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A study of long-term effects of fenebrutinib treatment in patients with rheumatoid arthritis
A Study to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Participants With Moderate to Severe Rheumatoid Arthritis Enrolled in Study GA29350 (NCT02833350)
Transtorno Autoimune Artrite Reumatoide
Detalhes básicos
Patrocinador
Genentech, Inc.
Fase
Fase 2
Identificador de estudo
NCT02983227, GA30067, 2016-000498-19
Condição
Artrite Reumatoide
Título
Estudo aberto de extensão de fase II de participantes anteriormente incluídos no estudo GA29350 para avaliar a segurança e a eficácia de longo prazo do GDC-0853 em participantes com Artrite Reumatoide de moderada a grave.
Resumo do Estudo
Este é um estudo de fase II, multicêntrico, OLE para avaliar a segurança e a eficácia de longo prazo do GDC-0853 em participantes com AR que concluíram doze semanas de tratamento no estudo GA29350. A população para este estudo consiste em participantes com AR que apresentaram resposta inadequada à terapia anterior com Metotrexato (MTX) (coorte 1 do estudo GA29350) ou terapia anterior com TNF e MTX (coorte 2 do estudo GA29350).
Critérios de elegibilidade
Todos
≥ 18 Anos & ≤ 76 Anos
Não
Critérios de Inclusão
- Completion of treatment as specified in Study GA29350, including completion of the Day 84 study visit assessments
- Acceptable safety and tolerability during Study GA29350 as determined by the investigator or Medical Monitor
- Have not received any prohibited medications in Study GA29350
- While taking methotrexate, must be willing to receive oral folic acid (at least 5 milligrams per week [mg/week])
- If receiving oral corticosteroids (less than or equal to [</=] 10 milligrams per day [mg/day] prednisone or equivalent) and/or non-steroidal anti-inflammatory drugs, doses have remained stable for the duration of Study GA29350
Critérios de Exclusão
- Met protocol defined treatment stopping criteria during Study GA29350
- Treatment with any investigational agent (i.e., other than study drug) or live/attenuated vaccine or any other prohibited medication during Study GA29350 or since the last administration of study drug in Study GA29350
- In the opinion of the investigator, any new (since initially enrolling in the Phase II Study GA29350), significant, uncontrolled comorbidity that would increase the risk to the participant in Study GA30067
- Pregnant or lactating, or intending to become pregnant during the study
- Participants who experienced a de novo or reactivated serious viral infection such as hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) during the Phase II Study GA29350
- Any major episode of infection requiring hospitalization or treatment with intravenous antibiotics during the Phase II Study GA29350
- Participants who developed a malignancy during the Phase II Study GA29350
- 12-lead electrocardiogram (ECG) on Day 84 in Study GA29350 that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results
- Current treatment with medications that are well known to prolong the QT interval
A seguinte informação vem do site ClinicalTrials.gov publicamente disponível e foi editada para leigos.
As informações abaixo se origina a partir do site ClinicalTrials.gov publicamente disponível e não foi modificado.
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