An Open-label, Multiple-dose Study to Assess the Pharmacokinetics, Pharmacodynamics, Preliminary Clinical Activity and Safety of Human Mouse Chimeric Anti-CD22 Monoclonal Antibody (SM03) in Patients With Rheumatoid Arthritis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Systemic Clearance (CL)
研究概览
简要总结
This was an open phase I trial to evaluate the pharmacokinetic, pharmacodynamic, safety and clinical activity profiles of anti-CD22 monoclonal antibody SM03 in patients with active RA.
详细描述
This was an open phase I trial to evaluate the PK, PD, safety,tolerability, efficacy, and immunogenicity of SM03 in patients with RA. The total study duration was approximately 16 weeks for each participant, including a screening period of maximally 4 weeks, a multiple-dose period of 2 weeks (day 0 ~ day 14), and a post-treatment follow-up period of 10 weeks (day 15 ~ day 84).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Rheumatoid arthritis (RA) for ≥ 6 months, diagnosed according to the revised 1987 American College of Rheumatology (ACR) criteria for the classification of rheumatoid arthritis.
- •Moderate to severe active RA with swollen joint count (SJC) ≥ 6 (66 joint count), and tender joint count (TJC) ≥ 8 (68 joint count) at screening and baseline.
- •At screening, either C-reactive protein (CRP) ≥ 0.6 mg/dL (6 mg/L), or Erythrocyte sedimentation rate (ESR) ≥ 28 mm/hour, or Morning stiffness of joint for ≥ 45 minutes.
- •Receiving methotrexate (MTX) 7.5 - 25mg/week (oral) for at least 12 weeks, at a stable dose over the past 4 weeks.
排除标准
- •Females who are pregnant, breastfeeding, or planning a pregnancy during the Treatment Period of and 12 months after the last infusion of study drug.
- •Rheumatic autoimmune disease other than RA.
- •Use of any biological DMARDs for RA within past 6 months.
- •Active infection, or history of serious or chronic infection.
- •Any significant cardiac disease, moderate to severe chronic obstructive pulmonary disease.
- •Allergy or sensitivity to components of the drug vial or any of the materials used for infusion
结局指标
主要结局
Systemic Clearance (CL)
时间窗: Week 0 to 12
Pharmacokinetic endpoint: Systemic Clearance (CL)
Peak Plasma Concentration (Cmax)
时间窗: Week 0, 2
Pharmacokinetic endpoint: Peak Plasma Concentration (Cmax)
Terminal Half-life (T1/2)
时间窗: Week 0 to 12
Pharmacokinetic endpoint:Terminal Half-life (T1/2)
Time to Maximum Plasma Concentration (Tmax)
时间窗: Week 0,2
Pharmacokinetic endpoint: Time to Maximum Plasma Concentration (Tmax)
Area Under the Concentration Time Cure(AUC0-t)
时间窗: Week 0 to 12
Pharmacokinetic endpoint: Area Under the Concentration Time Cure(AUC0-t)
次要结局
- Number of Participants Who Experienced at Least One Adverse Event(Week 0 to 12)
- Change From Baseline in Disease Activity Score (DAS28-ESR) at Week 12(Week 0,2,4,8,12)
- Number of ACR20, ACR50, and ACR70 Responders at Week 12(Week 2,4,8,12)