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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01683695 | Safety Study of AMG 557 in Subjects With Lupus Arthritis | PHASE1 | COMPLETED | 20 | — | — | Jun 1, 2012 | Mar 1, 2016 | Jan 24, 2017 | 13 | United States, Australia +6 |
Defined by: 1) achieving at least a 50% decrease in the combined tender and swollen joint count compared to baseline at Day 169; 2) achieving one letter improvement in the Musculoskeletal System BILAG at Day 169 compared to baseline; 3) reduction in and maintenance of prednisone (or its equivalent) dose to ≤ 50% of baseline corticosteroid dose (Day 1 predose) or ≤ 7.5 mg/day, whichever is lower, from Day 85 to Day 169 in subjects not treated with immunosuppressants at baseline, or reduction in and maintenance of prednisone (or its equivalent) dose to ≤ 7.5 mg/day from Day 85 to Day 169 and discontinuation of immunosuppressants by Day 29 in subjects treated with immunosuppressants at baseline
| Arm | Type | Description |
|---|---|---|
| AMG 557 | ACTIVE_COMPARATOR | All will receive AMG 557 on Day 1, Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, Day 113, Day 127, Day 141 and Day 155. |
| AMG 557 Matching Placebo | PLACEBO_COMPARATOR | All will receive AMG 557 on Day 1, Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, Day 113, Day 127, Day 141 and Day 155. |
| Name | Type | Description |
|---|---|---|
| AMG 557 | DRUG | AMG 557 will be administered as subcutaneous injections in the anterior abdomen of the subjects. |
| Matching Placebo | DRUG | Placebo will be administered as subcutaneous injections in the anterior abdomen of the subjects. |
Inclusion Criteria: * Diagnosis of SLE for at least 6 months as defined by the most recent American College of Rheumatology criteria * Presence of lupus related inflammatory arthritis with at least four tender and four swollen joints; and Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)...