Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared With Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA) (OSKIRA -4)
3 de abril de 2014 actualizado por: AstraZeneca
(OSKIRA-4): A Phase IIB, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Fostamatinib Disodium Monotherapy Compared With Adalimumab Monotherapy in Patients With Active Rheumatoid Arthritis
The purpose of the study is to evaluate the improvements in signs and symptoms of rheumatoid arthritis (RA) for fostamatinib compared to placebo or adalimumab in patients who are Disease-Modifying anti-rheumatic drug (DMARD) naïve, DMARD intolerant or have had an inadequate response to DMARDs.
The study will last for approximately six months
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
Sub-study:
Full title: Optional Genetic Research
Date: 10 September 2010
Version: 1
Objectives: To collect and store, with appropriate consent , DNA samples for future exploratory research into genes/genetic variation that may influence response (ie, absorption, distribution, metabolism and excretion, safety, tolerability and efficacy) to fostamatinib disodium and/or adalimumab; and/or susceptibility to, progression of and prognosis of RA
The main study recruitment is complete, and sub study recruitment will continue until the target is reached, estimated to be June 2013
Sub-study:
Full title: (Sub-study to OSKIRA-4): A Phase IIB, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Fostamatinib Disodium Monotherapy Compared with Placebo or Adalimumab Monotherapy in Patients with Active Rheumatoid Arthritis: Magnetic Resonance Imaging Sub-Study
Date: 21 March 2011
Version: 1
Primary objective: Assess the efficacy of fostamatinib in reducing joint synovial disease activity as measured by:
- Change from baseline to Week 6 (versus placebo) in OMERACT RAMRIS synovitis score.
Tipo de estudio
Intervencionista
Inscripción (Actual)
644
Fase
- Fase 2
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
-
-
-
Dresden, Alemania
- Research Site
-
Hamburg, Alemania
- Research Site
-
Muenchen, Alemania
- Research Site
-
-
-
-
-
Pleven, Bulgaria
- Research Site
-
Plovdiv, Bulgaria
- Research Site
-
Ruse, Bulgaria
- Research Site
-
Sevlievo, Bulgaria
- Research Site
-
Sofia, Bulgaria
- Research Site
-
Veliko Tarnovo, Bulgaria
- Research Site
-
-
-
-
Ontario
-
Mississauga, Ontario, Canadá
- Research Site
-
-
-
-
-
Trebisov, Eslovaquia
- Research Site
-
Trnava, Eslovaquia
- Research Site
-
-
-
-
Alabama
-
Birmingham, Alabama, Estados Unidos
- Research Site
-
-
Arizona
-
Glendale, Arizona, Estados Unidos
- Research Site
-
Mesa, Arizona, Estados Unidos
- Research Site
-
Phoenix, Arizona, Estados Unidos
- Research Site
-
Scottsdale, Arizona, Estados Unidos
- Research Site
-
-
California
-
Huntington Beach, California, Estados Unidos
- Research Site
-
Long Beach, California, Estados Unidos
- Research Site
-
-
Colorado
-
Colorado Springs, Colorado, Estados Unidos
- Research Site
-
-
Connecticut
-
Bridgeport, Connecticut, Estados Unidos
- Research Site
-
-
Florida
-
Daytona Beach, Florida, Estados Unidos
- Research Site
-
Jacksonville, Florida, Estados Unidos
- Research Site
-
Miami, Florida, Estados Unidos
- Research Site
-
Ocala, Florida, Estados Unidos
- Research Site
-
Palm Harbor, Florida, Estados Unidos
- Research Site
-
Pinellas Park, Florida, Estados Unidos
- Research Site
-
Venice, Florida, Estados Unidos
- Research Site
-
-
Illinois
-
Chicago, Illinois, Estados Unidos
- Research Site
-
-
Indiana
-
South Bend, Indiana, Estados Unidos
- Research Site
-
-
Kentucky
-
Bowling Green, Kentucky, Estados Unidos
- Research Site
-
Elizabethtown, Kentucky, Estados Unidos
- Research Site
-
-
Maryland
-
