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

Use our guide to learn which trials are right for you!

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.


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
?
mi
from
Manhasset, NY
Click here to add this to my saved trials
?
mi
from
Danbury, CT
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
San Leandro, CA
Click here to add this to my saved trials
St Leonards, New South Wales 2065
?
mi
from
St Leonards,
Click here to add this to my saved trials