Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA)
Summary
This is a multicenter, Phase II, randomized, double-blind, placebo-controlled, active comparator (Cohort 1 only), parallel-group, dose-ranging study to evaluate the efficacy and safety of GDC-0853 in participants with moderate to severe active RA and an inadequate response to previous methotrexate (MTX) therapy (Cohort 1) or MTX and tumor necrosis factor (TNF) therapy who may have also had exposure to no more than one non-TNF inhibitor biologic (Cohort 2).
Timeline
- Start
- 2016-09-09
- Primary completion
- 2018-07-02
- Completion
- 2018-07-02
Outcome
Met primary endpoint
registry analysis (superiority test); Cohort 1: GDC-0853 Mid Dose + Adalimumab Placebo vs Cohort 1: GDC-0853 Placebo + Adalimumab Placebo; p = 0.0164; Weighted difference 12.93 (95% CI 2.37 to 23.48); NCT02833350 ↗
registry analysis (superiority test); Cohort 1: GDC-0853 High Dose + Adalimumab Placebo vs Cohort 1: GDC-0853 Placebo + Adalimumab Placebo; p = 0.0003; Weighted difference 20.00 (95% CI 9.21 to 30.79); NCT02833350 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Adalimumab | Monoclonal antibody | — | Subcutaneous |
| Subject | Fenebrutinib | Small molecule | — | Oral |
| Background | Methotrexate | Small molecule | 15 mg | Oral |
| Background | Methotrexate | Small molecule | 25 mg | Oral |
| Background | folic acid | Other / unclassified | 5 mg | — |