Oxon Hill, Maryland, Estados Unidos
- Research Site
-
-
Michigan
-
Kalamazoo, Michigan, Estados Unidos
- Research Site
-
-
Missouri
-
Richmond Heights, Missouri, Estados Unidos
- Research Site
-
-
Montana
-
Kalispell, Montana, Estados Unidos
- Research Site
-
-
New Hampshire
-
Nashua, New Hampshire, Estados Unidos
- Research Site
-
-
New Mexico
-
Albuquerque, New Mexico, Estados Unidos
- Research Site
-
Las Cruces, New Mexico, Estados Unidos
- Research Site
-
-
New York
-
Brooklyn, New York, Estados Unidos
- Research Site
-
-
North Carolina
-
Charlotte, North Carolina, Estados Unidos
- Research Site
-
-
Ohio
-
Perrysburg, Ohio, Estados Unidos
- Research Site
-
-
Pennsylvania
-
Duncansville, Pennsylvania, Estados Unidos
- Research Site
-
-
South Carolina
-
Greenville, South Carolina, Estados Unidos
- Research Site
-
-
Tennessee
-
Jackson, Tennessee, Estados Unidos
- Research Site
-
Knoxville, Tennessee, Estados Unidos
- Research Site
-
Memphis, Tennessee, Estados Unidos
- Research Site
-
-
Texas
-
Austin, Texas, Estados Unidos
- Research Site
-
Houston, Texas, Estados Unidos
- Research Site
-
Mesquite, Texas, Estados Unidos
- Research Site
-
Plano, Texas, Estados Unidos
- Research Site
-
San Antonio, Texas, Estados Unidos
- Research Site
-
-
-
-
-
Moscow, Federación Rusa
- Research Site
-
Nizhny Novgorod, Federación Rusa
- Research Site
-
Petrozavodsk, Federación Rusa
- Research Site
-
Ryazan, Federación Rusa
- Research Site
-
St. Petersburg, Federación Rusa
- Research Site
-
Voronezh, Federación Rusa
- Research Site
-
Yaroslavl, Federación Rusa
- Research Site
-
-
-
-
-
Balatonfured, Hungría
- Research Site
-
Balatonfüred, Hungría
- Research Site
-
Budapest, Hungría
- Research Site
-
Debrecen, Hungría
- Research Site
-
Zalaegerszeg, Hungría
- Research Site
-
-
-
-
-
Amsterdam, Países Bajos
- Research Site
-
-
-
-
-
Bytom, Polonia
- Research Site
-
Chelm Slaski, Polonia
- Research Site
-
Grodzisk Mazowiecki, Polonia
- Research Site
-
Sroda Wielkopolska, Polonia
- Research Site
-
Warszawa, Polonia
- Research Site
-
Wroclaw, Polonia
- Research Site
-
Zyrardow, Polonia
- Research Site
-
Łódź, Polonia
- Research Site
-
-
-
-
-
Basingstoke, Reino Unido
- Research Site
-
Eastbourne, Reino Unido
- Research Site
-
London, Reino Unido
- Research Site
-
Manchester, Reino Unido
- Research Site
-
Wolverhampton, Reino Unido
- Research Site
-
-
Berkshire
-
Reading, Berkshire, Reino Unido
- Research Site
-
-
Greater London
-
London, Greater London, Reino Unido
- Research Site
-
-
Sussex
-
Eastbourne, Sussex, Reino Unido
- Research Site
-
-
-
-
-
Brno, República Checa
- Research Site
-
Bruntal, República Checa
- Research Site
-
Hlucin, República Checa
- Research Site
-
Liberec, República Checa
- Research Site
-
Ostrava, República Checa
- Research Site
-
Ostrava - Poruba, República Checa
- Research Site
-
Ostrava - Trebovice, República Checa
- Research Site
-
Praha, República Checa
- Research Site
-
Praha 11, República Checa
- Research Site
-
Praha 2, República Checa
- Research Site
-
Praha 4, República Checa
- Research Site
-
Zlin, República Checa
- Research Site
-
-
-
-
-
Cape Town, Sudáfrica
- Research Site
-
Durban, Sudáfrica
- Research Site
-
Pretoria, Sudáfrica
- Research Site
-
Stellenbosch, Sudáfrica
- Research Site
-
-
Gauteng
-
Pretoria, Gauteng, Sudáfrica
- Research Site
-
-
Kwazulu Natal
-
Durban, Kwazulu Natal, Sudáfrica
- Research Site
-
-
Western Cape
-
Cape Town, Western Cape, Sudáfrica
- Research Site
-
-
-
-
-
Donetsk, Ucrania
- Research Site
-
Ivano-frankivsk, Ucrania
- Research Site
-
Kharkiv, Ucrania
- Research Site
-
Kyiv, Ucrania
- Research Site
-
Lutsk, Ucrania
- Research Site
-
Lviv, Ucrania
- Research Site
-
Odessa, Ucrania
