Lupus Arthritis, Systemic Lupus Erythematosus
Conditions
Keywords
Lupus Arthritis, Systemic Lupus Erythematosus, AMG 557, Lupus
Brief summary
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.
Interventions
DRUGAMG 557
AMG 557 will be administered as subcutaneous injections in the anterior abdomen of the subjects.
DRUGMatching Placebo
Placebo will be administered as subcutaneous injections in the anterior abdomen of the subjects.
Sponsors
Amgen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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) ≥ 6 at screening; * Other inclusion criteria may apply.
Exclusion criteria
* Presence or history of vasculitis, and presence or history of active lupus nephritis requiring therapy within the last 3 years * Any disorder (including psychiatric), condition, clinically significant disease, disease activity related to SLE * Positive for HIV antibodies, hepatitis B surface antigen or anti-HBc, or hepatitis C antibodies * Known residential exposure to an individual with tuberculosis or positive Quantiferon test or PPD test at screening * Men and women of reproductive potential, unwilling to practice a highly effective method of birth control for the duration of the study * Other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Day 169 | 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| 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 |
| Subject Global Assessment of Disease Activity (SGADA). | 330 days, including a 21-day screening period |
| Percentage change in the tender and swollen joint counts at Day 169 relative to baseline. | Day 169 |
Countries
Australia, Denmark, France, Germany, Malaysia, Taiwan, United Kingdom, United States
Outcome results
None listed