Select Your Region
Global
Encontre os centros médicos participantes e o status atual do estudo em cada um deles
Encontrar centros médicos participantes
-
Início
-
Localizador de ensaios clínicos
- Detalhes do ensaio clínico
Um estudo dos efeitos a longo prazo do tratamento com fenebrutinibe em pacientes com artrite reumatoide
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
Sponsor
Genentech, Inc.
Phase
Fase 2
Study Identifier
NCT02983227, GA30067, 2016-000498-19
Condition
Rheumatoid Arthritis
Official Title
A Phase II Open-Label Extension Study of Patients Previously Enrolled in Study GA29350 to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Patients With Moderate to Severe Rheumatoid Arthritis
Study Summary
A study to evaluate the long-term safety and efficacy of GDC-0853 in participants with moderate to severe active Rheumatoid Arthritis (RA) who have completed 12 weeks of study treatment in Study GA29350. Eligible participants from Study GA29350 who elect to participate will receive treatment with GDC-0853 twice daily (BID) in an open-label fashion for 52 weeks, followed by a safety follow-up period of 8 weeks.
Eligibility Criteria
All
≥ 18 Years & ≤ 76 Years
No
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Esta página resume informações de sites de registro público, como ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com etc. Para saber mais sobre este estudo, consulte a guia Para profissionais médicos ou visite um desses sites.
As informações abaixo foram obtidas diretamente de sites de registro público, como ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com etc., e não foram editadas.
Results Disclaimer
Explore estudos relacionados
For the latest version of this information please go to www.forpatients.roche.com
Compartilhar este estudo
Link to PageUsando uma destas opções
Copiado para a área de transferência!