Lupus Arthritis, Systemic Lupus Erythematosus Clinical Trial
Official title:
A Randomized, Double-blind, Parallel, Placebo-controlled, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Effect of AMG 557 in Systemic Lupus Erythematosus (SLE) Subjects With Active Lupus Arthritis
| Verified date | January 2017 |
| Source | Amgen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | March 2016 |
| Est. primary completion date | March 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
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 exclusion criteria may apply |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Research Site | St Leonards | New South Wales |
| Denmark | Research Site | Odense | |
| France | Research Site | Lille cedex 01 | |
| Germany | Research Site | Berlin | |
| Malaysia | Research Site | Kuala Lumpur | Wilayah Persekutuan |
| Malaysia | Research Site | Kuching | Sarawak |
| Taiwan | Research Site | Taipei | |
| United Kingdom | Research Site | Birmingham | |
| United Kingdom | Research Site | London | |
| United States | Research Site | Danbury | Connecticut |
| United States | Research Site | Los Angeles | California |
| United States | Research Site | Manhasset | New York |
| United States | Research Site | San Leandro | California |
| Lead Sponsor | Collaborator |
|---|---|
| Amgen |
United States, Australia, Denmark, France, Germany, Malaysia, Taiwan, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | ||
| Primary | 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 | |
| Secondary | 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 | ||
| Secondary | Percentage change in the tender and swollen joint counts at Day 169 relative to baseline. | Day 169 | ||
| Secondary | 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 | ||
| Secondary | Proportion of subjects achieving reduction in and maintenance of prednisone (or its | Days 85-169 | ||
| Secondary | Physician Global Assessment of Disease Activity (PGADA). | 330 days, including a 21-day screening period | ||
| Secondary | Subject Global Assessment of Disease Activity (SGADA). | 330 days, including a 21-day screening period | ||
| Secondary | Serum PK profile of AMG 557 after multiple dose administrations. | 330 days, including a 21-day screening period | ||
| Secondary | Proportion of subjects who discontinued immunosuppressants by Day 29 in subjects | Day 29 | ||
| Secondary | Cumulative dose of prednisone (or its equivalent) from Day 85 to Day 169. | Day 85 to Day 169 |