Safety Study of AMG 557 in Subjects With Lupus Arthritis

Completed · Phase 1 · Has a placebo group

Conditions studied: Lupus Arthritis, Systemic Lupus Erythematosus

In brief

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.

Key facts

Study ID

NCT01683695

Run by

Amgen

People needed

20

Starts

2012-06-01

Expected to finish

2016-03-01

Last updated by the study team

2017-01-24

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Research Site — Los Angeles, California, United States
• Research Site — San Leandro, California, United States
• Research Site — Danbury, Connecticut, United States
• Research Site — Manhasset, New York, United States
• Research Site — St Leonards, New South Wales, Australia
• Research Site — Odense, Denmark
• Research Site — Lille, France
• Research Site — Berlin, Germany
• Research Site — Kuala Lumpur, Kuala Lumpur, Malaysia
• Research Site — Kuching, Sarawak, Malaysia
• Research Site — Taipei, Taiwan
• Research Site — Birmingham, United Kingdom
• Research Site — London, United Kingdom

Full record on ClinicalTrials.gov

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