/dl at Baseline
- Patient has failed previous Disease Modifying Anti-Rheumatic Drugs (DMARDs) including Methotrexate treatment
- Patient has initiated treatment with subcutaneous anti-Tumour Necrosis Factor alpha (anti-TNFα) CZP, administered every 2 weeks
- Patient has no other prior anti-TNFα treatment (Naïve Patient) or CZP is administered after failure to the first anti-TNFα treatment (First Switch Patient)
- Patient is considered reliable and capable of adhering to the protocol, visit schedule or medication intake according to the judgment of the physician
- Patient has signed and dated a written informed consent form
- The patient's treatment must be within the terms of Summary of Product Characteristics (SmPC)
Exclusion Criteria:
- Patient has a known hypersensitivity to the active substance or to any of the excipients
- Patient has active Tuberculosis or other severe infections such as Sepsis or Opportunistic Infections
- Patient has moderate to severe Heart Failure (New York Heart Association (NHYA) classes III/IV)
- Patient has any medical or psychiatric condition that, in the opinion of the physician, could jeopardize or would compromise the patient's ability to participate in this study or to complete the scheduled questionnaires
- Pregnant women or women of childbearing potential who are not using adequate contraception to prevent pregnancy
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 |
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Certolizumab Pegol treatment
Patients with RA who begin therapy with Certolizumab Pegol (CZP) will be consecutively included in accordance with the selection criteria.
The choice of medical treatment is made independently by the physician before evaluating the possible participation of the patient in the protocol.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change from Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12
Periodo de tiempo: From Baseline (Week 0) to Week 12
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The HAQ-DI is a measure of function in Rheumatoid Arthritis.
There are 20 items in eight categories that represent a comprehensive set of functional activities on a scale from 0 (without difficulty) to 3 (unable to perform without assistance).
The category scores are averaged into an overall HAQ-DI from 0 to 3. Scores of 0 to 1 generally represent mild to moderate difficulty, 1 to 2 represent moderate to severe disability, and 2 to 3 indicate severe to very severe disability.
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From Baseline (Week 0) to Week 12
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Number of Adverse Drug Reactions (ADRs) during the study (up to 16 weeks)
Periodo de tiempo: From Baseline (Week 0) to the end of the Follow-up Period (Week 16)
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An ADR is an Adverse Event for which a causal relationship between the product and the occurrence is suspected.
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From Baseline (Week 0) to the end of the Follow-up Period (Week 16)
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Number of Serious Adverse Drug Reactions (SADRs) during the study (up to 16 weeks)
Periodo de tiempo: From Baseline (Week 0) to the end of the Follow-up Period (Week 16)
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A SADR is a serious Adverse Event for which a causal relationship between the product and the occurrence is suspected.
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From Baseline (Week 0) to the end of the Follow-up Period (Week 16)
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Number of subjects with at least one Adverse Drug Reaction (ADR) during the study (up to 16 weeks)
Periodo de tiempo: From Baseline (Week 0) to the end of the Follow-up Period (Week 16)
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An ADR is an Adverse Event for which a causal relationship between the product and the occurrence is suspected.
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From Baseline (Week 0) to the end of the Follow-up Period (Week 16)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change from Baseline in the Short Form-36 (SF-36) Item Questionnaire Physical Component Summary (PCS) at Week 12
Periodo de tiempo: From Baseline (Week 0) to Week 12
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The SF-36 measures the Health Related Quality of Life (HRQoL).
It is a 36-item survey that measures eight domains of health.
Four of these domains belong to physical health and four domains to mental health.
Domain scores are generated from the SF-36.
In addition, two summary scores can also be derived from the SF-36: The Physical Component Summary (PCS) and the Mental Component Summary (MCS).
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From Baseline (Week 0) to Week 12
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Change from Baseline in the Short Form-36 (SF-36) Item Questionnaire Mental Component Summary (MCS) at Week 12
Periodo de tiempo: From Baseline (Week 0) to Week 12
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The SF-36 measures the Health Related Quality of Life (HRQoL).
It is a 36-item survey that measures eight domains of health.
Four of these domains belong to physical health and four domains to mental health.
Domain scores are generated from the SF-36.
In addition, two summary scores can also be derived from the SF-36: The Physical Component Summary (PCS) and the Mental Component Summary (MCS).
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From Baseline (Week 0) to Week 12
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Change from Baseline in Patient's Assessment of Arthritis Pain- Visual Analog Scale (VAS) at Week 12
Periodo de tiempo: From Baseline (Week 0) to Week 12
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VAS ranges from 0 (no pain) to 100 (worst pain).
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From Baseline (Week 0) to Week 12
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Change from Baseline in Disease Activity Score 28 [Erythrocyte Sedimentation Rate] (DAS28 [ESR]) at Week 12
Periodo de tiempo: From Baseline (Week 0) to Week 12
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The DAS28 is used for assessing disease activity in RA.
The number of swollen and tender joints will be assessed using 28-joint counts (tender 28 and swollen 28).
The ESR is measured in mm/h.
In addition the Patient's General Health (GH) is obtained and recorded on a Visual Analog Scale (VAS) of 100 mm.
