International Multi-center Comparative Double-blind Randomized Clinical Trial of Efficacy and Safety of BCD-055 (JSC "BIOCAD", Russia) and Remicade® in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Biocad
- 入组人数
- 426
- 试验地点
- 39
- 主要终点
- Ratio of patients with ACR20 response after 14 weeks of therapy
研究概览
简要总结
BCD-055-3 is international multi-center comparative double-blind randomized clinical trial of efficacy and safety of BCD-055 (JSC "BIOCAD", Russia) and Remicade® in combination with methotrexate in patients with active 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Active rheumatoid arthritis according to criteria of American College of Rheumatologists (2010), that was diagnosed at least 6 months prior to screening.
- •Active rheumatoid arthritis at screening despite of therapy with methotrexate for 3 last months.
- •Use of methotrexate in stable dose for at least 4 weeks before screening (10-25 mg per week).
- •History of ineffective treatment with basic antiinflammatory drugs (including methotrexate).
排除标准
- •Previous therapy of rheumatoid arthritis with monoclonal antibodies (including anti-tumor necrosis factor drugs)
- •Felty's syndrome
- •Functional status - class IV according to ACR classification (1991)
- •Low activity of rheumatoid arthritis (DAS28-CRP(4) index less than 3.2)
- •Patient needs corticosteroids in a dose more than 10 mg (recalculated to prednisolone) before signing informed consent.
- •Patients needs equal of less than 10 mg prednisolone but the dose was not stable for last 4 weeks prior to infliximab treatment
- •Prior use of disease-modifying antirheumatic drugs including methotrexate, sulfasalazin, chloroquine or hydroxychloroquine for up to 4 weeks before randomization.
- •Prior use of alkylating agents for up to 12 months prior to signing informed consent.
- •Intraarticular use of corticosteroids for up to 4 weeks before randomization.
- •Prior use of live or attenuated vaccines for up to 8 weeks before signing informed consent.
- •Diagnosis of tuberculosis.
- •Body mass more than 130 kg.
研究组 & 干预措施
BCD-055
Patients in this group will receive BCD-055 in a dose of 3 mg/kg on Week 0, Week 2, Week 6, Week 14, Week 22, Week 30, Week 38, Week 46, Week 54.
干预措施: BCD-055 (Biological)
BCD-055
Patients in this group will receive BCD-055 in a dose of 3 mg/kg on Week 0, Week 2, Week 6, Week 14, Week 22, Week 30, Week 38, Week 46, Week 54.
干预措施: Methotrexate (Drug)
BCD-055
Patients in this group will receive BCD-055 in a dose of 3 mg/kg on Week 0, Week 2, Week 6, Week 14, Week 22, Week 30, Week 38, Week 46, Week 54.
干预措施: Folic acid (Drug)
Remicade®
Patients in this group will receive Remicade® in a dose of 3 mg/kg on Week 0, Week 2, Week 6, Week 14, Week 22, Week 30, Week 38, Week 46, Week 54.
干预措施: Remicade® (Biological)
Remicade®
Patients in this group will receive Remicade® in a dose of 3 mg/kg on Week 0, Week 2, Week 6, Week 14, Week 22, Week 30, Week 38, Week 46, Week 54.
干预措施: Methotrexate (Drug)
Remicade®
Patients in this group will receive Remicade® in a dose of 3 mg/kg on Week 0, Week 2, Week 6, Week 14, Week 22, Week 30, Week 38, Week 46, Week 54.
干预措施: Folic acid (Drug)
结局指标
主要结局
Ratio of patients with ACR20 response after 14 weeks of therapy
时间窗: Week 14
Ratio of patients who developed a decrease in American College of Rheumatologists (ACR) score by 20% or more after 14 weeks of therapy with study drug
次要结局
- Ratio of patients with ACR20 response after 30 and 54 weeks of therapy(Week 30, Week 54)
- Ratio of patients with ACR50 and 70 response after 14, 30 and 54 weeks of therapy(Week 14, Week 30, Week 54)
- Ratio of patients with low activity of rheumatoid arthritis according to index DAS28-CRP(4) after 14, 30 and 54 weeks of therapy(Week 14, Week 30, Week 54)
- Ratio of patients with low activity of rheumatoid arthritis according to index CDAI after 14, 30 and 54 weeks of therapy(Week 14, Week 30, Week 54)
- Ratio of patients with low activity of rheumatoid arthritis according to index SDAI after 14, 30 and 54 weeks of therapy(Week 14, Week 30, Week 54)
- Ratio of patients with remission of rheumatoid arthritis according to index DAS28 after 14, 30 and 54 weeks of therapy(Week 14, Week 30, Week 54)
- Ratio of patients with remission of rheumatoid arthritis according to index CDAI after 14, 30 and 54 weeks of therapy(Week 14, Week 30, Week 54)
- Ratio of patients with remission of rheumatoid arthritis according to index SDAI after 14, 30 and 54 weeks of therapy(Week 14, Week 30, Week 54)
- Ratio of patients with remission of rheumatoid arthritis according to ACR-EULAR criteria after 14, 30 and 54 weeks of therapy(Week 14, Week 30, Week 54)
- Mean SF-36 score at screening and after 14, 30 and 54 weeks of therapy(Screening, Week 14, Week 30, Week 54)
- CRP(Screening, Week 14, Week 30, Week 54)
- ESR(Screening, Week 14, Week 30, Week 54)
- Roentgenologic characteristics of abnormal joints after 54 weeks of therapy(Week 54)
- Frequency of AE/SAE(54 weeks)
- Frequency of AE 3-4 grade CTCAE(54 weeks)
- Frequency of early withdrawals due to AE/SAE(54 weeks)
- Percentage of patients who developed binding and neutralizing antibodies to infliximab(Screening, Week 14, Week 30, Week 54)