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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genentech, Inc.
Age
18–76
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | 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
