A Study of Tabalumab (LY2127399) Using Two Different Injection Methods in Participants With Lupus



Status:Terminated
Conditions:Lupus
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:6/17/2018
Start Date:January 2014
End Date:November 2015

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Pharmacokinetic Evaluations of Tabalumab Following Subcutaneous Administration by Prefilled Syringe or Auto Injector in Patients With Systemic Lupus Erythematosus

The purpose of this study is to evaluate the amount of tabalumab in the blood after it is
given by two different injection methods - A traditional syringe or a spring loaded syringe
for 12 weeks. Participants may continue to receive study drug for up to 52 weeks.


Inclusion Criteria:

- Diagnosis of Lupus.

- Able and willing to have blood drawn for PK sampling.

Exclusion Criteria:

- Have severe active lupus nephritis.

- Have severe active central nervous system (CNS) or peripheral neurologic disease or
other severe neurologic involvement requiring treatment within approximately 3 months
prior to screening.

- Have received high dose corticosteroid within approximately 1 month prior to baseline.

- Have initiated or adjusted treatment with immunosuppressant drugs within approximately
1 month prior to baseline.

- Have received plasmapheresis within approximately 3 months prior to baseline.

- Have previously received approved or experimental B cell targeted therapies within the
last year.

- Have received any biologic or non-biologic therapy within approximately 3 months or 5
half-lives (whichever is longer).

- Have a history of severe reaction to any biologic therapy.

- Have an active or recent infection within approximately 1 month prior to Week 0.

- Have had a serious infection within approximately 3 month or serious bone/joint
infection within approximately 6 months prior to baseline.

- Have evidence of or test positive for active hepatitis B or are positive for hepatitis
C or human immunodeficiency virus (HIV).

- Have evidence of active or latent tuberculosis.

- Have significant hematological abnormalities.
We found this trial at
37
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Albuquerque, New Mexico
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Austin, Texas 78745
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Charlotte, North Carolina 00000
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Clarksburg, West Virginia 26301
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Covina, California 91723
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Daejeon,
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Denver, Colorado 80230
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Duncansville, Pennsylvania 16635
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Edmond, Oklahoma 73013
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El Cajon, California 92020
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Freehold, New Jersey 07728
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Grand Rapids, Michigan 49546
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Greensboro, North Carolina 27408
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Indianapolis, Indiana 46202
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Las Vegas, Nevada 89128
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Lincoln, Nebraska 68512
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Long Beach, California 90808
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Los Angeles, California 90048
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Manhasset, NY
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Miami, Florida 33175
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Miami, Florida 33175
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Middleburg Heights, Ohio 44130
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Monroe, Louisiana 71203
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Norfolk, Virginia 23507
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North Charleston, South Carolina 29406
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Omaha, Nebraska 68114
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Palm Desert, California 92260
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Palm Harbor, Florida 34684
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Raleigh, North Carolina 27617
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Saint Louis, Missouri 63117
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Salisbury, North Carolina 28144
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San Antonio, Texas 78215
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Spokane, Washington 99204
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5115 North Armenia Avenue
Tampa, Florida 33603
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Trumbull, Connecticut 06611
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Upland, California 91786
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Wyomissing, Pennsylvania 19610
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