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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 atualizado 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

Visão geral do estudo

Status

Rescindido

Condições

Intervenção / Tratamento

Descrição detalhada

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 estudo

Intervencional

Inscrição (Real)

644

Estágio

  • Fase 2

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Alemanha
      • Dresden, Alemanha
        • Research Site
      • Hamburg, Alemanha
        • Research Site
      • Muenchen, Alemanha
        • Research Site
  • Bulgária
      • Pleven, Bulgária
        • Research Site
      • Plovdiv, Bulgária
        • Research Site
      • Ruse, Bulgária
        • Research Site
      • Sevlievo, Bulgária
        • Research Site
      • Sofia, Bulgária
        • Research Site
      • Veliko Tarnovo, Bulgária
        • Research Site
  • Canadá
    • Ontario
      • Mississauga, Ontario, Canadá
        • Research Site
  • Eslováquia
      • Trebisov, Eslováquia
        • Research Site
      • Trnava, Eslováquia
        • Research Site
  • Estados Unidos
    • 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
  • Federação Russa
      • Moscow, Federação Russa
        • Research Site
      • Nizhny Novgorod, Federação Russa
        • Research Site
      • Petrozavodsk, Federação Russa
        • Research Site
      • Ryazan, Federação Russa
        • Research Site
      • St. Petersburg, Federação Russa
        • Research Site
      • Voronezh, Federação Russa
        • Research Site
      • Yaroslavl, Federação Russa
        • Research Site
  • Holanda
      • Amsterdam, Holanda
        • Research Site
  • Hungria
      • Balatonfured, Hungria
        • Research Site
      • Balatonfüred, Hungria
        • Research Site
      • Budapest, Hungria
        • Research Site
      • Debrecen, Hungria
        • Research Site
      • Zalaegerszeg, Hungria
        • Research Site
  • Polônia
      • Bytom, Polônia
        • Research Site
      • Chelm Slaski, Polônia
        • Research Site
      • Grodzisk Mazowiecki, Polônia
        • Research Site
      • Sroda Wielkopolska, Polônia
        • Research Site
      • Warszawa, Polônia
        • Research Site
      • Wroclaw, Polônia
        • Research Site
      • Zyrardow, Polônia
        • Research Site
      • Łódź, Polônia
        • Research Site
  • Reino Unido
      • 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
  • República Checa
      • 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
  • Ucrânia
      • Donetsk, Ucrânia
        • Research Site
      • Ivano-frankivsk, Ucrânia
        • Research Site
      • Kharkiv, Ucrânia
        • Research Site
      • Kyiv, Ucrânia
        • Research Site
      • Lutsk, Ucrânia
        • Research Site
      • Lviv, Ucrânia
        • Research Site
      • Odessa, Ucrânia
        • Research Site
      • Simferopol, Ucrânia
        • Research Site
      • Zaporyzhzhya, Ucrânia
        • Research Site
  • África do Sul
      • Cape Town, África do Sul
        • Research Site
      • Durban, África do Sul
        • Research Site
      • Pretoria, África do Sul
        • Research Site
      • Stellenbosch, África do Sul
        • Research Site
    • Gauteng
      • Pretoria, Gauteng, África do Sul
        • Research Site
    • Kwazulu Natal
      • Durban, Kwazulu Natal, África do Sul
        • Research Site
    • Western Cape
      • Cape Town, Western Cape, África do Sul
        • Research Site

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Dosing Group A
Oral treatment and subcutaneous injection
Medicamento: Fostamatinib and placebo injections
Fostamatinib 100mg twice daily and placebo injection once every two weeks
Medicamento: Fostamatinib and placebo injections
Fostamatinib 100mg twice daily / fostamatinib 150mg once daily and placebo injection once every two weeks
Medicamento: Fostamatinib and placebo injections
Fostamatinib 100mg twice daily / fostamatinib 100mg once daily and placebo injection once every two weeks.
Experimental: Dosing Group B
Oral treatment and subcutaneous injection
Medicamento: Fostamatinib and placebo injections
Fostamatinib 100mg twice daily and placebo injection once every two weeks
Medicamento: Fostamatinib and placebo injections
Fostamatinib 100mg twice daily / fostamatinib 150mg once daily and placebo injection once every two weeks
Medicamento: Fostamatinib and placebo injections
Fostamatinib 100mg twice daily / fostamatinib 100mg once daily and placebo injection once every two weeks.
Experimental: Dosing Group C
Oral treatment and subcutaneous injection
Medicamento: Fostamatinib and placebo injections
Fostamatinib 100mg twice daily and placebo injection once every two weeks
Medicamento: Fostamatinib and placebo injections
Fostamatinib 100mg twice daily / fostamatinib 150mg once daily and placebo injection once every two weeks
Medicamento: Fostamatinib and placebo injections
Fostamatinib 100mg twice daily / fostamatinib 100mg once daily and placebo injection once every two weeks.
Comparador Ativo: Dosing Group D
Oral treatment and subcutaneous injection
Medicamento: Adalimumab and placebo of fostamatinib
Adalimumab 40mg injection once every two weeks and placebo to fostamatinib twice daily.
Outros nomes:
  • Humira®
Comparador de Placebo: Dosing Group E
Oral treatment and subcutaneous injection
Medicamento: Placebo of fostamatinib, fostamatinib, and placebo injections
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).

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
DAS28-CRP Score - Change From Baseline to Week 6 Compared to Placebo
Prazo: 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
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
DAS28 EULAR Response at Week 6
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

AstraZeneca

Investigadores

  • Diretor de estudo: Neil MacKillop, MD PhD, AstraZeneca

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de janeiro de 2011

Conclusão Primária (Real)

1 de outubro de 2012

Conclusão do estudo (Real)

1 de agosto de 2013

Datas de inscrição no estudo

Enviado pela primeira vez

17 de dezembro de 2010

Enviado pela primeira vez que atendeu aos critérios de CQ

21 de dezembro de 2010

Primeira postagem (Estimativa)

22 de dezembro de 2010

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

6 de maio de 2014

Última atualização enviada que atendeu aos critérios de controle de qualidade

3 de abril de 2014

Última verificação

1 de abril de 2014

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • D4300C00004
  • 2010-023692-26 (Número EudraCT)

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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