A Randomised, Blinded, Active-Controlled Study to Compare FKB327 Efficacy and Safety With the Comparator Humira® in Rheumatoid Arthritis Patients Inadequately Controlled on Methotrexate
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 728
- 试验地点
- 26
- 主要终点
- American College of Rheumatology (ACR) 20 Response Rate
研究概览
简要总结
The purpose of the study is to compare the effectiveness and safety of FKB327 in comparison to Humira® in rheumatoid arthritis patients who have inadequate disease control on methotrexate.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 18 years or over
- •Patients have been diagnosed with Rheumatoid Arthritis (RA) for at least 3 months
- •Patient has active RA
- •Patient has taken a stable dose of methotrexate for at least 3 months
排除标准
- •Patient has been previously treated with adalimumab
- •Patient has been previously treated or has ongoing treatment with prohibited medications
- •Patient has been immunised with a live or attenuated vaccine in past 4 weeks
- •Patient has positive result for HIV, HBV, HCV or TB infection
- •Other Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
FKB327
Patients will receive FKB327 40 mg every other week by subcutaneous injection. The treatment period will continue for 22 weeks.
干预措施: FKB327 (Drug)
Humira®
Patients will receive Humira® 40 mg every other week by subcutaneous injection. The treatment period will continue for 22 weeks.
干预措施: Humira® (Drug)
结局指标
主要结局
American College of Rheumatology (ACR) 20 Response Rate
时间窗: Week 24
The primary efficacy endpoint was the ACR20 response rate at Week 24. An ACR20 response meant that the patient achieved a 20% improvement in Tender Joint Count and Swollen Joint Count and in at least 3 of the other 5 Core Data Set elements listed below. * Acute phase reactant (CRP) * Patient global assessment of disease activity * Physician global assessment of disease activity * Patient pain scale * Disability/functional questionnaire (patient completed Health Assessment Questionnaire Disability Index \[HAQ-DI\])
次要结局
- Analysis of Serum C-Reactive Protein (CRP) Concentration(Baseline and Week 24)
- Swollen Joint Count(Baseline and Week 24)
- Tender Joint Count(Baseline and Week 24)
- ACR20 Response Rates Over Time(Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24)
- Physician Assessment of Disease Activity(Baseline and Week 24)
- Disease Activity Score 28 (DAS28) Based on C-reactive Protein (DAS28-CRP) Score(Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24)
- ACR50 Response Rates Over Time(Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24)
- ACR70 Response Rates Over Time(Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24)
- Patient Assessment of Disease Activity(Baseline and Week 24)
- Patient's Assessment of Pain(Baseline and Week 24)
- Health Assessment Questionnaire Disability Index (HAQ-DI)(Baseline and Week 24)
- DAS28-CRP Score Over Time(Baseline and Week 24)
- DAS28 Score Based on Erythrocyte Sedimentation Rate (DAS28-ESR)(Baseline, Week 12 and Week 24)