NCT02983227

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 496 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years – 76 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	GDC-0853	GDC-0853 was administered orally at a dose of 200mg, as per the dosing schedules described above.

Timeline

• Start date: 2016-11-30
• Primary completion: 2019-07-17
• Completion: 2019-07-17
• First posted: 2016-12-06
• Last updated: 2020-08-03
• Results posted: 2020-08-03

Locations

104 sites across 10 countries: United States, Argentina, Brazil, Bulgaria, Colombia, Mexico, Poland, Russia, Serbia, Ukraine

Regulatory

• FDA-regulated drug study