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- Ensayo clínico NCT01521884
Study Looking at Longitudinal Changes in Fatigue and Health Status in Rheumatoid Arthritis (RA) Patients Treated With Subcutaneous Anti-TNF-α Therapy
3 de febrero de 2015 actualizado por: Pfizer
Longitudinal Changes In Fatigue And Health Status (aims2) In Ra Patients Treated With Sc Anti-tnf-alpha Therapy
People affected by rheumatoid arthritis are often suffering from fatigue and decreased QOL.
In this study we are measuring the impact of SC biologics on these parameters.
Descripción general del estudio
Descripción detallada
Observational prospective study Purely descriptive
Tipo de estudio
De observación
Inscripción (Actual)
62
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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Leuven, Bélgica, 3000
- Uz Gasthuisberg
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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 seen in a rheumatology practice
Descripción
Inclusion Criteria:
Patients who:
- Are active RA patients (as judged by treating MD)
- Are 18 years of age or older at time of consent
- Are scheduled by their rheumatologist to initiate SC anti-TNF-α therapy + MTX
Exclusion Criteria:
Use of biologics (or any experimental drug) in the last 3 months before initiation of SC anti-TNF-α therapy.
Participation in other clinical or observational trials
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 |
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RA Patients treated with SC anti-TNF
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SC anti-TNF
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Baseline
Periodo de tiempo: Baseline
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AIMS2 is a disease-specific measure of physical, social, and emotional well-being.
It is a 78-item questionnaire assessing 12 scales: moving capacities, walking and dexterity, hand and fingers movements, arm movements, self-care, household activities, social activities, support of family and friends, joint pain, work, nervous tension and psychological condition (anxiety and depression).
Each item was scored as 0 (or 1, best situation) to 4 (worst situation).
Sub-total score of each of the 12 scales normalized to a maximum of 10.
Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain) with total score range from 0 to 10 for all component scores, where higher scores indicated worse situation.
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Baseline
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Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 6
Periodo de tiempo: Month 6
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AIMS2 is a disease-specific measure of physical, social, and emotional well-being.
It is a 78-item questionnaire assessing 12 scales: moving capacities, walking and dexterity, hand and fingers movements, arm movements, self-care, household activities, social activities, support of family and friends, joint pain, work, nervous tension and psychological condition (anxiety and depression).
Each item was scored as 0 (or 1, best situation) to 4 (worst situation).
Sub-total score of each of the 12 scales normalized to a maximum of 10.
Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain) with total score range from 0 to 10 for all component scores, where higher scores indicated worse situation.
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Month 6
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Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 12
Periodo de tiempo: Month 12
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AIMS2 is a disease-specific measure of physical, social, and emotional well-being.
It is a 78-item questionnaire assessing 12 scales: moving capacities, walking and dexterity, hand and fingers movements, arm movements, self-care, household activities, social activities, support of family and friends, joint pain, work, nervous tension and psychological condition (anxiety and depression).
Each item was scored as 0 (or 1, best situation) to 4 (worst situation).
Sub-total score of each of the 12 scales normalized to a maximum of 10.
Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain) with total score range from 0 to 10 for all component scores, where higher scores indicated worse situation.
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Month 12
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Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 18
Periodo de tiempo: Month 18
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AIMS2 is a disease-specific measure of physical, social, and emotional well-being.
It is a 78-item questionnaire assessing 12 scales: moving capacities, walking and dexterity, hand and fingers movements, arm movements, self-care, household activities, social activities, support of family and friends, joint pain, work, nervous tension and psychological condition (anxiety and depression).
Each item was scored as 0 (or 1, best situation) to 4 (worst situation).
Sub-total score of each of the 12 scales normalized to a maximum of 10.
Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain) with total score range from 0 to 10 for all component scores, where higher scores indicated worse situation.
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Month 18
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Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 24
Periodo de tiempo: Month 24
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AIMS2 is a disease-specific measure of physical, social, and emotional well-being.
It is a 78-item questionnaire assessing 12 scales: moving capacities, walking and dexterity, hand and fingers movements, arm movements, self-care, household activities, social activities, support of family and friends, joint pain, work, nervous tension and psychological condition (anxiety and depression).
Each item was scored as 0 (or 1, best situation) to 4 (worst situation).
