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A Study Of CP-195543 And Celecoxib Dual Therapy In Subjects With Rheumatoid Arthritis

10 de setembro de 2014 atualizado por: Pfizer

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Of CP-195543 And Celecoxib Dual Therapy In The Treatment Of The Signs And Symptoms Of Rheumatoid Arthritis In Subjects Who Are Inadequately Controlled On Methotrexate

To evaluate the efficacy, safety and tolerability of CP-195543 and celecoxib dual therapy in subjects with rheumatoid arthritis

Visão geral do estudo

Status

Rescindido

Condições

Intervenção / Tratamento

Descrição detalhada

Trial enrollment was prematurely discontinued on December 3, 2007. The results of an interim efficacy and safety analysis demonstrated an overall poor tolerability profile and high discontinuation rate when dual therapy with CP-195543 and Celecoxib was administered. The decision to discontinue further enrollment in the trial was not based on any efficacy or serious safety concerns. Previously enrolled study participants continued in the study and the trial completed on February 27, 2008.

Tipo de estudo

Intervencional

Inscrição (Real)

70

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

  • Estados Unidos
    • Alabama
      • Huntsville, Alabama, Estados Unidos, 35801
        • Pfizer Investigational Site
    • Arizona
      • Scottsdale, Arizona, Estados Unidos, 85251
        • Pfizer Investigational Site
    • California
      • Upland, California, Estados Unidos, 91786
        • Pfizer Investigational Site
    • Florida
      • Boca Raton, Florida, Estados Unidos, 33486
        • Pfizer Investigational Site
      • Clearwater, Florida, Estados Unidos, 33765
        • Pfizer Investigational Site
      • Dunedin, Florida, Estados Unidos, 34698
        • Pfizer Investigational Site
      • Fort Lauderdale, Florida, Estados Unidos, 33334
        • Pfizer Investigational Site
      • Lake Mary, Florida, Estados Unidos, 32746
        • Pfizer Investigational Site
      • Miramar, Florida, Estados Unidos, 33025
        • Pfizer Investigational Site
      • New Port Richey, Florida, Estados Unidos, 34652
        • Pfizer Investigational Site
      • Orange City, Florida, Estados Unidos, 32763
        • Pfizer Investigational Site
      • Orlando, Florida, Estados Unidos, 32804
        • Pfizer Investigational Site
      • Port Richey, Florida, Estados Unidos, 34668
        • Pfizer Investigational Site
      • Sarasota, Florida, Estados Unidos, 34233
        • Pfizer Investigational Site
      • Sarasota, Florida, Estados Unidos, 34239
        • Pfizer Investigational Site
      • Tampa, Florida, Estados Unidos, 33614-7118
        • Pfizer Investigational Site
      • Venice, Florida, Estados Unidos, 34292
        • Pfizer Investigational Site
      • Vero Beach, Florida, Estados Unidos, 32960
        • Pfizer Investigational Site
    • Illinois
      • Moline, Illinois, Estados Unidos, 61265
        • Pfizer Investigational Site
      • Springfield, Illinois, Estados Unidos, 62704
        • Pfizer Investigational Site
    • Indiana
      • Indianapolis, Indiana, Estados Unidos, 46250
        • Pfizer Investigational Site
      • Munster, Indiana, Estados Unidos, 46321
        • Pfizer Investigational Site
    • Kentucky
      • Lexington, Kentucky, Estados Unidos, 40504
        • Pfizer Investigational Site
    • Louisiana
      • Covington, Louisiana, Estados Unidos, 70433
        • Pfizer Investigational Site
      • New Orleans, Louisiana, Estados Unidos, 70115
        • Pfizer Investigational Site
    • Maryland
      • Frederick, Maryland, Estados Unidos, 21702
        • Pfizer Investigational Site
    • Michigan
      • Kalamazoo, Michigan, Estados Unidos, 49009
        • Pfizer Investigational Site
    • Mississippi
      • Tupelo, Mississippi, Estados Unidos, 38801
        • Pfizer Investigational Site
    • Missouri
      • Springfield, Missouri, Estados Unidos, 65807
        • Pfizer Investigational Site
    • New York
      • Olean, New York, Estados Unidos, 14760
        • Pfizer Investigational Site
      • Rochester, New York, Estados Unidos, 14618
        • Pfizer Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Estados Unidos, 73139
        • Pfizer Investigational Site
    • Pennsylvania
      • Philladelphia, Pennsylvania, Estados Unidos, 19118
        • Pfizer Investigational Site
    • Tennessee
      • Knoxville, Tennessee, Estados Unidos, 37909-1600
        • Pfizer Investigational Site
      • Memphis, Tennessee, Estados Unidos, 38119
        • Pfizer Investigational Site
    • Texas
      • Houston, Texas, Estados Unidos, 77090
        • Pfizer Investigational Site
      • Killeen, Texas, Estados Unidos, 76549
        • Pfizer Investigational Site
      • San Antonio, Texas, Estados Unidos, 78217
        • Pfizer Investigational Site
    • Utah
      • Ogden, Utah, Estados Unidos, 84403
        • Pfizer 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:

