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
sites
San Antonio, Texas 78215
1786
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from 98109
San Antonio, TX
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Albuquerque, New Mexico
1184
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Albuquerque, NM
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Austin, Texas 78745
1770
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Austin, TX
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Charlotte, North Carolina 00000
2281
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Charlotte, NC
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Clarksburg, West Virginia 26301
2155
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Clarksburg, WV
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Covina, California 91723
964
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Covina, CA
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Daejeon,
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Denver, Colorado 80230
1025
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Denver, CO
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Duncansville, Pennsylvania 16635
2206
mi
from 98109
Duncansville, PA
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Edmond, Oklahoma 73013
1516
mi
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Edmond, OK
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El Cajon, California 92020
1062
mi
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El Cajon, CA
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Freehold, New Jersey 07728
2404
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from 98109
Freehold, NJ
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Grand Rapids, Michigan 49546
1802
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from 98109
Grand Rapids, MI
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Greensboro, North Carolina 27408
2295
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Greensboro, NC
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Indianapolis, Indiana 46202
1868
mi
from 98109
Indianapolis, IN
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Las Vegas, Nevada 89128
868
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from 98109
Las Vegas, NV
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Lincoln, Nebraska 68512
1346
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from 98109
Lincoln, NE
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Long Beach, California 90808
979
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Long Beach, CA
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Los Angeles, California 90048
959
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Los Angeles, CA
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2413
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Manhasset, NY
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Miami, Florida 33175
2724
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Miami, FL
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Miami, Florida 33175
2732
mi
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Miami, FL
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Middleburg Heights, Ohio 44130
2019
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Middleburg Heights, OH
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Monroe, Louisiana 71203
1891
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Monroe, LA
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Norfolk, Virginia 23507
2429
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Norfolk, VA
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North Charleston, South Carolina 29406
2412
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North Charleston, SC
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Omaha, Nebraska 68114
1366
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Omaha, NE
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Palm Desert, California 92260
1010
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Palm Desert, CA
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Palm Harbor, Florida 34684
2508
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Palm Harbor, FL
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Raleigh, North Carolina 27617
2361
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Raleigh, NC
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Saint Louis, Missouri 63117
1714
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Saint Louis, MO
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Salisbury, North Carolina 28144
2281
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Salisbury, NC
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Spokane, Washington 99204
228
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Spokane, WA
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5115 North Armenia Avenue
Tampa, Florida 33603
2523
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Tampa, FL
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Trumbull, Connecticut 06611
2421
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Trumbull, CT
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Upland, California 91786
965
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Upland, CA
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Wyomissing, Pennsylvania 19610
2323
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Wyomissing, PA
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