Sub-total score of each of the 12 scales normalized to a maximum of 10.
Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain) with total score range from 0 to 10 for all component scores, where higher scores indicated worse situation.
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Month 24
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Visual Analog Scale (VAS) Fatigue Score
Periodo de tiempo: Baseline, Month 6, 12, 18, 24
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Participants recorded their fatigue score on a range of 0 to 10, where higher score indicated higher intensity of fatigue.
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Baseline, Month 6, 12, 18, 24
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Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (DAS 28-ESR)
Periodo de tiempo: Baseline, Month 6, 12, 18, 24
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DAS28-ESR was calculated from the number of swollen joints (SJC) and tender joints (TJC ) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeter per hour [mm/hour]) and participant's assessment of disease activity visual analog scale (scores ranging 0 [very well] to 100 mm [extremely bad]).
Total score range: 0-10, higher score=more disease activity (DA).
DAS28-ESR less than equal to (<=) 3.2 = low disease activity, DAS28 greater than (>) 3.2 to 5.1 = moderate to high DA
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Baseline, Month 6, 12, 18, 24
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Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (DAS 28-CRP)
Periodo de tiempo: Baseline, Month 6, 12, 18, 24
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DAS28-CRP was calculated from the number of swollen joints ( SJC) and tender joints (TJC) count using 28 joint count and CRP (milligram per liter [mg/L]).
Total score range: 0-10, higher score= more disease activity.
DAS28 (CRP) : <3.2= low disease activity, >3.2 to 5.1 = moderate to high disease activity and less than (<)2.6 = remission.
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Baseline, Month 6, 12, 18, 24
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Health Assessment Questionnaire (HAQ) Total Score
Periodo de tiempo: Baseline, Month 6, 12, 18, 24
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HAQ: 20-item participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom, arise, eat, walk, reach, grip, hygiene and common activities.
Each item scored on 4-point scale, 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do.
Overall score was computed as sum of item scores.
HAQ total score was 0 to 60 (as used in Belgium), where greater score indicated greater difficulty.
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Baseline, Month 6, 12, 18, 24
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Spearman Correlation Coefficient Between Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Components and Visual Analog Scale (VAS) Fatigue Score
Periodo de tiempo: Baseline, Month 6, 12, 18, 24
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Spearman correlation coefficient between AIMS2 component score and VAS fatigue score (AIMS2 component score versus [vs] VAS fatigue) was calculated.
AIMS2 : 78-item questionnaire assessing 12 scales.
Each item was scored as 0 (or 1, best situation) to 4 (worst situation).
Sub-total score of each of the 12 scales normalized to a maximum of 10.
Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain); total score range from 0 to 10, higher scores indicates worse situation and VAS score: Participants recorded their fatigue score on a range of 0 to 10, where higher score indicated higher intensity of fatigue.
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Baseline, Month 6, 12, 18, 24
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Pearson Correlation Coefficient Between Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Components and Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation (DAS 28-ESR)
Periodo de tiempo: Baseline, Month 6,1 2, 18, 24
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Pearson correlation coefficient between AIMS2 component score and DAS28-ESR score (AIMS2 component score vs DAS28-ESR) was calculated.
AIMS2: 78-item questionnaire assessing 12 scales.
Each item was scored as 0 (or 1, best situation) to 4 (worst situation).
Sub-total score of each of the 12 scales normalized to a maximum of 10.
Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain); total score range from 0 to 10, higher scores indicates worse situation and DAS28-ESR calculated from the number of SJC and TJC using the 28 joints count, ESR (mm/hour) and participant's assessment of disease activity VAS (scores ranging 0 [very well] to 100 mm [extremely bad]).
Total score range: 0-10, higher score= more disease activity.
DAS28-ESR <= 3.2 = low DA, DAS28 > 3.2 to 5.1 = moderate to high DA.
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Baseline, Month 6,1 2, 18, 24
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Pearson Correlation Coefficient Between Arthritis Impact Measurement Scale- Version 2 (AIMS2) Main Components and Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (DAS 28-CRP)
Periodo de tiempo: Baseline, Month 6, 12, 18, 24
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Pearson correlation coefficient between AIMS2 component score and DAS28-CRP score (AIMS2 component score vs DAS28-CRP) was calculated.
AIMS2: 78-item questionnaire assessing 12 scales.
