NCT01676701终止3 期
Pharmacokinetic Evaluations of Tabalumab Following Subcutaneous Administration by Prefilled Syringe or Auto Injector in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Tabalumab After Loading Dose
研究概览
简要总结
The purpose of this study is to evaluate the serum concentration of tabalumab after the administration using either prefilled syringe or auto-injector after the initial loading dose and after 12 weeks of treatment. Treatment period is followed by 40 weeks optional safety extension.
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
- •Ambulatory males or females ≥18 years of age
- •Diagnosis of adult-onset RA
- •Active RA (at least 8/68 tender and at least 8/66 swollen joints)
- •Screening C-reactive protein (CRP) >1.2 times the upper limit of normal (ULN) or a screening erythrocyte sedimentation rate (ESR) >28 millimeters per hour (mm/hr)
- •Documented history of, or current, positive rheumatoid factor (RF) and/or anti-cyclic citrullinated peptide antibody (anti-CCP Ab) test
- •Regular use of methotrexate (MTX) for at least 12 weeks and stable dose (10 to 25 mg/week) for at least 8 weeks prior to baseline
- •American College of Rheumatology (ACR) functional class I, II, or III
- •Able and willing to inject tabalumab by themselves (or have an assistant who will inject tabalumab) and able and willing to complete all study procedures
- •Able and willing to have blood drawn for pharmacokinetic (PK) sampling
排除标准
- •Use of oral corticosteroids at average daily doses of >10 milligrams per day (mg/day) of prednisone or its equivalent within 6 weeks prior to baseline
- •Injection of any parenteral (including intraarticular) corticosteroid within 6 weeks of baseline
- •Have previously discontinued treatment with a biologic disease-modifying antirheumatic drug (DMARD) or a novel drug that interrupts cytokine signaling [for example, Janus kinase (JAK) inhibitors] due to insufficient efficacy
- •Participants who had discontinued biologic DMARDS for reasons other than efficacy will not be excluded but must have done so prior to baseline
- •Participants who discontinued a JAK inhibitor for lack of efficacy
- •Participants who discontinued a JAK inhibitor for reasons other than efficacy will not be excluded, but must have done so prior to baseline for 21 days
- •Previous severe reaction to any biologic therapy that, in the opinion of the Investigator, would pose an unacceptable risk to the participant if participating in the study
- •Have had an inadequate response to treatment with 3 or more of the following DMARDs prescribed alone or in combination at approved doses for a minimum of 90 days: leflunomide, azathioprine, cyclosporine, and/or sulfasalazine
- •Use of other DMARDs (for example, gold salts, cyclosporin, azathioprine, or any other immunosuppressives) other than MTX, hydroxychloroquine, chloroquine, or sulfasalazine, or the use of a JAK inhibitor in the 8 weeks prior to baseline
研究组 & 干预措施
Tabalumab Auto-Injector
Experimental
Tabalumab 180 milligram (mg) loading dose administered using auto-injectors at Week 0 as 2 subcutaneous (SC) injections (90 mg each), followed by a 90 mg SC injection every 2 weeks (Q2W) up to Week 12.
干预措施: Tabalumab Auto-Injector (Drug)
Tabalumab Prefilled Syringe
Experimental
Tabalumab 180 mg loading dose administered using prefilled syringes at Week 0 as 2 SC injections (90 mg each), followed by a 90 mg SC injection Q2W up to Week 12.
干预措施: Tabalumab Prefilled Syringe (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Tabalumab After Loading Dose
时间窗: Days 4, 7, 9, 11, and 14 after loading dose administered
PK: Area Under the Concentration Time Curve From Time 0 to 14 Days [AUC(0-14)]
时间窗: Days 4, 7, 9, 11, and 14 after loading dose administered
次要结局
- Change From Baseline to 12-Week Endpoint in Achieving American College of Rheumatology (ACR) Core Set(Baseline, Week 12)
- Percent Change From Baseline to 12-Week Endpoint in American College of Rheumatology (ACR-N) Index(Baseline, Week 12)
- Change From Baseline to 12-Week Endpoint in Disease Activity Score Based on a 28-Joint Count and C-Reactive Protein (DAS28-CRP) Level(Baseline, Week 12)
- Percentage of Participants Achieving ACR Response(Week 12)
- Percentage of Participants Achieving European League Against Rheumatism Responder Index Based on the 28-Joint Count (EULAR-28)(Week 12)
- Number of Operation Failures(Week 12)
- Number of Participants Developing Anti-Tabalumab Antibodies(Week 12)
- Change From Baseline Score in Subcutaneous Administration Assessment Questionnaire (SQAAQ)(Baseline, Weeks 4 and 8)
研究者
研究点 (1)
Loading locations...
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