- Research Site
-
Simferopol, Ucrania
- Research Site
-
Zaporyzhzhya, Ucrania
- Research Site
-
-
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
Descripción
Inclusion Criteria:
- Male or female aged 18 and over
- Active rheumatoid arthritis (RA) diagnosed after the age of 16 and diagnosis within 5 years prior to study visit 1 and inadequate response to treatment with a maximum 2 Disease-Modifying anti-rheumatic drug (DMARD) therapies, or diagnosis within 5 years prior to study visit 1 and intolerance to DMARD therapy, or diagnosis within 2 years prior to study visit 1 and no previous use of DMARDs
- 4 or more swollen joints and 4 or more tender/painful joints (from 28 joint count) and either Erythrocyte Sedimentation Rate (ESR) blood result of 28mm/h or more, or C-Reactive Protein (CRP) blood result of 10mg/L or more
- At least 2 of the following: documented history or current presence of positive rheumatoid factor (blood test), radiographic erosion within 12 months prior to study enrolment, presence of serum anti-cyclic citrullinated peptide antibodies (blood test)
Exclusion Criteria:
- Females who are pregnant or breast feeding
- Poorly controlled hypertension
- Liver disease or significant liver function test abnormalities
- Certain inflammatory conditions (other than rheumatoid arthritis), connective tissue diseases or chronic pain disorders
- Recent or significant cardiovascular disease
- Significant active or recent infection including tuberculosis
- Previously received treatment with a TNF alpha antagonist (including etanercept, certolizumab, adalimumab, infliximab, golimumab) or anakinra or previous treatment with other biological agent including rituximab, abatacept and tocilizumab
- Use of any DMARDs within 6 weeks before first study visit
- Severe renal impairment
- Neutropenia
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
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Dosing Group A
Oral treatment and subcutaneous injection
|
Fostamatinib 100mg twice daily and placebo injection once every two weeks
Fostamatinib 100mg twice daily / fostamatinib 150mg once daily and placebo injection once every two weeks
Fostamatinib 100mg twice daily / fostamatinib 100mg once daily and placebo injection once every two weeks.
|
|
Experimental: Dosing Group B
Oral treatment and subcutaneous injection
|
Fostamatinib 100mg twice daily and placebo injection once every two weeks
Fostamatinib 100mg twice daily / fostamatinib 150mg once daily and placebo injection once every two weeks
Fostamatinib 100mg twice daily / fostamatinib 100mg once daily and placebo injection once every two weeks.
|
|
Experimental: Dosing Group C
Oral treatment and subcutaneous injection
|
Fostamatinib 100mg twice daily and placebo injection once every two weeks
Fostamatinib 100mg twice daily / fostamatinib 150mg once daily and placebo injection once every two weeks
Fostamatinib 100mg twice daily / fostamatinib 100mg once daily and placebo injection once every two weeks.
|
|
Comparador activo: Dosing Group D
Oral treatment and subcutaneous injection
|
Adalimumab 40mg injection once every two weeks and placebo to fostamatinib twice daily.
Otros nombres:
|
|
Comparador de placebos: Dosing Group E
Oral treatment and subcutaneous injection
|
Placebo injection once every two weeks.
Placebo to fostamatinib for six weeks, followed by fostamatinib 100mg twice daily (Group F) / fostamatinib 100mg twice daily then 150mg once daily (Group G).
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
DAS28-CRP Score - Change From Baseline to Week 6 Compared to Placebo
Periodo de tiempo: Baseline and 6 weeks
|
DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment.
