Safety Study of AMG 557 in Subjects With Lupus Arthritis
Status: | Completed |
---|---|
Conditions: | Arthritis, Lupus |
Therapuetic Areas: | Immunology / Infectious Diseases, Rheumatology |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 4/22/2016 |
Start Date: | June 2012 |
End Date: | April 2016 |
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
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.
study that will enroll approximately 40 systemic lupus erythematosus subjects with active
lupus arthritis.
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
We found this trial at
5
sites
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