A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate Safety and Clinical Efficacy of Two Different Doses of F8IL10 (Dekavil) Administered Subcutaneously to Patients With Active Rheumatoid Arthritis Receiving Methotrexate.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 27
- 试验地点
- 8
- 主要终点
- Change from baseline in DAS28-CRPscore
研究概览
简要总结
A multicenter, randomized, parallel assignment, double blind, placebo-controlled, safety/efficacy phase II study of two different dosages of subcutaneous F8IL10 in patients with active rheumatoid arthritis receiving MTX.
详细描述
The study is designed to formally demonstrate the superiority of F8IL10 vs placebo and to further evaluate safety and efficacy of two different dosages of F8IL10 when administered to patients receiving MTX.
Patients will be enrolled and double-blind, parallel assigned (via automated randomization system) in a 1:1:1 fashion to one of three different arms:
- Arm 1: placebo + MTX
- Arm 2: F8IL10 30 µg/kg + MTX
- Arm 3: F8IL10 160 µg/kg + MTX
F8IL10 or placebo will be subcutaneously injected once a week for 8 weeks. Treatment will terminate at the earliest of the following: completion of the 8 weeks of therapy, withdrawal of informed consent, unacceptable toxicity/intolerability of the study drug or need to increase MTX, oral corticosteroids or NSAIDs dosages above baseline levels or need to introduce a new DMARD or biologic therapy to control rheumatoid arthritis activity. The study will be conducted in a double blind fashion.
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 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm 1
Placebo
干预措施: MTX (Drug)
Arm 1
Placebo
干预措施: Placebo (Drug)
Arm 2
F8IL10, 30 μg/kg
干预措施: F8IL10 (Drug)
Arm 2
F8IL10, 30 μg/kg
干预措施: MTX (Drug)
Arm 3
F8IL10, 160 μg/kg
干预措施: F8IL10 (Drug)
Arm 3
F8IL10, 160 μg/kg
干预措施: MTX (Drug)
结局指标
主要结局
Change from baseline in DAS28-CRPscore
时间窗: At week 9
Mean change from baseline in DAS28-CRP between F8IL10 and placebo arms.
次要结局
- Inflammatory parameters CRP or ESR and change from baseline(1) from week 1 up to week 9; 2) from week 12 up to week 32, every 4 weeks)
- Absolute score and change from baseline in physician's and patient's global assessments of disease activity (100 mm VAS)(1) from week 1 up to week 9; 2) from week 12 up to week 32, every 4 weeks)
- Absolute score and change from baseline in patient assessment of the pain intensity at each visit (100 mm VAS)(1) from week 1 up to week 9; 2) from week 12 up to week 32, every 4 weeks)
- Percentage of Participants With Worst On-Study Hematological and Chemistry Abnormalities(1) from week 1 up to week 9; 2) from week 12 up to week 32, every 4 weeks)
- Clinically Meaningful Changes in Vital Signs and Physical Examinations(1) from week 1 up to week 9; 2) from week 12 up to week 32, every 4 weeks)
- Changes in absolute counts and relative percentages of main biomarker/cytokines(1) day 14 - 0 (screening); 2) at week 1; 3) at week 5; 4) at week 9 (EoT); 5) from week 12 up to week 32, every 4 weeks)
- Proportion of patients that experienced significant change from baseline in functional status (SF-36)(1) week 9; 2) from week 12 up to week 32, every 4 weeks)
- Clinical Remission and low-disease activity (DAS28-CRP)(1) week 9; 2) from week 12 up to week 32, every 4 weeks)
- HAQ score and change from baseline in HAQ score(1) week 1; 2) week 9; 3) from week 12 up to week 32, every 4 weeks)
- Number of Participants with Adverse Events(Up to 8 months from randomization)
- Absolute count and change from baseline in tender and swollen joint counts(1) from week 1 up to week 9; 2) from week 12 up to week 32, every 4 weeks)
- Proportion of patients that experienced significant change from baseline in functional status (HAQ-DI)(1) week 9; 2) from week 12 up to week 32, every 4 weeks)
- Response rate according to ACR and EULAR criteria(1) week 9; 2) from week 12 up to week 32, every 4 weeks)
- Clinical Remission and low-disease activity (SDAI score)(1) week 9; 2) from week 12 up to week 32, every 4 weeks)
- Human anti-fusion protein antibodies (HAFA) levels(1) day 14 - 0 (screening); 2) at week 1; 3) at week 5; 4) at week 9 (EoT); 5) from week 12 up to week 32, every 4 weeks)