An Observational Study in Clinical Practice Management of Patients With Biological Drugs in Monotherapy
15 de marzo de 2016 actualizado por: Hoffmann-La Roche
Study of the Profile and Clinical Management of Patients With Rheumatoid Arthritis Treated With Biologic Therapy Alone
This observational multicenter study will evaluate the management of disease and safety in clinical practice in patients with moderate to severe rheumatoid arthritis receiving any biological therapies in monotherapy.
Descripción general del estudio
Estado
Terminado
Condiciones
Tipo de estudio
De observación
Inscripción (Actual)
210
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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Alicante, España, 03010
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Burgos, España, 06006
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Caceres, España, 10310
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Cordoba, España, 14001
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Girona, España, 17007
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Madrid, España, 28006
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Madrid, España, 28034
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Madrid, España, 28905
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Madrid, España, 28007
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Madrid, España, 28222
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Malaga, España, 29005
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Murcia, España, 30008
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Palencia, España, 34005
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Sevilla, España, 41013
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Sevilla, España, 41018
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Tenerife, España, 38010
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Toledo, España, 45004
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Valencia, España, 46015
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Valladolid, España, 47005
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Zamora, España, 49022
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Zaragoza, España, 50009
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Alava
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Vitoria, Alava, España, 01009
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Alicante
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Elche, Alicante, España, 03203
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Asturias
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Oviedo, Asturias, España, 33006
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Badajoz
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Zafra, Badajoz, España, 06300
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Barcelona
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Sabadell, Barcelona, España, 08208
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Viladecans, Barcelona, España, 08840
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Cadiz
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Jerez de la Frontera, Cadiz, España, 11407
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Castellon
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Vinaroz, Castellon, España, 12500
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Granada
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Cenes de la vega, Granada, España, 18190
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Granda, Granada, España, 18190
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Guipuzcoa
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San Sebastian, Guipuzcoa, España, 20080
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Islas Baleares
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Ibiza, Islas Baleares, España, 07800
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Inca, Islas Baleares, España, 07300
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Manacor (Islas Baleares), Islas Baleares, España, 07500
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Jaen
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Jaén, Jaen, España, 23007
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La Coruña
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La Coruna, La Coruña, España, 15006
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Madrid
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Alcala de Henares, Madrid, España, 28805
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Malaga
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Benalmadena, Malaga, España, 29630
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Pontevedra
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Vigo, Pontevedra, España, 36214
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Valencia
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Gandia, Valencia, España, 46700
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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 moderate to severe rheumatoid arthritis
Descripción
Inclusion Criteria:
- Adult patients, >/=18 years of age
- Patients with moderate to severe rheumatoid arthritis who have had an inadequate response or intolerance to disease modifying antirheumatic drugs (DMARDs) or other biological drugs
- Patients treated with biologic DMARDs alone for at least 6 months
Exclusion Criteria:
- Patients not willing or unable to give written informed consent for participation in this study
- Patients who are participating in any clinical trial at the time of this study
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: Transversal
Cohortes e Intervenciones
Grupo / Cohorte |
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bDMARD Monotherapy
Patients with moderate to severe rheumatoid arthritis (RA) will be treated with bDMARD (biologic disease-modifying antirheumatic drug) monotherapy under routine clinical practice conditions at rheumatology clinics
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Number of Participants With Level of Education Completed
Periodo de tiempo: At Visit 1 (Single visit study)
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Level of education completed is a component of socio-demographic characteristics.
It is recorded as cannot read, no formal education, primary education or equivalent, general secondary education, vocational education, and higher education or equivalent.
Data were collected at study entry (Single visit study)
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At Visit 1 (Single visit study)
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Number of Participants With Smoking Habits
Periodo de tiempo: At Visit 1
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Smoking habits is a component of socio-demographic characteristics.
Participants' smoking status is recorded as non-smoker, smoker, and ex-smoker at Visit 1.
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At Visit 1
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Smoking-habit for Smokers or Ex-smokers (Packs in Years)
Periodo de tiempo: At Visit 1
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Smoking-habit included number of pack per years is reported.
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At Visit 1
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Smoking-habit or Smokers or Ex-smokers (Smoking/Quit Smoking )
Periodo de tiempo: At Visit 1
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Smoking-habit included years of smoking/quit smoking is reported for participants.
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At Visit 1
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Mean Time of Onset of Rheumatoid Arthritis
Periodo de tiempo: At Visit 1
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Onset of rheumatoid arthritis is a component of clinical characteristics.
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At Visit 1
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Number of Participants With Family History of Rheumatoid Arthritis
Periodo de tiempo: At Visit 1
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Family history is a component of clinical characteristics.
Participants who had a family history of rheumatoid arthritis is recorded as yes/no.
Also, family history related to parents, siblings, aunts and uncles, grandparents, or other is recorded.