Scores can take any positive value with a lower value indicating a better clinical condition.
Mean changes from baseline in DAS28-CRP score are shown at each visit and are presented as decreases from baseline (defined as baseline minus post-baseline) with larger changes indicative of a better clinical condition.
ANCOVA = analysis of covariance, BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, LS = least squares, n/a = not applicable, PO = orally, QD = once a day, SC = subcutaneous.
|
Baseline and 6 weeks
|
|
DAS28-CRP Score - Change From Baseline to Week 24 Compared to Adalimumab
Periodo de tiempo: Baseline and 24 weeks
|
DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment.
Scores can take any positive value with a lower value indicating a better clinical condition.
Mean changes from baseline in DAS28-CRP score are shown at each visit and are presented as decreases from baseline (defined as baseline minus post-baseline) with larger changes indicative of a better clinical condition.
Non-responder imputation has been applied by carrying the baseline observation forward.
ANCOVA = analysis of covariance, BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, LS = least squares, n/a = not applicable, PO = orally, QD = once a day, SC = subcutaneous.
|
Baseline and 24 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
DAS28 EULAR Response at Week 6
Periodo de tiempo: 6 weeks
|
Change in DAS28 was derived for each post baseline scheduled assessment and categorised using the European League Against Rheumatism (EULAR) response criteria.
Non-responder imputation has been applied by carrying the baseline observation forward.
bid = twice daily, DAS28 = Disease Activity Score based on a 28-joint count, DMARD = disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, qd = once a day, SC = subcutaneous.
|
6 weeks
|
|
DAS28 EULAR Response at Week 24
Periodo de tiempo: 24 weeks
|
Change in DAS28 was derived for each post baseline scheduled assessment and categorised using the European League Against Rheumatism (EULAR) response criteria.
Non-responder imputation has been applied by carrying the baseline observation forward.
bid = twice daily, DAS28 = Disease Activity Score based on a 28-joint count, DMARD = disease-modifying anti-rheumatic drug, OR = odds ratio, PO = orally, qd = once a day, SC = subcutaneous.
|
24 weeks
|
|
Proportion of Patients Achieving ACR20 up to Week 24
Periodo de tiempo: 6 and 24 weeks
|
ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function.
Non-responder imputation has been applied by carrying the baseline observation forward.
BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous.
|
6 and 24 weeks
|
|
Proportion of Patients Achieving ACR50 up to Week 24
Periodo de tiempo: 6 and 24 weeks
|
ACR50: American College of Rheumatology 50% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function.
Non-responder imputation has been applied by carrying the baseline observation forward.
BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous.
|
6 and 24 weeks
|
|
Proportion of Patients Achieving ACR70 up to Week 24
Periodo de tiempo: 6 and 24 weeks
|
ACR70: American College of Rheumatology 70% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function.
Non-responder imputation has been applied by carrying the baseline observation forward.
BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous.
|
6 and 24 weeks
|
|
ACRn - Comparison Between Fostamatinib and Placebo at Week 6
Periodo de tiempo: Baseline and 6 weeks
|
ACRn: American College of Rheumatology Index of RA improvement, based on smallest percentage improvement in the count of swollen joints (out of 28 joints), count of tender joints (out of 28 joints) or in blood test measures of inflammation (such as CRP) or the physician and patient's own asessment of disease activity, pain and physical function.
Scores are reported as a percentage improvement on a scale of -100 to +100, with larger values representing a better clinical outcome.
Non-responder imputation has been applied by carrying the baseline observation forward.
BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous.
Mean refers to change at Week 6. Treatment difference: difference between fostamatinib and placebo groups.
|
Baseline and 6 weeks
|
|
ACRn - Comparison Between Fostamatinib and Adalimumab at Week 24
Periodo de tiempo: Baseline and 24 weeks
|
ACRn: American College of Rheumatology Index of RA improvement, based on smallest percentage improvement in the count of swollen joints (out of 28 joints), count of tender joints (out of 28 joints) or in blood test measures of inflammation (such as CRP) or the physician and patient's own asessment of disease activity, pain and physical function.
Scores are reported as a percentage improvement on a scale of -100 to +100, with larger values representing a better clinical outcome.
