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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00674635 | Phase II Study Evaluating the Safety and Efficacy of GSK315234A in Patients With Rheumatoid Arthritis | PHASE2 | COMPLETED | 135 | — | — | Apr 1, 2008 | Dec 1, 2010 | Dec 1, 2016 | 19 | Australia, New Zealand +3 |
safety assessment includes AEs, vital signs, ECG, clinical laboratory tests.
DAS28 at Day 28 and DAS28 at Day 56
DAS28 scores on Day 56 (Part B and C)
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | matching placebo |
| GSK315234A | ACTIVE_COMPARATOR | Part A single IV dose; Part B 3 repeat IV dose at Day 1, Day 28 and Day 56; Part C single SC dose |
| Name | Type | Description |
|---|---|---|
| GSK3152314A | DRUG | Part A single IV dose; Part B 3 repeat IV dose at Day 1, Day 28 and Day 56; Part C single SC dose |
| Placebo | DRUG | matching placebo |
Inclusion Criteria: * Males or females between 18 and 75 years of age, inclusive. * All subjects must use acceptable contraception (as defined in the study restriction section) to ensure that no pregnancies occur during the course of the study and for at least 12 weeks after dosing for males and fo...