International Multicenter Comparative Double Blind Study of Pharmacokinetics and Safety of BCD-055 and Remicade in Patients With Ankylosing Spondylitis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Biocad
- 入组人数
- 90
- 试验地点
- 6
- 主要终点
- Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 336 Hours After the Single Infusion of BCD-055/Remicade
研究概览
简要总结
ASART-1 clinical study is a phase 1 study which carried out to establish the pharmacokinetic equivalence and equal safety profile of BCD-055 (infliximab manufactured by JSC BIOCAD, Russia) and Remicade when used as multiple IV infusions for the treatment of ankylosing spondylitis.
详细描述
ASART-1 study is the first step of clinical evaluation of infliximab biosimilar manufactured by JSC BIOCAD, Russia.The aim of this study is to establish that BCD-055 is equivalent to Remicade in terms of pharmacokinetics and safety when used by the standard regimen in patients with ankylosing spondylitis (AS).
The study will enroll 90 patients with active AS, who will be randomized into 2 groups (1:1 ratio): patients from the first group will receive BCD-055 IV at a dose 5 mg/kg on week 0, 2, 6, 14 and 22; patients from the second group will receive Remicade at the same regimen.
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
- Double (Participant, Investigator)
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
- •signed informed consent
- •active ankylosing spondylitis, which exists in patient within last 3 months
- •BASDAI score > or equal to 4 points, spinal pain (by VAS) > or equal to 4 points
- •history of NSAID use for the treatment of AS within last 3 months
- •adequate renal and liver function
- •absence of severe abnormalities in complete blood count
- •consent to use adequate contraception
- •ability to follow Protocol procedures
排除标准
- •previously use of any biologic for AS treatment
- •total ankylosing of the spine
- •known allergy to chimeric proteins or any excipients of BCD-055/Remicade
- •hepatitis B, active hepatitis C, HIV, syphilis
- •known tuberculosis
- •latent forms of tuberculosis
- •any bacterial infection diagnosed within last month which required oral antibiotics (within last 2 weeks) or parenteral antibiotics (within last 4 weeks)
- •drug or alcohol abuse
- •any other disease which can affect assessments or masking some symptoms of AS (severe osteoarthrosis, nervous disorders with impairment of sensory or motor functions, another inflammatory joint disease apart from AS, etc.)
- •severe uncontrolled hypertension
- •chronic heart failure
- •decompensated renal or liver disorders
- •severe uncontrolled diabetes mellitus
- •chronic obstructive lung disease, atopic bronchial asthma, angioedema in anamnesis
- •any mental disorder, incl. severe depression or/and suicide thoughts/actions in anamnesis
- •unstable angina pectoris
- •myocardial infarction within last 12 months
- •Other exclusion criteria could be found in the Full Study Protocol
研究组 & 干预措施
BCD-055 group
BCD-055 (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22
干预措施: Infliximab (BCD-055) (Drug)
Remicade group
Remicade (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22
干预措施: Infliximab (Remicade) (Drug)
结局指标
主要结局
Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 336 Hours After the Single Infusion of BCD-055/Remicade
时间窗: 2 weeks
次要结局
- Maximum Concentration of Infliximab After the Single Infusion of BCD-055/Remicade(2 weeks)
- Time of Maximum Concentration of Infliximab After the Single Infusion of BCD-055/Remicade(2 weeks)
- Maximum Concentration of Infliximab After the 1st, 2nd, 3rd, 4th and 5th Infusion of BCD-055/Remicade(28 weeks)
- Minimum Concentration of Infliximab After the 1st, 2nd, 3rd, 4th and 5th Infusion of BCD-055/Remicade(28 weeks)
- Time of Maximum Concentration of Infliximab After the1st, 2nd, 3rd, 4th and 5th Infusion of BCD-055/Remicade(28 weeks)
- Half Life of Infliximab After the 1st and 5th Infusion of BCD-055/Remicade(2 weeks / 28 weeks)
- Average Concentration of Infliximab at Steady State Phase(28 weeks)
- Percentage of Patients in Each Group Achieving ASAS20(14 weeks / 30 weeks)
- Percentage of Patients in Each Group Achieving ASAS40(14 weeks / 30 weeks)
- Mean Change of BASDAI Score Compared With Baseline(14 weeks / 30 weeks)
- Mean Change of BASMI Score Compared With Baseline(14 weeks / 30 weeks)
- Mean Change of BASFI Score Compared With Baseline(14 weeks / 30 weeks)
- Mean Change of MASES Score Compared With Baseline(14 weeks / 30 weeks)
- Mean Change of SF36 Score Compared With Baseline(14 weeks / 30 weeks)
- Mean Change of Chest Expansion Compared With Baseline(14 weeks / 30 weeks)
- Frequency of AE/SAE After the Single Infusion of BCD-055/Remicade(2 weeks)
- Total Frequency of AE/SAE Within the Whole Time of the Study(30 weeks)
- Total Frequency of Grade 3-4 Laboratory Abnormalities Within the Whole Time of the Study(30 weeks)
- Percentage of Patients in Whom Bind or Neutralizing Antibodies to Infliximab Were Detected(screening / 14 weeks / 30 weeks)
- Frequency of Early Withdrawal Due to AE/SAE(30 weeks)