Study of CE-224,535 A Twice Daily Pill To Control Rheumatoid Arthritis In Patients Who Have Not Totally Improved With Methotrexate
9 de março de 2022 atualizado por: Pfizer
A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF CE-224,535, AN ANTAGONIST OF THE P2X7 RECEPTOR, IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS IN SUBJECTS WHO ARE INADEQUATELY CONTROLLED ON METHOTREXATE
CE-224,535 is known to block a chemical that acts as a gateway to some of your immune cells.
Blocking this gateway prevents the cells from pushing out 2 chemicals called IL-1 and IL-18 that are known to cause some of the inflammation seen in rheumatoid arthritis.
It is hoped that taking this drug will reduce the symptoms of rheumatoid arthritis
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
100
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
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Santiago, RM
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Providencia, Santiago, RM, Chile, 7530206
- Clínica Santa María, Sección Reumatología
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A Coruña, Espanha, 15006
- Complexo Hospitalario Universitario A Coruña
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Madrid, Espanha, 28007
- Hospital General Universitario Gregorio Marañon
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A Coruña
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Santiago de Compostela, A Coruña, Espanha, 15705
- Hospital Nuestra Señora de La Esperanza
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Arizona
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Mesa, Arizona, Estados Unidos, 85202
- Arizona Arthritis & Rheumatology Associates, P.C.
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Florida
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DeBary, Florida, Estados Unidos, 32713
- Omega Research Consultants LLC
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Lake Mary, Florida, Estados Unidos, 32746
- Florida Arthritis Center
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Tampa, Florida, Estados Unidos, 33614
- Tampa Medical Group, Pa
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Indiana
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Avon, Indiana, Estados Unidos, 46123
- American Health Network
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Louisiana
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New Orleans, Louisiana, Estados Unidos, 70115
- George Stanley Walker, MD
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New Orleans, Louisiana, Estados Unidos, 70115
- Best Clinical Trials, LLC (Administrative Only)
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New Orleans, Louisiana, Estados Unidos, 70115
- Majid Abdul Jawad, MD
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Maryland
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Frederick, Maryland, Estados Unidos, 21702
- The Arthritis and Osteoporosis Center of Maryland
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Missouri
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Columbia, Missouri, Estados Unidos, 65212
- University of Missouri-Columbia
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Columbia, Missouri, Estados Unidos, 65203
- University Physicians
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Nevada
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Reno, Nevada, Estados Unidos, 89502
- Arthritis Center of Reno
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45242
- New Horizons Clinical Research
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Washington
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Spokane, Washington, Estados Unidos, 99204-2336
- Arthritis Northwest
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D.f.
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Mexico, D.f., México, 03300
- Investigadores Clinicos Asociados
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Krakow, Polônia, 31-501
- Krakowskie Centrum Medyczne NZOZ
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Poznan, Polônia, 60-356
- Zaklad Reumatologii i Immunologii Klinicznej
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Poznan, Polônia, 61-545
- Oddzial Reumatologiczno-Rehabilitacyjny IIR Ortopedyczno-Rehabilitacyjny
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Incheon, Republica da Coréia, 400-711
- Inha University Hospital, Medicine/Rheumatology
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Pusan, Republica da Coréia, 602-739
- Pusan National University Hospital, Rheumatology, Internal Medicine
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Ceska Lipa, Tcheca, 470 01
- Revmatologicka ambulance
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Praha 2, Tcheca, 128 50
- Revmatologicky Ustav
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Praha 4, Tcheca, 140 00
- Revmatologicka ambulance
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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 a 99 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Active rheumatoid arthritis
- Incomplete response to methotrexate
Exclusion Criteria:
- Must not be on biologic therapies
- No recent infections
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 |
|---|---|
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Comparador de Placebo: Placebo
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nenhum ingrediente ativo
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Experimental: Ativo
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500 mg po BID
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Percentage of Participants With American College of Rheumatology 20% (ACR20) Response at Week 12
Prazo: Week 12
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ACR20 response: compared to baseline, 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).
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Week 12
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Percentage of Participants With American College of Rheumatology 20% (ACR20) Response at Week 2, 4 and 8
Prazo: Week 2, 4, 8
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ACR20 response: compared to baseline, >=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).
