Resumen

Estudio para evaluar la seguridad y eficacia a largo plazo de GDC-0853 en participantes con artritis reumatoide (AR) activa moderada a grave que completaron 12 semanas de tratamiento en el estudio GA29350. Los participantes elegibles del estudio GA29350 que elijan participar recibirán tratamiento con GDC-0853 dos veces al día (BID) de forma abierta durante 52 semanas, seguido de un período de seguimiento de seguridad de 8 semanas.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 76 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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
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

Ubicaciones

Instituto de Investigaciones Clinicas-Mar del Plata

Buenos Aires, Argentina

APRILLUS

Buenos Aires, Argentina

Instituto centenario

Buenos Aires, Argentina

Centro de Investigacion en Enfermedades Reumaticas CIER

Ciudad Autonoma Buenos Aires, Argentina

Expertia S.A- Mautalen Salud e Investigación

Ciudad Autonoma Buenos Aires, Argentina

CCBR - Buenos Aires - AR; AxisMed SRL

Ciudad Autonoma Buenos Aires, Argentina

ILAIM-CEOM Inst. Latinoamericano de Inv. Medicas

Córdoba, Argentina

Centro de Investigaciones Medicas Mar Del Plata

Mar del Plata, Argentina

Instituto de Investigaciones Clinicas

Rosario, Argentina

CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica

San Juan, Argentina

Centro Medico Privado de Reumatologia; Reumathology

San Miguel, Argentina

Estudio de extensión abierto de fase II en pacientes previamente incluidos en el estudio GA29350 para evaluar la seguridad y eficacia a largo plazo de GDC-0853 en pacientes con artritis reumatoide moderada a grave

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

GDC-0853

Ubicaciones

Instituto de Investigaciones Clinicas-Mar del Plata

APRILLUS

Instituto centenario

Centro de Investigacion en Enfermedades Reumaticas CIER

Expertia S.A- Mautalen Salud e Investigación

CCBR - Buenos Aires - AR; AxisMed SRL

ILAIM-CEOM Inst. Latinoamericano de Inv. Medicas

Centro de Investigaciones Medicas Mar Del Plata

Instituto de Investigaciones Clinicas

CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica

Centro Medico Privado de Reumatologia; Reumathology

Patrocinadores