NCT02683564Unknown3 期
A Study of BOW015 (Infliximab-EPIRUS) and Infliximab in Patients With Active Rheumatoid Arthritis on Stable Methotrexate: The UNIFORM Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 548
- 主要终点
- American College of Rheumatology (ACR) 20 clinical response
研究概览
简要总结
This is a prospective, randomized, double-blind, parallel group, multicentre global phase 3 clinical study to evaluate the efficacy, safety and immunogenicity of BOW015 (infliximab-EPIRUS) compared to Remicade in subjects with active Rheumatoid Arthritis (RA) despite Methotrexate (MTX) therapy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female, aged 18 to 80
- •Diagnosis of Rheumatoid Arthritis (RA) according to the revised ACR/ EULAR 2010 classification criteria for RA
- •Patients must have ACR/EULAR 2010 classification criteria score ≥ 6
- •Patients must have active disease
- •Patients must have been on treatment with methotrexate
排除标准
- •Prior use of infliximab, adalimumab, certolizumab, golimumab, tocilizumab, rituximab, or etanercept or any other biological treatment
- •Patients with any prior or current use of anakinra and abatacept
- •Patients with suspected or confirmed current active tuberculosis (TB)
- •Patients with latent tuberculosis must start treatment for latent tuberculosis
- •Patients who have a current or past history of chronic infection with Hepatitis B, Hepatitis C, or infection with Human Immunodeficiency Virus-1 or-2
- •History of completely excised and cured squamous carcinoma of the uterine cervix, cutaneous basal cell carcinoma or cutaneous squamous cell carcinoma
- •History of lymphoproliferative disease
- •History or presence of any other form of malignancy
- •Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic or cerebral disease
- •History of congestive heart failure or unstable angina
- •History of any autoimmune disease other than RA
- •Major surgery within 12 weeks and planned major surgery
- •History of serious infection
- •Pre-existing central nervous system demyelinating disorders
- •Administration of live or live-attenuated vaccine within 4 weeks of screening
- •Clinically significant adverse reaction to murine or chimeric proteins
- •History or presence of any medical or psychiatric condition or disease, or clinically significant laboratory abnormality
- •Participation in any clinical study of an investigational product within the previous 3 months prior to screening
研究组 & 干预措施
BOW015
Experimental
Infliximab-EPIRUS, 3mg/kg body weight as intra venous infusion at weeks 0, 2, 6 then every 8 weeks thereafter up to Week 46.
干预措施: BOW015 (Drug)
Remicade
Active Comparator
Remicade (infliximab) , 3mg/kg body weight as intra venous infusion at weeks 0, 2, 6 then every 8 weeks thereafter up to Week 46.
干预措施: Remicade (Drug)
结局指标
主要结局
American College of Rheumatology (ACR) 20 clinical response
时间窗: 16 weeks
次要结局
- ACR20(54 weeks)
- Diseases Activity Score (DAS)28 calculated with C-reactive protein (CRP)(54 weeks)
- Health Assessment Questionnaire-Disability Index (HAQ-DI)(54 weeks)
研究者
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