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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02041091 |
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Date of registration:
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17/01/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study of Tabalumab (LY2127399) Using Two Different Injection Methods in Participants With Lupus
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Scientific title:
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Pharmacokinetic Evaluations of Tabalumab Following Subcutaneous Administration by Prefilled Syringe or Auto Injector in Patients With Systemic Lupus Erythematosus |
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Date of first enrolment:
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January 2014 |
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Target sample size:
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226 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02041091 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Korea, Republic of
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Mexico
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Puerto Rico
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United States
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Contacts
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Name:
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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) |
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Address:
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Telephone:
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Email:
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Affiliation:
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Eli Lilly and Company |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Lupus Erythematosus, Systemic
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Intervention(s)
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Drug: Tabalumab Prefilled Syringe
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Drug: Tabalumab Auto-Injector
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Primary Outcome(s)
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Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time 0 to 14 Days (AUC 0-14) of Tabalumab After Loading Dose
[Time Frame: Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab]
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Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tabalumab After Loading Dose
[Time Frame: Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab]
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Secondary Outcome(s)
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Pharmacokinetics (PK): AUC 0-14 of Tabalumab Based on Injection Site Stratifications
[Time Frame: Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab]
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Pharmacokinetics (PK): AUC 0-14 of Tabalumab Based on Body Weight
[Time Frame: Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab]
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Pharmacokinetics (PK): Cmax of Tabalumab Based on Injection Site Stratifications
[Time Frame: Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab]
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Number of Participants Reporting Incomplete Tabalumab Dose Administration
[Time Frame: Week 0 through Week 12]
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Pharmacokinetics (PK): Cmax of Tabalumab Based on Body Weight
[Time Frame: Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab]
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Number of Participants Developing Anti-Tabalumab Antibodies
[Time Frame: Week 0 through Week 12]
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Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score
[Time Frame: Week 0, Week 4 and Week 8]
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Secondary ID(s)
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15193
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H9B-MC-BCEI
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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