NCT03574545已完成1 期
A Randomized, Open Label, Multiple Dose, Parallel Group Study to Assess the Safety and Pharmacokinetic Comparability of Two VAY736 Drug Products in Patients With Rheumatoid Arthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Pharmacokinetic comparability at steady state - AUCtau
研究概览
简要总结
This study will assess the safety and pharmacokinetic comparability of two VAY736 drug products in patients with rheumatoid arthritis.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fulfill 2010 ACR/EULAR criteria for RA Aletaha et al 2010 at Screening
- •Active disease defined as ≥ 2 swollen joints (of 58 evaluable joints) and ≥ 2 tender joints (of 60 evaluable joints) despite stable MTX ≤ 25 mg/week and/or hydroxychloroquine ≤ 400 mg/day treatment for at least 2 months prior to randomization
排除标准
- •Prior or previous use of (specific dosages and intervals prior to study start may apply): other investigational drugs, B-cell depleting therapy (e.g. rituximab), monoclonal antibodies (mAb), i.v. / s.c. Ig, thymoglobulin, i.v. or oral cyclophosphamide, oral cyclosporine, soluble cytokine receptors, azathioprine.
- •Currently receiving prednisone >10 mg/day (or equivalent oral glucocorticoid) or dose adjustment within 2 weeks prior to randomization
- •Active viral, bacterial or other infections requiring systemic treatment at the time of screening or enrollment, or history of recurrent clinically significant infection or of bacterial infections with encapsulated organisms
- •Receipt of live/attenuated vaccine within a 2-month period before randomization
- •Pregnant or nursing (lactating) women
- •Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception from screening and for 4 months after stopping of investigational drug
研究组 & 干预措施
Reference VAY736 Drug Product
Active Comparator
Powder for solution for injection / infusion
干预措施: ianalumab (Biological)
Test VAY736 Drug Product
Experimental
Solution for injection
干预措施: ianalumab (Biological)
结局指标
主要结局
Pharmacokinetic comparability at steady state - AUCtau
时间窗: Week 8 - 12
The area under the serum ianalumab concentration-time curve from time zero to the end of the dosing interval (AUCtau)
Safety and tolerability as measured by the number of patients with adverse events
时间窗: Week 0 - 112
The number of patients with adverse events after repeated subcutaneous (s.c) injections of a fixed dose of ianalumab
Pharmacokinetic comparability at steady state - Cmax
时间窗: Week 8 - 12
Observed maximum serum concentration of ianalumab following drug administration (Cmax)
次要结局
- Pharmacokinetic comparability after the last dose - Tmax(Week 8 - 12)
- Pharmacokinetic comparability after the first dose - Cmax(Week 0 - 4)
- Pharmacokinetic comparability after the first dose - Tmax(Week 0 - 4)
- Pharmacokinetic comparability of two ianalumab drug products after the last dose - AUCinf(Week 8 - 12)
- Pharmacokinetic comparability after the last dose - T1/2(Week 8 - 12)
- Pharmacokinetic comparability at the end of each dosing interval - Ctrough(Week 0 - 12)
- Pharmacodynamic effect as measured by B-cell level(Week 0 - 112)
- Immunogenicity as measured by Anti-Drug Antibodies(Week 0 - 112)
- Pharmacokinetic comparability after the first dose - AUCtau(Week 0 - 4)
研究者
研究点 (1)
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