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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)
Completed
NCT02983227 2016-000498-19 GA30067
The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.
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.
Researchers wanted to find out what effect, good or bad, fenebrutinib caused in patients with rheumatoid arthritis (RA) who received long-term treatment. This was an “open-label extension” study. Open-label meant that patients and researchers knew what treatment the patients were getting. It was an “extension study” because RA patients were required to have previously participated in another study that investigated fenebrutinib (and placebo) for RA disease.