Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02885181 | Safety, Tolerability, and Efficacy of GS-9876 in Participants With Active Rheumatoid Arthritis on Background Therapy With Methotrexate | PHASE2 | COMPLETED | 83 | — | — | Sep 21, 2016 | Sep 20, 2017 | Sep 19, 2018 | 19 | United States, Bulgaria +5 |
Disease Activity Score 28 C-Reactive Protein (DAS28 (CRP)) is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), participant's global assessment of disease activity (visual analog scale: 0 = no disease activity to 100 = maximum disease activity) and C-Reactive Protein (CRP) for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. A negative change from baseline indicates improvement.
| Arm | Type | Description |
|---|---|---|
| GS-9876 - 30 mg | EXPERIMENTAL | GS-9876 30 mg + filgotinib placebo for 12 weeks |
| GS-9876 - 10 mg | EXPERIMENTAL | GS-9876 10 mg + filgotinib placebo for 12 weeks |
| Filgotinib | EXPERIMENTAL | Filgotinib + GS-9876 placebo for 12 weeks |
| Placebo | PLACEBO_COMPARATOR | GS-9876 placebo + filgotinib placebo for 12 weeks |
| Name | Type | Description |
|---|---|---|
| GS-9876 | DRUG | One tablet administered orally once daily |
| Filgotinib | DRUG | Two tablets administered orally once daily |
| GS-9876 placebo | DRUG | One tablet administered orally once daily |
| Filgotinib placebo | DRUG | Two tablets administered orally once daily |
| Methotrexate | DRUG | Background therapy with methotrexate administered orally or parenterally once weekly |
Key Inclusion Criteria: * Active RA disease as defined by: a tender joint count (TJC) of ≥ 6 (out of 68), a swollen joint count (SJC) of ≥ 6 (out of 66) at screening and Day 1 * Inadequate response to treatment with oral or parenteral methotrexate (MTX) 7.5 to 25 mg/week continuously for at least 1...