CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 496 enrolled
Drug / intervention
GDC-0853drug
Likely dose
GDC-0853 200mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02983227
NCT02983227Phase 2Completed
CompareCT.gov

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

Genentech, Inc.·interventional·Posted Dec 6, 2016·Updated Aug 3, 2020

In Brief

A Phase 2 clinical trial evaluating GDC-0853 for Rheumatoid Arthritis. Completed, enrolled 496 participants across 104 sites in 10 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesArgentina, Brazil, Bulgaria, Colombia, Mexico, Poland, Russia, Serbia, Ukraine, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedDec 6, 2016
Enrollment StartNov 30, 2016
Primary CompletionJul 17, 2019
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 9.6 years ago

Interventions

GDC-0853drug

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