  • A diagnosis of RA based upon the American college of Rheumatology 1987 revised criteria
  • Active disease at Screening
  • Stable dose of methotrexate between 10-25 mg/week oral or parenteral

Exclusion Criteria:

  • A diagnosis of any other inflammatory or secondary, noninflammatory arthritis that, in the opinion of the Investigator, would interfere with disease activity assessments
  • A history of hypersensitivity or allergic type reactions to cyclooxygenase inhibitors, opiates, aspirin or sulfonamides

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

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: Celecoxib
Celecoxib with placebo therapy.
Medicamento: celecoxib
Celecoxib is a nonsteroidal anit-inflammatory drug (NSAID) marketed worldwide (in the United States [US] as Celeberex) and approved for the relief of signs and symptoms of osteoarthritis.
Outro: Methotrexate
Background Methotrexate taken in both CP-195,543/Celecoxib and Celecoxib only arms.
Medicamento: Methotrexate
Methotrexate is a folate analogue that, based on it efficacy and safety in RA, is commonly used as frontline DMARD treatment in patients with moderate to severe disease who do not respond to NSAIDs alone.
Experimental: CP-195,543
CP-195,543 and Celecoxib dual therapy.
Medicamento: CP-195,543
CP-195543 is a potent and specific antagonist of the leukotriene B4 (LTB4) receptor.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12
Prazo: Week 12
ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).
Week 12

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 1, 2, 4 and 8
Prazo: Week 1, 2, 4, 8
ACR20 response: >=20% improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).
Week 1, 2, 4, 8
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response
Prazo: Week 1, 2, 4, 8, 12
ACR50 response: >=50% improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).
Week 1, 2, 4, 8, 12
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
Prazo: Week 1, 2, 4, 8, 12
ACR70 response: >=70% improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).
Week 1, 2, 4, 8, 12
Change From Baseline in Tender/Painful Joint Count (TJC) at Week 1, 2, 4, 8 and 12
Prazo: Baseline, Week 1, 2, 4, 8, 12
Participants were assessed for tender/painful joints using a 28-joint count comprised of left and right shoulders, elbows, wrists, proximal interphalangeal joints, metacarpophalangeal joints and knees. Artificial joints were not assessed.
Baseline, Week 1, 2, 4, 8, 12
Change From Baseline in Swollen Joint Count (SJC) at Week 1, 2, 4, 8 and 12
Prazo: Baseline, Week 1, 2, 4, 8, 12
Participants were assessed for swollen joints using a 28-joint count comprised of left and right shoulders, elbows, wrists, proximal interphalangeal joints, metacarpophalangeal joints and knees. Artificial joints were not assessed.
Baseline, Week 1, 2, 4, 8, 12
Change From Baseline in Patient's Assessment of Arthritis Pain at Week 1, 2, 4, 8 and 12
Prazo: Baseline, Week 1, 2, 4, 8, 12
Patient's assessment of arthritis pain was assessed using a 100 millimeter (mm) visual analogue scale (VAS) with range: 0 = no pain to 100 = worst possible pain.
Baseline, Week 1, 2, 4, 8, 12
Change From Baseline in Patient's Global Assessment of Arthritis at Week 1, 2, 4, 8 and 12
Prazo: Baseline, Week 1, 2, 4, 8, 12
Patient's global assessment of arthritic condition assessed all the ways participants' illness and health conditions affect them at the time of assessment. The response was scored on a 5-point scale: 1 = Very Good (Asymptomatic and no limitation of normal activities), 2 = Good (Mild symptoms and no limitation of normal activities), 3 = Fair (Moderate symptoms and limitation of some normal activities), 4 = Poor (Severe symptoms and inability to carry out most normal activities) and 5 = Very Poor (Very severe symptoms which are intolerable and inability to carry out all normal activities).
Baseline, Week 1, 2, 4, 8, 12
Change From Baseline in Physician's Global Assessment of Arthritis at Week 1, 2, 4, 8 and 12
Prazo: Baseline, Week 1, 2, 4, 8, 12
Investigator assessed overall appearance of arthritis at the time of the visit. The response was scored on a 5-point scale: 1 = Very Good (Asymptomatic and no limitation of normal activities), 2 = Good (Mild symptoms and no limitation of normal activities), 3 = Fair (Moderate symptoms and limitation of some normal activities), 4 = Poor (Severe symptoms and inability to carry out most normal activities) and 5 = Very Poor (Very severe symptoms which are intolerable and inability to carry out all normal activities).
Baseline, Week 1, 2, 4, 8, 12
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 1, 2, 4, 8 and 12
Prazo: Baseline, Week 1, 2, 4, 8, 12
Health Assessment Questionnaire-Disability Index (HAQ-DI): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3, where 0 = least difficulty and 3 = extreme difficulty.
Baseline, Week 1, 2, 4, 8, 12
Change From Baseline in C-Reactive Protein (CRP) at Week 1, 2, 4, 8 and 12
Prazo: Baseline, Week 1, 2, 4, 8, 12
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Baseline, Week 1, 2, 4, 8, 12
Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Week 1, 2, 4, 8 and 12
Prazo: Baseline, Week 1, 2, 4, 8, 12
DAS28-3 (CRP) was calculated from the SJC and TJC using the 28 joints count and CRP. It was calculated as DAS28-3 (CRP) = 1.15 + 1.10 * ([0.56 * square root of TJC] + [0.28 * square root of SJC] + [0.36 * natural logarithm of {CRP+1}]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28-3 (CRP) <= 3.2 implied low disease activity and >3.2 to 5.1 implied moderate to high disease activity, and DAS28-3 (CRP) <2.6 = remission.
Baseline, Week 1, 2, 4, 8, 12
Change From Baseline in Duration of Morning Stiffness at Week 1, 2, 4, 8 and 12
Prazo: Baseline, Week 1, 2, 4, 8, 12
Duration of morning stiffness was defined as the time elapsed between the time participant woke up and was able to resume normal activities without stiffness in hours (duration was recorded in hours to the nearest quarter. For those participants with unrelenting stiffness, duration was recorded as 24 hours).
Baseline, Week 1, 2, 4, 8, 12
Number of Participants Who Withdrew From Study Due to Lack of Efficacy
Prazo: Baseline up to Week 12
Baseline up to Week 12
Time to Withdrawal Due to Lack of Efficacy
Prazo: Baseline up to Week 12
Baseline up to Week 12
Number of Participants With Clinical Laboratory Abnormalities
Prazo: Baseline up to Week 13
Following parameters were analyzed for laboratory examination: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); liver function (aspartate aminotransferase, alanine aminotransferase, total bilirubin, lactate dehydrogenase, alkaline phosphatase, albumin, total protein); renal function (blood urea nitrogen, creatinine, uric acid); electrolytes (sodium, potassium, chloride, calcium, phosphate, bicarbonate); clinical chemistry (glucose, creatine kinase); immunology (CRP); urinalysis (dipstick [urine specific gravity, decimal logarithm of reciprocal of hydrogen ion activity {pH} of urine, glucose, protein, blood, ketones, bilirubin], microscopy [urine RBC, WBC, urate crystals, calcium, oxalate, miscellaneous [urine mucus and leucocytes]).
Baseline up to Week 13

