A Study of Tabalumab (LY2127399) Using Two Different Injection Methods in Participants With Lupus
NCT ID: NCT02041091
Last Updated: 2018-06-15
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
226 participants
INTERVENTIONAL
2014-01-31
2015-11-30
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
NONE
Study Groups
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Tabalumab Auto-Injector
Tabalumab given Week 0 as a loading dose of 240 milligram (mg) given as two subcutaneous (SC) injections each of 120 mg followed by 120 mg SC injection every two weeks for 12 weeks. Participants may continue on this treatment regimen for 52 weeks.
Tabalumab Auto-Injector
Administered SC
Tabalumab Prefilled Syringe
Tabalumab given Week 0 as a loading dose of 240 mg given as two SC injections each of 120 mg followed by 120 mg SC injections every two weeks for 12 weeks. Participants may continue to on this treatment regimen for 52 weeks.
Tabalumab Prefilled Syringe
Administered SC
Interventions
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Tabalumab Auto-Injector
Administered SC
Tabalumab Prefilled Syringe
Administered SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able and willing to have blood drawn for PK sampling.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Medvin Clinical Research
Covina, California, United States
TriWest Research Associates
El Cajon, California, United States
ProHealth Partners Medical Group
Long Beach, California, United States
Wallace Rheumatic Study Center
Los Angeles, California, United States
Desert Medical Advances
Palm Desert, California, United States
Inlande Rheumatology Clinical Trials
Upland, California, United States
Denver Arthritis Center
Denver, Colorado, United States
New England Research Associates
Trumbull, Connecticut, United States
Advanced Pharma Clinical Research
Miami, Florida, United States
New Horizon Research Center
Miami, Florida, United States
Arthritis Research of Florida
Palm Harbor, Florida, United States
Clinical Research of West Florida, Inc.
Tampa, Florida, United States
Indiana University Health
Indianapolis, Indiana, United States
The Arthritis & Diabetes Clinic Inc.
Monroe, Louisiana, United States
West Michigan Rheumatology
Grand Rapids, Michigan, United States
Clayton Medical Research
St Louis, Missouri, United States
Physician Research Collaboration, LLC
Lincoln, Nebraska, United States
Westroads Clinical Research-Omaha
Omaha, Nebraska, United States
Innovative Health Research
Las Vegas, Nevada, United States
(AOA) Arthritis & Osteoporosis Associates
Freehold, New Jersey, United States
Albuquerque Clinical Trials
Albuquerque, New Mexico, United States
The Feinstein Institute for Medical Research
Manhasset, New York, United States
Box Arthritis & Rheumatology of the Carolinas, PLLC
Charlotte, North Carolina, United States
PharmQuest
Greensboro, North Carolina, United States
Shanahan Rheumatology & Immunotherapy
Raleigh, North Carolina, United States
PMG Research of Salisbury
Salisbury, North Carolina, United States
Paramount Medical Research
Middleburg Heights, Ohio, United States
Oklahoma Arthritis Center
Edmond, Oklahoma, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Clinical Research Center of Reading, LLP
Wyomissing, Pennsylvania, United States
Low Country Research Center
North Charleston, South Carolina, United States
Tekton Research, Inc.
Austin, Texas, United States
Sun Research Institute
San Antonio, Texas, United States
Virginia Clinical Research
Norfolk, Virginia, United States
Arthritis Northwest Rheumatology
Spokane, Washington, United States
Mountain State Clinical Research
Clarksburg, West Virginia, United States
Office: Perez de Jesus, Amarylis
Caguas, , Puerto Rico
Ramon L. Ortega Colon
Carolina, , Puerto Rico
GCM Medical Group PSC
San Juan, , Puerto Rico
Mindful Medical Research
San Juan, , Puerto Rico
Latin Clinical Trial Center
Santurce, , Puerto Rico
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Daejeon, , South Korea
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Incheon, , South Korea
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Seoul, , South Korea
Countries
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Other Identifiers
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H9B-MC-BCEI
Identifier Type: OTHER
Identifier Source: secondary_id
15193
Identifier Type: -
Identifier Source: org_study_id
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