Non-responder imputation has been applied by carrying the baseline observation forward.
BID = twice daily, CRP = C-reactive protein, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous.
Mean refers to change at Week 24.
Treatment difference: difference between fostamatinib and adalimumab groups.
|
Baseline and 24 weeks
|
|
HAQ-DI - Comparison of the Change From Baseline Between Fostamatinib and Placebo at Week 6
Periodo de tiempo: Baseline and 6 weeks
|
HAQ-DI: Health Assessment Questionnaire - Disability Index, a measure of physical function.
The HAQ-DI score is calculated by summing the category scores from 8 sub-categories (ie, scores for patient ability in dressing and grooming, rising, eating, walking, hygiene, reach, grip and common daily activities) and dividing by the number of categories completed.
The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability.
Non-responder imputation has been applied by carrying the baseline observation forward.
ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, LS = least squares, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous.
|
Baseline and 6 weeks
|
|
HAQ-DI - Comparison of the Change From Baseline Between Fostamatinib and Adalimumab at Week 24
Periodo de tiempo: Baseline and 24 weeks
|
HAQ-DI: Health Assessment Questionnaire - Disability Index, a measure of physical function.
The HAQ-DI score is calculated by summing the category scores from 8 sub-categories (ie, scores for patient ability in dressing and grooming, rising, eating, walking, hygiene, reach, grip and common daily activities) and dividing by the number of categories completed.
The HAQ-DI score takes values between 0 and 3, with a higher score indicating greater disability.
Non-responder imputation has been applied by carrying the baseline observation forward.
ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, LS = least squares, n/a = not applicable, PO = orally, qd = once a day, SC = subcutaneous.
|
Baseline and 24 weeks
|
|
SF-36 - Comparison of the Change in PCS From Baseline Between Fostamatinib and Adalimumab at Week 24
Periodo de tiempo: Baseline and 24 weeks
|
SF-36: 36-item Short Form Health Survey, a measure of health-related QoL.
Scores for 8 sub-domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Function, Role-Emotional & Mental Health) are derived & normalised to a scale of 0-100.
Physical & Mental Component Scores (PCS & MCS) are derived by multiplying each of these 8 scores by a constant, summing them & standardising against a population with mean of 50, standard deviation of 10.
Higher scores represent a better QoL.
Mean changes from baseline score are presented at each visit as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition.
Non-responder imputation applied by carrying the baseline observation forward.
ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, LS = least squares, PO = orally, QD = once a day, QoL = quality of life, SC = subcutaneous.
|
Baseline and 24 weeks
|
|
SF-36 - Comparison of the Change in MCS From Baseline Between Fostamatinib and Adalimumab at Week 24
Periodo de tiempo: Baseline and 24 weeks
|
SF-36: 36-item Short Form Health Survey, a measure of health-related QoL.
Scores for 8 sub-domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Function, Role-Emotional & Mental Health) are derived & normalised to a scale of 0-100.
Physical & Mental Component Scores (PCS & MCS) are derived by multiplying each of these 8 scores by a constant, summing them & standardising against a population with mean of 50, standard deviation of 10.
Higher scores represent a better QoL.
Mean changes from baseline score are presented at each visit as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition.
Non-responder imputation applied by carrying the baseline observation forward.
ANCOVA = analysis of covariance, BID = twice daily, DMARD = disease-modifying anti-rheumatic drug, IR = inadequate response, LS = least squares, PO = orally, QD = once a day, QoL = quality of life, SC = subcutaneous.
|
Baseline and 24 weeks
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Neil MacKillop, MD PhD, AstraZeneca
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 2011
Finalización primaria (Actual)
1 de octubre de 2012
Finalización del estudio (Actual)
1 de agosto de 2013
Fechas de registro del estudio
Enviado por primera vez
17 de diciembre de 2010
Primero enviado que cumplió con los criterios de control de calidad
21 de diciembre de 2010
Publicado por primera vez (Estimar)
22 de diciembre de 2010
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
6 de mayo de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
3 de abril de 2014
Última verificación
1 de abril de 2014
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- D4300C00004
- 2010-023692-26 (Número EudraCT)
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. .