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At Visit 1
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Number of Participants With Co-morbidities
Periodo de tiempo: At Visit 1
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Co-morbidity is a component of clinical characteristics It included stroke, heart failure (grades I, II, III or IV), ischemic heart disease, hypertension, dyslipidemia, osteoporosis, interstitial lung disease, chronic obstructive pulmonary disease (COPD), depression, diabetes mellitus, liver disease, serious infections, tuberculosis, hematological malignancies, solid tumors and others.
Participants were assessed into categories with associated co-morbidities as yes and no.
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At Visit 1
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Number of Participants With Extra-articular Manifestations at Visit 1
Periodo de tiempo: At Visit 1
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Extra-articular manifestations (EAMs) are a component of of clinical characteristics EAMs are symptoms and diseases that occur in parts of the body other than joints.
These included the presence of amyloidosis (rare disease that results from the buildup of misfolded proteins), anemia (deficiency of red cells in the blood), heart complications, lung complications, rheumatoid nodules (local swelling), felty's syndrome (presence of rheumatoid arthritis, an enlarged spleen, and an abnormally low white blood cell count), and secondary Sjogren's (an autoimmune disorder that damages moisture-producing glands, making it difficult to produce saliva and tears).
Participants were assessed into categories with extra-articular Manifestations as yes, no and missing nos.
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At Visit 1
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Mean Number of Painful and Swollen Joints at Visit 1
Periodo de tiempo: At Visit 1
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Participants were assessed for painful and swollen joints at Visit 1. Painful joint is the most specific clinical method to quantify abnormalities in participants with RA.
It reflects the amount of inflamed synovial tissue.
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At Visit 1
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Physician's Global Assessment of Disease Activity at Visit 1
Periodo de tiempo: At Visit 1
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The Physician's global assessment of disease activity is assessed using a 0 to 100 millimeter (mm) horizontal visual analogue scale (VAS).
The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity).
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At Visit 1
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Patient's Global Assessment of Disease Activity at Visit 1
Periodo de tiempo: At Visit 1
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Patient global assessment of disease activity visual analog scale is assessed using a 0 to 100 mm horizontal VAS.
The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity).
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At Visit 1
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Number of Participants With Hematology Parameters Values Falling Within Reference Values at Visit 1
Periodo de tiempo: At Visit 1
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Hematology parameters are considered as one of the component of clinical characteristics.
Hematology parameters included white blood cells (WBC), platelets, red blood cells (RBC), hemoglobin, hematocrit, neutrophils, basophils, eosinophils, lymphocytes, monocytes.
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At Visit 1
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Number of Participants With Biochemistry Parameters Values Falling Within Reference Values at Visit 1
Periodo de tiempo: At Visit 1
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Biochemistry parameters is considered as one of the component of clinical characteristics.
Biochemistry parameters included alanine amino transferase (ALT), aspartate amino transferase (AST), triglycerides, total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), and total lipids.
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At Visit 1
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Number of Participants With Presence/Absence Rheumatoid Factor and Anti-Cyclic Citrullinated Protein Antibodies
Periodo de tiempo: At Visit 1
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Rheumatoid Factor (RF) is the auto antibody directed against Immunoglobulin G and its concentration is observed in human serum or plasma.
Anti-Cyclic Citrullinated Protein Antibodies (Anti-CCP) antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants.
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At Visit 1
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Number of Participants With C-reactive Protein and Erythrocyte Sedimentation Rate Falling Within Reference Values at Visit 1
Periodo de tiempo: At Visit 1
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The test for C-reactive Protein (CRP) is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultra-sensitive assay.
A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Erythrocyte sedimentation rate (ESR) is a laboratory test that provides a non-specific measure of inflammation.
A higher rate is consistent with inflammation.
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At Visit 1
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Patient Pain Visual Analog Scale Score at Visit 1
Periodo de tiempo: At Visit 1
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Participants assessed their pain using a 0 to 10 horizontal visual analogue scale (VAS).
The left-hand extreme of the line equals 0 and is described as "no pain" and the right-hand extreme equals 10 as "unbearable pain"
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At Visit 1
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Number of Participants With Joint Damage at Visit 1
Periodo de tiempo: At Visit 1
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Number of participants with joint damage is recorded as yes and no.
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At Visit 1
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Mean Score on Disease Activity Score Based on 28-Joints Count at Visit 1
Periodo de tiempo: At Visit 1
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Disease activity score (DAS) 28 is a combined index for measuring disease activity in RA.
The index includes swollen (range 0-28) and tender (range 0-28) joint counts, acute phase response (ESR in mm/hr), and general health status (participant global assessment of disease activity using VAS, range 1-100 mm).
DAS28, which uses a 28-joint count, is derived from the original DAS, which includes a 44-swollen joint count.
