Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

A Single Dose Of Compound SB-681323 Compared To Prednisolone On A Protein That Is an Indicator For Rheumatoid Arthritis

27 de julho de 2017 atualizado por: GlaxoSmithKline

A Randomised, Placebo-controlled, Parallel Group Single Dose Study of SB681323 in Patients With Active RA to Investigate the CRP Dose Response Relationship

This study is designed to compare a range of doses of SB-681323 with prednisolone, which has known effects on rheumatoid arthritis patients. By comparing the two drugs and their effects on blood proteins that indicate for rheumatoid arthritis, we hope to ascertain information on the most effective dose of SB-681323 to use in future.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

77

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
      • Berlin, Alemanha, 14059
        • GSK Investigational Site
      • Berlin, Alemanha, 13125
        • GSK Investigational Site
      • Berlin, Alemanha, 14109
        • GSK Investigational Site
      • Berlin, Alemanha, 12163
        • GSK Investigational Site
    • Baden-Wuerttemberg
      • Villingen-Schwenningen, Baden-Wuerttemberg, Alemanha, 78054
        • GSK Investigational Site
    • Niedersachsen
      • Hildesheim, Niedersachsen, Alemanha, 31134
        • GSK Investigational Site
    • Sachsen
      • Chemnitz, Sachsen, Alemanha, 09111
        • GSK Investigational Site
      • Leipzig, Sachsen, Alemanha, 04107
        • GSK Investigational Site
      • Leipzig, Sachsen, Alemanha, 04229
        • GSK Investigational Site
  • Austrália
    • New South Wales
      • Darlinghurst, New South Wales, Austrália, 2010
        • GSK Investigational Site
    • Queensland
      • Douglas, Queensland, Austrália, 4814
        • GSK Investigational Site
      • Woolloongabba, Queensland, Austrália, 4102
        • GSK Investigational Site
    • South Australia
      • Daw Park, South Australia, Austrália, 5041
        • GSK Investigational Site
      • Woodville, South Australia, Austrália, 5011
        • GSK Investigational Site
    • Tasmania
      • Hobart, Tasmania, Austrália, 7000
        • GSK Investigational Site
    • Western Australia
      • Shenton Park, Western Australia, Austrália, 6008
        • GSK Investigational Site
  • Federação Russa
      • Ekaterinburg, Federação Russa, 620102
        • GSK Investigational Site
      • Moscow, Federação Russa, 115522
        • GSK Investigational Site
      • Ryazan, Federação Russa, 390026
        • GSK Investigational Site
      • Yaroslavl, Federação Russa, 150003
        • GSK Investigational Site
  • França
      • Montpellier Cedex 5, França, 34295
        • GSK Investigational Site
    • Picardie
      • Amiens, Picardie, França, 80054
        • GSK Investigational Site
  • Reino Unido
      • Oxford, Reino Unido, OX3 7LP
        • GSK Investigational Site
      • Sheffield, Reino Unido, S10 2RX
        • GSK Investigational Site
    • Cambridgeshire
      • Cambridge, Cambridgeshire, Reino Unido, CB2 0QQ
        • GSK Investigational Site
    • Lancashire
      • Wigan, Lancashire, Reino Unido, WN6 9EP
        • GSK Investigational Site
    • Merseyside
      • Liverpool, Merseyside, Reino Unido, L9 7AL
        • GSK Investigational Site
    • Northumberland
      • Newcastle, Northumberland, Reino Unido, NE1 4LP
        • GSK Investigational 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:

  • Must have a diagnosis of RA according to the revised 1987 criteria of the American College of Rheumatology.
  • Must have 3 or more swollen or 3 or more tender/painful joints at screening.
  • Must be on stable weekly methotrexate (2.5mg - 25mg) for at least eight weeks prior to screening.

Exclusion criteria:

  • Must not be morbidly obese.