Using this data, the DAS28 [ESR] can be calculated.
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From Baseline (Week 0) to Week 12
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Change from Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 12
Periodo de tiempo: From Baseline (Week 0) to Week 12
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ESR is an inflammatory parameter measured in mm/h.
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From Baseline (Week 0) to Week 12
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Change from Baseline in the Rheumatoid Factor (RF) at Week 12
Periodo de tiempo: From Baseline (Week 0) to Week 12
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RF is an inflammatory parameter measured in International Units (IU)/ml.
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From Baseline (Week 0) to Week 12
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Change from Baseline in Serum C-reactive Protein (CRP) level at Week 12
Periodo de tiempo: From Baseline (Week 0) to Week 12
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CRP is an inflammatory parameter measured in mg/l.
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From Baseline (Week 0) to Week 12
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Change from Baseline in the C3 level at Week 12
Periodo de tiempo: From Baseline (Week 0) to Week 12
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C3 is an inflammatory parameter.
This measurement includes only subjects for which C3 data are available in the medical history of the subject.
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From Baseline (Week 0) to Week 12
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Change from Baseline in the C4 level at Week 12
Periodo de tiempo: From Baseline (Week 0) to Week 12
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C4 is an inflammatory parameter.
This measurement includes only subjects for which C4 data are available in the medical history of the subject.
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From Baseline (Week 0) to Week 12
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Predictive value of Baseline global ultrasound index in relation to DAS28 at Week 12
Periodo de tiempo: From Baseline (Week 0) to Week 12
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From Baseline (Week 0) to Week 12
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Predictive value of Week 6 global ultrasound index in relation to DAS28 at Week 12
Periodo de tiempo: From Week 6 to Week 12
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From Week 6 to Week 12
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Predictive value of Baseline laboratory data ESR in relation to DAS28 at Week 12
Periodo de tiempo: From Baseline (Week 0) to Week 12
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From Baseline (Week 0) to Week 12
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Predictive value of Week 6 laboratory data ESR in relation to DAS28 at Week 12
Periodo de tiempo: From Week 6 to Week 12
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From Week 6 to Week 12
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Predictive value of Baseline laboratory data CRP in relation to DAS28 at Week 12
Periodo de tiempo: From Baseline (Week 0) to Week 12
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From Baseline (Week 0) to Week 12
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Predictive value of Week 6 laboratory data CRP in relation to DAS28 at Week 12
Periodo de tiempo: From Week 6 to Week 12
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From Week 6 to Week 12
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Predictive value of Baseline laboratory data RF in relation to DAS28 at Week 12
Periodo de tiempo: From Baseline (Week 0) to Week 12
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From Baseline (Week 0) to Week 12
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Predictive value of Week 6 laboratory data RF in relation to DAS28 at Week 12
Periodo de tiempo: From Week 6 to Week 12
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From Week 6 to Week 12
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Predictive value of Baseline Reduced models of ultrasound joint count in relation to DAS28 at Week 12
Periodo de tiempo: From Baseline (Week 0) to Week 12
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From Baseline (Week 0) to Week 12
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Predictive value of Week 6 Reduced models of ultrasound joint count in relation to DAS28 at Week 12
Periodo de tiempo: From Week 6 to Week 12
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From Week 6 to Week 12
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Predictive value of Baseline Reduced models of ultrasound index in relation to DAS28 at Week 12
Periodo de tiempo: From Baseline (Week 0) to Week 12
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From Baseline (Week 0) to Week 12
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Predictive value of Week 6 Reduced models of ultrasound index in relation to DAS28 at Week 12
Periodo de tiempo: From Week 6 to Week 12
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From Week 6 to Week 12
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Change from Baseline in global ultrasound index at Week 6
Periodo de tiempo: From Baseline (Week 0) to Week 6
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Ultrasound assessment by global ultrasound index consists of 24-joint detection and grading (from 0 to 3) of gray-scale synovitis and power doppler synovial signal.
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From Baseline (Week 0) to Week 6
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Change from Baseline in global ultrasound index at Week 12
Periodo de tiempo: From Baseline (Week 0) to Week 12
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Ultrasound assessment by global ultrasound index consists of 24-joint detection and grading (from 0 to 3) of gray-scale synovitis and power doppler synovial signal.
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From Baseline (Week 0) to Week 12
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Number of injection site reactions during the study (up to 16 weeks)
Periodo de tiempo: From Baseline (Week 0) to the end of the Follow-up Period (Week 16)
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Injection site reactions include: erythema, itching, haematoma, pain, swelling or bruising.
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From Baseline (Week 0) to the end of the Follow-up Period (Week 16)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
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 2012
Finalización primaria (Actual)
1 de marzo de 2014
Finalización del estudio (Actual)
1 de marzo de 2014
Fechas de registro del estudio
Enviado por primera vez
1 de febrero de 2012
Primero enviado que cumplió con los criterios de control de calidad
1 de febrero de 2012
Publicado por primera vez (Estimar)
3 de febrero de 2012
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
19 de marzo de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
18 de marzo de 2014
Última verificación
1 de marzo de 2014
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- RA0053
- UCB-CER-2010-01
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. .