Pharmacokinetic Evaluations of Tabalumab Following Subcutaneous Administration by Prefilled Syringe or Auto Injector in Patients With Systemic Lupus Erythematosus
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 226
- 试验地点
- 42
- 主要终点
- Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time 0 to 14 Days (AUC 0-14) of Tabalumab After Loading Dose
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Lupus.
- •Able and willing to have blood drawn for PK sampling.
排除标准
- •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
- •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.
研究组 & 干预措施
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.
干预措施: Tabalumab Auto-Injector (Drug)
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.
干预措施: Tabalumab Prefilled Syringe (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time 0 to 14 Days (AUC 0-14) of Tabalumab After Loading Dose
时间窗: Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab
Area under the concentration time curve after the loading dose, assessed over the 14-day dosing interval, stratified by device.PK samples taken during the first dosing interval, days 4, 7, 9, 11, 14, were analyzed using NCA methods to calculate the geometric mean.
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tabalumab After Loading Dose
时间窗: Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab
Maximum serum concentration of tabalumab, after the loading dose, assessed over the 14-day dosing interval, stratified by device.PK samples taken during the first dosing interval, days 4, 7, 9, 11, 14, were analyzed using noncompartmental analysis (NCA) methods to calculate the geometric mean.
次要结局
- Pharmacokinetics (PK): AUC 0-14 of Tabalumab Based on Body Weight(Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab)
- Number of Participants Reporting Incomplete Tabalumab Dose Administration(Week 0 through Week 12)
- Number of Participants Developing Anti-Tabalumab Antibodies(Week 0 through Week 12)
- Subcutaneous Administration Assessment Questionnaire (SQAAQ) Score(Week 0, Week 4 and Week 8)
- Pharmacokinetics (PK): AUC 0-14 of Tabalumab Based on Injection Site Stratifications(Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab)
- Pharmacokinetics (PK): Cmax of Tabalumab Based on Body Weight(Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab)
- Pharmacokinetics (PK): Cmax of Tabalumab Based on Injection Site Stratifications(Day 4, 7, 9, 11, 14: collected at approximately the same time of day as the administration of the Week 0 injection of tabalumab)