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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02683785 | A Study to Investigate the Efficacy and Safety of GSK3196165 in Inflammatory Hand Osteoarthritis | PHASE2 | COMPLETED | 44 | — | — | Mar 17, 2016 | Nov 29, 2017 | Jan 11, 2021 | 16 | United States, Germany +3 |
Participants were required to complete a daily pain NRS based on their 24-hour average hand pain intensity with the anchors "0" (no pain) and "10" (worst imaginable pain), which was averaged over the 7 days prior to assessment visit. The 7 day average score was calculated as sum of daily 24 hours average hand pain NRS scores in the 7 days prior to assessment visit, divided by number of entries recorded in those 7 days. Baseline visit was at Day 1 and Baseline value was defined as the average of the 7 days prior to baseline visit (Day 1 pre-dose). Change from Baseline is equal to post-dose visit value minus Baseline value. Intent-To-Treat Population comprised of all randomized participants who received at least one dose of study treatment (GSK3196165 or placebo).
| Arm | Type | Description |
|---|---|---|
| GSK3196165 | EXPERIMENTAL | Subjects will receive a total of 8 doses of GSK3196165 over a 12-week treatment period. |
| Placebo | PLACEBO_COMPARATOR | Subjects will receive a total of 8 doses of placebo over a 12-week treatment period. |
| Name | Type | Description |
|---|---|---|
| GSK3196165 | DRUG | GSK3196165 will be supplied as a liquid and will be administered as a subcutaneous injection. The drug will be administered weekly for 5 injections, then every other week for 3 further injections. |
| Placebo | DRUG | Matching placebo will be administered as above. |
Inclusion Criteria: * Age \>=18 years at the time of signing informed consent. * Meets American College of Rheumatology (ACR) classification of osteoarthritis (OA) and have not responded to analgesics (level 1 and 2) or to non-steroidal anti-inflammatory drugs (NSAIDs) for at least 10 days in the p...