The DAS28 scale ranges from 0 to 10, where higher scores indicate worsening.
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At Visit 1
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Number of Participants With Disease Activity Score by Categorization at Visit 1
Periodo de tiempo: At Visit 1
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DAS28 is divided into 4 categories as: remission <2.6, low activity 2.6-3.2,
moderate 3.2-5.1 and high >5.1.
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At Visit 1
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Mean Score on Clinical Disease Activity Index at Visit 1
Periodo de tiempo: At Visit 1
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Clinical disease activity index (CDAI) of participants is a composite index that is calculated as the sum of number of painful joint, number of swollen joint, patient's VAS (0-10 cm) assessment, physician global VAS assessment (0-10 cm).
The CDAI score ranges from 0 to 76, where lower scores indicate less disease activity.
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At Visit 1
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Number of Participants With Clinical Disease Activity by Categorization at Visit 1
Periodo de tiempo: At Visit 1
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CDAI is divided into 4 categories as: remission <2.8, low activity 2.8-10, moderate 10-22 and high>22.
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At Visit 1
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Mean Score on Simple Disease Activity Index at Visit 1
Periodo de tiempo: At Visit 1
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Simple Disease Activity Index (SDAI) is calculated by sum of number of painful joint and swollen joint count, patient and physician global assessment of disease activity (VAS 0-10 cm), and level of C-reactive protein in milligrams per deciliter (mg/dL).
SDAI total score ranges from 0 to 86, where higher scores indicates greater affect due to disease activity.
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At Visit 1
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Number of Participants With Simple Disease Activity Index Score by Categorization at Visit 1
Periodo de tiempo: At Visit 1
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SDAI is divided into 4 categories as: remission (<3.3), low activity (3.3-11), moderate activity (11-26) and high activity (>26).
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At Visit 1
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Number of Participants Prescribed First Synthetic Disease-Modifying Antirheumatic Drug Therapy Before the Study
Periodo de tiempo: At Visit 1
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Number of participants prescribed with first synthetic disease-modifying antirheumatic drug therapy (sDMARD) in monotherapy and in a combination before the study was presented.
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At Visit 1
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Mean Time Between Diagnosis and Prescription of First Synthetic Disease-Modifying Antirheumatic Drug or First Biologic Disease-Modifying Antirheumatic Drug
Periodo de tiempo: At Visit 1
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Mean time in months at Visit 1 between diagnosis and prescription of first sDMARD/ first bDMARD was presented.
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At Visit 1
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Number of Participants Who Received Each sDMARD Before The Study
Periodo de tiempo: At Visit 1
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Number of participants who previously received sDMARDs before the study in at Visit 1 was reported.
sDMARDS included azathioprine, penicillamine, sulfasalazine, hydroxychloroquine, gold salts, chloroquine, leflunomide, ciclosporin, methotrexate, and chlorambucil medications.
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At Visit 1
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Number of Participants Who Received Last sDMARD Prescribed Before the Study
Periodo de tiempo: At Visit 1
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Number of participants who previously received sDMARDs before the study in at Visit 1 was reported.
sDMARDS included azathioprine, penicillamine, sulfasalazine, hydroxychloroquine, gold salts, leflunomide, ciclosporin, methotrexate, and leflunomide + methotrexate.
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At Visit 1
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Number of Participants Prescribed First bDMARD Before the Study
Periodo de tiempo: At Visit 1
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Number of participants prescribed first bDMARD before the study was presented.
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At Visit 1
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Number of Participants Who Received Each bDMARD Before the Study
Periodo de tiempo: At Visit 1
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Number of participant who received bDMARD (etanercept, infliximab, golimumab, adalimumab, abatacept, tocilizumab, rituximab) before the study was reported in at Visit 1.
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At Visit 1
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Mean Time Between the Last sDMARD and bDMARD Received at Visit 1
Periodo de tiempo: At Visit 1
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Mean time between the last sDMARD and bDMARD received at Visit 1 was presented in months.
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At Visit 1
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Number of Participants With Changing the Previous sDMARD/ bDMARD
Periodo de tiempo: At Visit 1
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Any reasons for changing the previous sDMARD/bDMARD treatment were recorded as lack of efficacy, adverse events, intolerance, clinical improvement and other.
There may be more than one reason for changing sDMARD/ bDMARD per participant.
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At Visit 1
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Number of sDMARD and bDMARDs Received Before the Study Treatment (bDMARD Monotherapy)
Periodo de tiempo: At Visit 1
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Number of sDMARD and bDMARDs received by Participants before the study was presented
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At Visit 1
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Number of Participants Received sDMARD, sDMARD+ bDMARD or bDMARD Immediately Before the Study Treatment
Periodo de tiempo: At Visit 1
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At Visit 1
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Number of Participants Discontinued the Previous Treatment and Started the Study Treatment
Periodo de tiempo: At Visit 1
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The reasons for changing the previous sDMARD, sDMARD+ bDMARD or bDMARD treatment and starting the study treatment were recorded as lack of efficacy, adverse events, intolerance, clinical improvement, and other.
