Safety Study of AMG 557 in Subjects With Lupus Arthritis
NCT ID: NCT01683695
Last Updated: 2017-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2012-06-30
2016-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AMG 557
All will receive AMG 557 on Day 1, Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, Day 113, Day 127, Day 141 and Day 155.
AMG 557
AMG 557 will be administered as subcutaneous injections in the anterior abdomen of the subjects.
AMG 557 Matching Placebo
All will receive AMG 557 on Day 1, Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, Day 113, Day 127, Day 141 and Day 155.
Matching Placebo
Placebo will be administered as subcutaneous injections in the anterior abdomen of the subjects.
Interventions
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AMG 557
AMG 557 will be administered as subcutaneous injections in the anterior abdomen of the subjects.
Matching Placebo
Placebo will be administered as subcutaneous injections in the anterior abdomen of the subjects.
Eligibility Criteria
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Inclusion 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;
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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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
Countries
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References
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Cheng LE, Amoura Z, Cheah B, Hiepe F, Sullivan BA, Zhou L, Arnold GE, Tsuji WH, Merrill JT, Chung JB. Brief Report: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multiple-Dose Study to Evaluate AMG 557 in Patients With Systemic Lupus Erythematosus and Active Lupus Arthritis. Arthritis Rheumatol. 2018 Jul;70(7):1071-1076. doi: 10.1002/art.40479. Epub 2018 May 25.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20101103
Identifier Type: -
Identifier Source: org_study_id
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