NCT02762812已完成3 期
International Multi-center Comparative Double-blind Randomized Clinical Trial to Evaluate Efficacy and Safety of BCD-055 (JSC "BIOCAD", Russia) and Remicade® in Patients With Ankylosing Spondylitis
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Biocad
- 入组人数
- 199
- 试验地点
- 1
- 主要终点
- Ratio of patients with ASAS20 response after 30 weeks of therapy
研究概览
简要总结
BCD-055-2 is international multi-center comparative double-blind randomized clinical trial to evaluate efficacy and safety of BCD-055 (JSC "BIOCAD", Russia) and Remicade® in patients with ankylosing spondylitis.
BCD-055 is biosimilar of infliximab (JSC "BIOCAD", Russia)
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 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 according to modified criteria of New York classification (1984), that was diagnosed at least 3 months prior to screening.
- •Active disease according to BASDAI (score 4 or more) if nonsteroidal antiinflammatory drugs were used in the last 3 month prior to screening.
- •Mean backache intensity equals 4 points or more.
排除标准
- •Previous therapy of ankylosing spondylitis with monoclonal antibodies (including tumor necrosis factor)
- •Total spinal ankylosis
- •History of tuberculosis
- •Body mass more than 120 kg
- •Patient is taking corticosteroids for up to 4 weeks in a dose more than 10 mg (recalculated to prednisolone) before signing informed consent.
- •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.
研究组 & 干预措施
BCD-055
Experimental
Patients in this group will receive BCD-055 in a dose of 5 mg/kg on Week 0, Week 2, Week 6, Week 14, Week 22, Week 30, Wekk 38, Week 46, Week 54.
干预措施: BCD-055 (Biological)
Remicade®
Active Comparator
Patients in this group will receive Remicade® in a dose of 5 mg/kg on Week 0, Week 2, Week 6, Week 14, Week 22, Week 30, Wekk 38, Week 46, Week 54.
干预措施: Remicade® (Biological)
结局指标
主要结局
Ratio of patients with ASAS20 response after 30 weeks of therapy
时间窗: Week 30
Ratio of patients who developed a decrease in ankylosing spondylitis assessment score (ASAS) by 20% or more after 30 weeks of therapy with BCD-055.
次要结局
- Ratio of patients with ASAS20 response after 14 and 54 weeks of therapy(Week 14, Week 54)
- Ratio of patients with ASAS40 response after 14, 30 and 54 weeks of therapy(Week 14, Week 30, Week 54)
- Frequency of AE/SAE(54 weeks)
- Mean change in BASDAI 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(Week 14, Week 30, Week 54)
- Frequency of AE 3-4 grade CTCAE(54 weeks)
- Mean change in BASMI after 14, 30 and 54 weeks of therapy(Week 14, Week 30, Week 54)
- Mean change in BASFI after 14, 30 and 54 weeks of therapy(Week 14, Week 30, Week 54)
- Mean change in MASES after 14, 30 and 54 weeks of therapy(Week 14, Week 30, Week 54)
- Mean quantity of abnormal peripheral joints after 14, 30 and 54 weeks of therapy(Week 14, Week 30, Week 54)
- Mean chest excursion at screening and after 14, 30 and 54 weeks of therapy(Week 14, Week 30, Week 54)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Comparative Clinical Trial of Efficacy and Safety of BCD-055 and Remicade® in Combination With Methotrexate in Patients With Active Rheumatoid ArthritisRheumatoid ArthritisNCT02762838Biocad426
已完成
3 期
International Multicenter Comparative Randomized Placebo-controlled Clinical Study of Efficacy and Safety of BCD-085 in Patients With Ankylosing SpondylitisAnkylosing SpondylitisNCT03447704Biocad228
已完成
3 期
A Safety and Efficacy Study of BCD-021 With Paclitaxel and Carboplatin Compared to Avastin With Paclitaxel and Carboplatin in Non-Small Cell Lung CancerNon-small Cell Lung CancerNCT01763645Biocad353
已完成
2 期
The BCD-089 (aIL6R) in Patients With Active Rheumatoid ArthritisSeropositive RANCT03455842Biocad105
已完成
3 期
An International, Multicenter, Randomized, Double-Blind, Double-Masked Study of the Efficacy and Safety of BCD-132 (JSC BIOCAD, Russia) Using an Active Reference Drug (Teriflunomide) for the Treatment of Patients With Multiple SclerosisMultiple SclerosisNCT05385744Biocad336