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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04634253 | A Study of LY3462817 in Participants With Rheumatoid Arthritis | PHASE2 | COMPLETED | 98 | — | — | Jan 4, 2021 | Jun 29, 2022 | Jul 12, 2023 | 26 | United States, Czechia +5 |
Disease Activity Score (DAS) based on a 28 joint count hsCRP consisted of composite numerical score of the following variables: tender joint count (TJC28), swollen joint count (SJC28), hsCRP (mg/mL), and participant's global assessment of disease activity. DAS28-hsCRP was calculated using following formula: DAS28-hsCRP equals to (=) 0.56\*square root (sqrt) (TJC28) plus (+) 0.28\*sqrt (SJC28)+ 0.014\* participant's global assessment of disease activity + 0.36\*natural log(hsCRP+1) +0.96. Scores ranged 1.0-9.4, where lower scores indicated less disease activity. Least Square Mean (LS Mean) was calculated using mixed model repeated measures (MMRM) with treatment, strata (previous RA therapy population), baseline value, visit, treatment-by-visit interaction as fixed factors.
| Arm | Type | Description |
|---|---|---|
| LY3462817 300 mg | EXPERIMENTAL | Participants received Intravenous (IV) infusion of 300 mg LY3462817 solution. |
| LY3462817 700 mg | EXPERIMENTAL | Participants received IV infusion of 700 mg LY3462817 solution. |
| Placebo | PLACEBO_COMPARATOR | Participants received IV infusion of 0.9% sodium chloride solution (Placebo). |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Given IV |
| LY3462817 | DRUG | Given IV |
Inclusion Criteria: * Have a diagnosis of adult onset RA as defined by the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for at least 3 months prior to screening * Have moderately to severely active RA defined by the presence of ≥6 sw...