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This is a multicenter, randomized, double-blind, parallel, placebo-controlled, multiple dose study that will enroll approximately 40 systemic lupus erythematosus subjects with active lupus arthritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG 557 | Drug | AMG 557 will be administered as subcutaneous injections in the anterior abdomen of the subjects. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-emergent adverse events, vital signs, physical examinations, clinical laboratory tests, ECGs, and the incidence of binding and neutralizing antibodies to AMG 557. | 330 days, including a 21-day screening period | |
| Lupus Arthritis Response Rate | 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 | Day 169 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects achieving a) one letter improvement; and b) 'C' or better score in the Musculoskeletal system from BILAG index at Day 169 compared to baseline, by treatment group. | Day 169 | |
| Percentage change in the tender and swollen joint counts at Day 169 relative to baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Los Angeles | California | 90048 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29513931 | Derived | Cheng LE, Amoura Z, Cheah B, Hiepe F, Sullivan BA, Zhou L, Arnold GE, Tsuji WH, Merrill JT, Chung JB. Brief Report: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multiple-Dose Study to Evaluate AMG 557 in Patients With Systemic Lupus Erythematosus and Active Lupus Arthritis. Arthritis Rheumatol. 2018 Jul;70(7):1071-1076. doi: 10.1002/art.40479. Epub 2018 May 25. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000632508 | AMG 557 |
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| Matching Placebo | Drug | Placebo will be administered as subcutaneous injections in the anterior abdomen of the subjects. |
|
| Day 169 |
| Proportion of subjects achieving reduction in and maintenance ≤ 7.5 mg/day of prednisone (or equivalent) from Day 85- Day 169 and discontinuation of immunosuppressants by Day 29 in subjects treated with immunosuppressants at baseline. | Days 85-169 |
| Proportion of subjects achieving reduction in and maintenance of prednisone (or its | Days 85-169 |
| Physician Global Assessment of Disease Activity (PGADA). | 330 days, including a 21-day screening period |
| Subject Global Assessment of Disease Activity (SGADA). | 330 days, including a 21-day screening period |
| Serum PK profile of AMG 557 after multiple dose administrations. | 330 days, including a 21-day screening period |
| Proportion of subjects who discontinued immunosuppressants by Day 29 in subjects | Day 29 |
| Cumulative dose of prednisone (or its equivalent) from Day 85 to Day 169. | Day 85 to Day 169 |
| San Leandro |
| California |
| 94578 |
| United States |
| Research Site | Danbury | Connecticut | 06810 | United States |
| Research Site | Manhasset | New York | 11030 | United States |
| Research Site | St Leonards | New South Wales | 2065 | Australia |
| Research Site | Odense | 5000 | Denmark |
| Research Site | Lille | 59037 | France |
| Research Site | Berlin | 10117 | Germany |
| Research Site | Kuala Lumpur | Kuala Lumpur | 59100 | Malaysia |
| Research Site | Kuching | Sarawak | 93586 | Malaysia |
| Research Site | Taipei | 10002 | Taiwan |
| Research Site | Birmingham | B18 7QH | United Kingdom |
| Research Site | London | WC1E 6JF | United Kingdom |