Each item was scored as 0 (or 1, best situation) to 4 (worst situation).
Sub-total score of each of the 12 scales normalized to a maximum of 10.
Total score were calculated for AIMS2 Affect ([Level of tension + Mood]/2), AIMS2 Physical ([Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks]/6), and AIMS2 Symptom (Arthritis pain); total score range from 0 to 10, higher scores indicates worse situation DAS28-CRP was calculated from the number of SJC and TJC count using 28 joint count and CRP (mg/L).
Total score range: 0-10, higher score= more disease activity.
DAS28 (CRP): <3.2= low DA, >3.2 to 5.1 = moderate to high DA and <2.6 = remission.
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Baseline, Month 6, 12, 18, 24
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Spearman Correlation Coefficient Between Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation (DAS 28-ESR) and Visual Analog Scale (VAS) Fatigue Score
Periodo de tiempo: Baseline, Month 6, 12, 18, 24
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Spearman correlation coefficient between DAS28-ESR and VAS fatigue (DAS28-ESR vs VAS score) was calculated.
DAS28-ESR calculated from the number of SJC and TJC using the 28 joints count, ESR (mm/hour) and participant's assessment of disease activity VAS (scores ranging 0 [very well] to 100 mm [extremely bad]).
Total score range: 0-10, higher score= more disease activity.
DAS28-ESR <= 3.2 = low DA, DAS28 > 3.2 to 5.1 = moderate to high DA and VAS fatigue = Participants recorded their fatigue score on a range of 0 to 10, where higher score indicated higher intensity of fatigue.
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Baseline, Month 6, 12, 18, 24
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Spearman Correlation Coefficient Between Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (DAS 28-CRP) and Visual Analog Scale (VAS) Fatigue Score
Periodo de tiempo: Baseline, Month 6, 12, 18, 24
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Spearman correlation coefficient between DAS28-CRP and VAS score (DAS28-CRP vs VAS score) was calculated.
DAS28-CRP was calculated from the number of SJC and TJC count using 28 joint count and CRP (mg/L).
Total score range: 0-10, higher score= more disease activity.
DAS28 (CRP): <3.2= low DA, >3.2 to 5.1 = moderate to high DA and <2.6 = remission and VAS= Participants recorded their fatigue score on a range of 0 to 10, where higher score indicated higher intensity of fatigue.
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Baseline, Month 6, 12, 18, 24
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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 noviembre de 2010
Finalización primaria (Actual)
1 de febrero de 2014
Finalización del estudio (Actual)
1 de febrero de 2014
Fechas de registro del estudio
Enviado por primera vez
19 de agosto de 2011
Primero enviado que cumplió con los criterios de control de calidad
30 de enero de 2012
Publicado por primera vez (Estimar)
31 de enero de 2012
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
19 de febrero de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
3 de febrero de 2015
Última verificación
1 de febrero de 2015
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 0881A1-4748
- B1801046 (Otro identificador: Alias Study Number)
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. .
Ensayos clínicos sobre SC anti-TNF
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PfizerTerminado
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HaEmek Medical Center, IsraelUniversity of Toronto; Mount Sinai Hospital, CanadaTerminadoColitis ulcerosa | Terapia anti-TNF | Anastomosis anal con bolsa ileal (IPAA)
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TakedaTerminadoEnfermedades inflamatorias del intestino | Enfermedad de Crohn | Colitis UlcerativaPorcelana, Corea, república de, Taiwán, Federación Rusa, Pavo, Argentina, Colombia, México, Arabia Saudita, Singapur
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Children's Hospital Medical Center, CincinnatiNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)TerminadoArtritis reumatoide juvenil idiopáticaEstados Unidos
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Universidade Federal do Rio de JaneiroDesconocidoArtritis | Artritis psoriásicaBrasil
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Janssen Biotech, Inc.Terminado
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Fundación de Investigación Biomédica - Hospital...TerminadoEnfermedad de Crohn | Colitis ulcerosa | Enfermedad inflamatoria intestinalEspaña
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Opal Rheumatology Ltd.Merck Sharp & Dohme LLCDesconocidoArtritis Reumatoide | Artritis psoriásica | Espondiloartritis anquilosanteAustralia
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Hospices Civils de LyonRetirado
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University Hospital, LilleRetirado