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At Visit 1
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Median Time Taking the Biologic Agent in Monotherapy Before the Study Treatment
Periodo de tiempo: At Visit 1
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Median time in months taking the Biologic Agent in monotherapy before the study was presented.
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At Visit 1
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Number of Participants Treated With Concomitant Medications Before the Study
Periodo de tiempo: At Visit 1
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Participants received concomitant medications (corticosteroids, non-steroidal anti-inflammatory drugs [NSAID], and other treatment) before the study were presented.
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At Visit 1
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Number of Participants Received Current bDMARD Treatment at the Time of the Study
Periodo de tiempo: At Visit 1
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Current bDMARD treatment included etanercept, infliximab, adalimumab, abatacept, tocilizumab, rituximab and certolizumab.
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At Visit 1
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Number of Participants Received Other Concomitant Treatments With the Current bDMARD Monotherapy
Periodo de tiempo: At Visit 1
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Other treatments included corticosteroids, NSAIDs and corticosteroid + NSAID.
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At Visit 1
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Number of Participants With Reasons for Starting Current Biologic Monotherapy
Periodo de tiempo: At Visit 1
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The reasons for changing current biologic treatment were recorded as lack of efficacy, adverse events, intolerance, clinical improvement and other.
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At Visit 1
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Number of Participants Who Received Tocilizumab, Anti-Tumour Necrosis Factor and Other as a Monotherapy at the Time of the Study
Periodo de tiempo: At Visit 1
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Participants who received tocilizumab, Anti-tumour necrosis factor (TNF) and Other treatment of monotherapy were reported.
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At Visit 1
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Mean Time of bDMARD Monotherapy Started at the Time of the Study Since Onset of RA
Periodo de tiempo: At Visit 1
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At Visit 1
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Number of sDMARD and bDMARDs Received Before the Study Treatment (Tocilizumab or Other Biologic Agent)
Periodo de tiempo: At Visit 1
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At Visit 1
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Mean Score on Disease Activity Score Based on 28-Joints Count, Clinical Disease Activity Index and Simple Disease Activity Index by Biologic Agent in Monotherapy at the Time of the Study
Periodo de tiempo: At Visit 1
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Mean score of DAS28 index, CDAI index, and SDAI index were recorded for participants who received biologic agent in monotherapy at the time of the study.
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At Visit 1
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Number of Participants With Categorization of Disease Activity Based on Disease Activity Score, Clinical Disease Activity Index Score and Simple Disease Activity Index Score
Periodo de tiempo: At Visit 1
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Mean score of categorization (remission/low activity and moderate/high activity) of DAS28 index, CDAI index, and SDAI index was recorded for participants who received biologic agent in monotherapy at the time of the study .
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At Visit 1
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Mean Number of Joint Count for Painful Joints and Swollen Joints by Biologic Agent in Monotherapy at the Time of the Study
Periodo de tiempo: At Visit 1
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Participants who received biologic agent in monotherapy at the time of the study were assessed for a number of painful joints (NPJ) and swollen joints (NSJ).
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At Visit 1
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Number of Participants Falling Within Reference Values For C-reactive Protein and Erythrocyte Sedimentation Rate by Biologic Agent in Monotherapy at the Time of the Study
Periodo de tiempo: At Visit 1
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Participants who received biologic agent in monotherapy at the time of the study were assessed for C-reactive Protein (CRP) and Erythrocyte Sedimentation Rate (ESR).
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At Visit 1
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Number of Participants With Adverse Events Leading to a Change of Treatment
Periodo de tiempo: At the time of change of treatment
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An Adverse Event was considered as 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.
Adverse events were collected as a reason for the change to monotherapy.
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At the time of change of treatment
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Number of Participants With Any Adverse Events and Any Serious Adverse Events
Periodo de tiempo: At the time of change of treatment (to the current treatment)
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An Any Adverse Events (AEs) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.
An Serious Adverse Events (SAEs) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.
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At the time of change of treatment (to the current treatment)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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 junio de 2012
Finalización primaria (Actual)
1 de junio de 2013
Finalización del estudio (Actual)
1 de junio de 2013
Fechas de registro del estudio
Enviado por primera vez
8 de agosto de 2012
Primero enviado que cumplió con los criterios de control de calidad
10 de agosto de 2012
Publicado por primera vez (Estimar)
14 de agosto de 2012
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
4 de abril de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
15 de marzo 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
- ML28356
- ROC-BIO-2011-01 (Otro identificador: Agencia Española del Medicamento y Productos Sanitarios)
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. .