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Prazo: Baseline up to 28 days after last dose
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Baseline up to 28 days after last dose
Number of Adverse Events by Severity
Prazo: Baseline up to 28 days after last dose
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs are classified according to the severity in 3 categories a) mild - AEs does not interfere with participant's usual function b) moderate - AEs interferes to some extent with participant's usual function c) severe - AEs interferes significantly with participant's usual function.
Baseline up to 28 days after last dose
Change From Baseline in Systolic and Diastolic Blood Pressure at Day 7, 14, 21, 28, 42, 56, 84 and 91
Prazo: Baseline, Day 7, 14, 21, 28, 42, 56, 84, 91
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were evaluated in sitting position.
Baseline, Day 7, 14, 21, 28, 42, 56, 84, 91
Change From Baseline in Heart Rate Day 7, 14, 21, 28, 42, 56, 84 and 91
Prazo: Baseline, Day 7, 14, 21, 28, 42, 56, 84, 91
Baseline, Day 7, 14, 21, 28, 42, 56, 84, 91
Number of Participants With Abnormal Electrocardiogram (ECG)
Prazo: Baseline up to Week 12
Criteria for potential clinical concern in ECG parameters: Maximum corrected QT interval (QTc) in range of 450 to less than 480 millisecond (msec), Maximum QTcB interval (Bazett's Correction) (msec) in range of 450 to less than 480 msec, Maximum QTcF interval (Fridericia's Correction) in range of 450 to less than 480 msec, maximum QTc interval increase from baseline in range of 30 to less than 60 msec and >=60 msec.
Baseline up to Week 12
Number of Participants With Categorical Vital Signs Data
Prazo: Baseline, Week 12
Number of participants with maximum increase from Baseline in sitting SBP and DBP of greater than or equal to 30 mmHg at Week 12 was reported.
Baseline, Week 12

Colaboradores e Investigadores

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

Patrocinador

Pfizer

Publicações e links úteis

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Links úteis

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 junho de 2006

Conclusão Primária (Real)

1 de dezembro de 2007

Conclusão do estudo (Real)

1 de fevereiro de 2008

Datas de inscrição no estudo

Enviado pela primeira vez

18 de janeiro de 2007

Enviado pela primeira vez que atendeu aos critérios de CQ

18 de janeiro de 2007

Primeira postagem (Estimativa)

19 de janeiro de 2007

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

25 de setembro de 2014

Última atualização enviada que atendeu aos critérios de controle de qualidade

10 de setembro de 2014

Última verificação

1 de setembro de 2014

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • A7701005

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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