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Week 2, 4, 8
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Percentage of Participants With American College of Rheumatology 50% (ACR50) Response
Prazo: Week 2, 4, 8, 12
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ACR50 response: compared to baseline, >=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).
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Week 2, 4, 8, 12
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Percentage of Participants With American College of Rheumatology 70% (ACR70) Response
Prazo: Week 2, 4, 8, 12
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ACR70 response: compared to baseline, >=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).
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Week 2, 4, 8, 12
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Number of Tender/Painful and Swollen Joints
Prazo: Baseline, Week 2, 4, 8, 12
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Number of tender/painful joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion.
The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.
Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present.
The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.
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Baseline, Week 2, 4, 8, 12
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Physician Global Assessment (PGA) of Arthritis
Prazo: Baseline, Week 2, 4, 8, 12
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Physician global assessment of arthritis was measured on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), with 0 mm= very good and 100 mm= very poor.
This was an evaluation based on the participant's disease signs, functional capacity and physical examination.
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Baseline, Week 2, 4, 8, 12
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Patient's Global Assessment of Arthritis
Prazo: Baseline, Week 2, 4, 8, 12
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Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?"
Participants responded by using a 0 to 100 mm VAS, with 0 mm= very well and 100 mm= very poorly.
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Baseline, Week 2, 4, 8, 12
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Patient's Global Assessment of Arthritic Pain
Prazo: Baseline, Week 2, 4, 8, 12
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Participants measured their pain at the time of assessment on a 0 to 100 mm VAS, with 0 mm= no pain and 100 mm= most severe pain.
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Baseline, Week 2, 4, 8, 12
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Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
Prazo: Baseline, Week 2, 4, 8, 12
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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.
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Baseline, Week 2, 4, 8, 12
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Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP])
Prazo: Baseline, Week 2, 4, 8, 12
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DAS28-3 (CRP) was calculated from the swollen joint count and tender joint count using the 28 joints count and CRP (milligram per liter [mg/L]).
Total score range: 0 to 9.4, higher score indicated more disease activity.
DAS28-3 (CRP) less than or equal to (<=) 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.
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Baseline, Week 2, 4, 8, 12
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C-Reactive Protein (CRP)
Prazo: Baseline, Week 2, 4, 8, 12
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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.
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Baseline, Week 2, 4, 8, 12
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Incidence of Withdrawal Due to Lack of Efficacy
Prazo: Week 2, 4, 8, 12, 14
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Number of participants who withrew due to lack of efficacy were reported.
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Week 2, 4, 8, 12, 14
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Time to Withdrawal Due to Lack of Efficacy
Prazo: Baseline up to Week 14
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Baseline up to Week 14
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
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CE-224,535 Plasma Concentrations
Prazo: 0 hour (pre-dose), 2 hours post-dose at Day 1; 1, 3 hours post-dose at Week 2; 0 hour (pre-dose), 3 hours post-dose at Week 4
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Nominal times were used for summarizing the pharmacokinetic results (0 hours at randomization [Day 1] and Week 4 [pre-dose]; 1 hour at Week 2 [post-dose]; 2 hours at randomization [post-dose on Day 1]; and 3 hours at Week 2 [post-dose] and Week 4 [post-dose]).
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0 hour (pre-dose), 2 hours post-dose at Day 1; 1, 3 hours post-dose at Week 2; 0 hour (pre-dose), 3 hours post-dose at Week 4
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
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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)
7 de abril de 2008
Conclusão Primária (Real)
4 de fevereiro de 2009
Conclusão do estudo (Real)
4 de fevereiro de 2009
Datas de inscrição no estudo
Enviado pela primeira vez
25 de fevereiro de 2008
Enviado pela primeira vez que atendeu aos critérios de CQ
25 de fevereiro de 2008
Primeira postagem (Estimativa)
4 de março de 2008
Atualizações de registro de estudo
Última Atualização Postada (Real)
4 de abril de 2022
Última atualização enviada que atendeu aos critérios de controle de qualidade
9 de março de 2022
Última verificação
1 de março de 2022
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- A6341009
- 2008-000327-25 (Número EudraCT)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
Pfizer will provide access to individual de-identified participant data and related study documents (e.g.
protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.
Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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 .