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: Dobro

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Analysis for C-Reactive protein (CRP) levels 72 hours post-dose following SB-681323
Prazo: Day 3 (at 72 hour)
CRP levels were compared between SB-681323 and placebo 72 hours post-dose. The ratio of the dose response relationship of placebo and 7.5mg, 15mg and 25mg of SB-681323 has been presented.
Day 3 (at 72 hour)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Analysis of CRP levels 24 and 48 hours post-dose following SB-681323
Prazo: Day 1 (at 24 hour) and Day 2 (at 48 hour)
CRP levels were compared between SB-681323 and placebo 24 and 48 hours post-dose. The ratio of the dose response relationship of placebo and 7.5mg, 15mg and 25mg of SB-681323 has been presented.
Day 1 (at 24 hour) and Day 2 (at 48 hour)
Analysis of Interleukin (IL)-6 levels up to 72 hours post-dose following SB-681323
Prazo: Upto Day 3 (at 1, 3, 24 and 72 hour)
A blood sample of approximately 5 milliliter (mL) was taken for measurement of serum markers. IL-6 measurements were performed at 1 hour, 3, hours, 24 hours and 72 hours post-dose. The ratio of the dose response relationship of placebo and 7.5mg, 15mg and 25mg of SB-681323 has been presented.
Upto Day 3 (at 1, 3, 24 and 72 hour)
Number of participants with adverse events (AE) and serious adverse events (SAE)
Prazo: Upto Day 3 (72 hours)
An AE 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 related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as 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, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury. There were no SAEs reported in this study.
Upto Day 3 (72 hours)
Change from Baseline in vital sign systolic blood pressure (SBP) and diastolic blood pressure (DBP)
Prazo: Baseline (at pre-dose Day 0) and Day 3 (at 90 minutes, 3 hour, 24 and 72 hour)
Supine vital signs SBP and DBP were recorded whilst the participant was in a supine position (participant lying flat with maximum one pillow) having rested in that position for at least 10 minutes before each reading. Measurements were performed at 90 minutes, 3 hours, 24 hours and 72 hours post-dose. Baseline was defined as assessment performed pre-dose at Day 0. Change from Baseline was calculated by subtracting the Baseline value from the individual post-randomization values at the time of assessment.
Baseline (at pre-dose Day 0) and Day 3 (at 90 minutes, 3 hour, 24 and 72 hour)
Change from Baseline in vital sign heart rate
Prazo: Baseline (at pre-dose Day 0) and Day 3 (at 90 minutes, 3 hour, 24 and 72 hour)
Supine vital signs (heart rate) was recorded whilst the participant was in a supine position (participant lying flat with maximum one pillow) having rested in that position for at least 10 minutes before each reading. Measurements were performed at 90 minutes, 3 hours, 24 hours and 72 hours post-dose. Baseline was defined as assessment performed pre-dose at Day 0. Change from Baseline was calculated by subtracting the Baseline value from the individual post-randomization values at the time of assessment.
Baseline (at pre-dose Day 0) and Day 3 (at 90 minutes, 3 hour, 24 and 72 hour)
Number of participants with abnormal electrocardiogram (ECG) findings
Prazo: Day 1 (pre-dose, 1 hour and 3 hour)
Full 12-lead ECGs were recorded using an ECG machine that automatically calculated the pulse rate and measured PR, RR, QRS, QT, QTc(b) intervals (Bazett's correction was applied to QTc measurements). Measurements were carried out at pre-dose, 1 hour and 3 hours on Day 1. ECG findings were characterized as abnormal-not clinically significant (A-NCS) and abnormal-clinically significant (A-CS). Data has been presented for A-NCS findings on Day 1.
Day 1 (pre-dose, 1 hour and 3 hour)
Number of participants with clinical chemistry data outside the clinical concern range
Prazo: Upto Day 3 (pre-dose, 24, 48 and 72 hours
Clinical chemistry parameters included albumin, alkaline phosphatase, alanine amino transferase, indirect bilirubin, calcium, chloride, creatinine, gamma glutamyl transferase, glucose, potassium, lactate dehydrogenase, triglycerides. Measurements were carried out at pre-dose, 24 hours, 48 hours and 72 hours. Data for number of participants with values outside clinical concern range defined as high and low have been presented.
Upto Day 3 (pre-dose, 24, 48 and 72 hours
Number of participants with hematology data outside the clinical concern
Prazo: Upto Day 3 (pre-dose, 24 and 72 hours)
Hematology parameters included eosinophils, hemoglobin, hematocrit, lymphocytes, mean corpuscle hemoglobin, mean corpuscle volume, platelet count, reticulocytes, white blood cell count (WBC). Measurements were carried out at pre-dose, 24 hours and 72 hours. Data for number of participants with values outside clinical concern range defined as high and low have been presented.
Upto Day 3 (pre-dose, 24 and 72 hours)
Number of participants with abnormal urinalysis dipstick results
Prazo: Upto Day 3 (pre-dose, 24 and 72 hours)
Approximately 10-20 mL mid-stream urine was collected into a sterile container and was screened by dipstick for: occult blood, proteins, ketones, glucose, red blood cells (RBC) and WBC. Sediment microscopy was performed only if any of the Multi-stick tests were abnormal. In such cases, microscopy was performed for: WBC, RBC, hyaline casts, granular casts, cellular casts. Data for number of participants with abnormal urinalysis results for positive parameters as assessed by dipstick and microscopic analysis have been presented.
Upto Day 3 (pre-dose, 24 and 72 hours)
Whole blood messenger RNA (mRNA) levels of tumor necrosis factor alpha [TNF-α], IL-8, IL-1β and Cyclo-oxygenase-2 [COX-2] (and other genes implicated in the pathogenesis of RA or genes involved in the mode of action of the compounds administered)
Prazo: Pre-dose, 45 minutes, 90 minutes and 3 hours on Day 1
Blood samples were taken for extraction of whole blood mRNA (2 x 2.5mL PAXgene tubes). The samples were taken at the time-points pre-dose, 45 minutes, 90 minutes and 3 hours. Messenger RNA levels for various markers was measured. These markers included Prednisolone markers: DDIT4, DUSP1, FKBP5, GILZ, IL1R2, TXNIP, ZNF145 and p38 markers: COX2, IFI30, IL1b, IL6, IL8, TNF. An aliquot of mRNA was stored for later analysis of other genes associated with the pathogenesis of RA and in the mode of action of the compounds administered.
Pre-dose, 45 minutes, 90 minutes and 3 hours on Day 1

Colaboradores e Investigadores

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

Patrocinador

GlaxoSmithKline

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 (Real)

21 de junho de 2005

Conclusão Primária (Real)

3 de agosto de 2006

Conclusão do estudo (Real)

3 de agosto de 2006

Datas de inscrição no estudo

Enviado pela primeira vez

24 de agosto de 2005

Enviado pela primeira vez que atendeu aos critérios de CQ

24 de agosto de 2005

Primeira postagem (Estimativa)

25 de agosto de 2005

Atualizações de registro de estudo

Última Atualização Postada (Real)

31 de julho de 2017

Última atualização enviada que atendeu aos critérios de controle de qualidade

27 de julho de 2017

Última verificação

1 de julho de 2017

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • RA1104046

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 .

Ensaios clínicos em Prednisolona

Pesquisar ensaios semelhantes

Patrocinadores e Colaboradores

Condições médicas

Intervenções de drogas

CROs by country

CROs in Venezuela

Condições

Doenças Raras

Intervenções de drogas

Suplementos Alimentares

Patrocinador / Colaboradores

Localizações

3
Se inscrever