Effectiveness and Safety of Tumor Necrosis Factor Receptor Fusion Protein(Yisaipu) Combined With Tripterygium Wilfordii for Active Rheumatoid Arthritis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 504
- 试验地点
- 1
- 主要终点
- The American College of Rheumatology 50 (ACR50) response at 12 weeks
研究概览
简要总结
In this 24-week, multi-center, randomized, double-blind study, the investigators will evaluate the efficacy and safety profile of subcutaneously injected Yisaipu, a Tumor Necrosis Factor Receptor Fusion Protein, combined with oral Tripterygium Wilfordii for patients with active rheumatoid arthritis.
详细描述
This study evaluates the efficacy and safety of YISAIPU plus Tripterygium wilfordii (T2w) for the treatment of RA patients. YISAIPU is a recombinant human tumor necrosis factor receptor fusion protein, and tripterygium wilfordii is a chloroform/methanol extract of Tripterygium wilfordii Hook F.
Objectives:
- To compare the efficacy of YISAIPU plus T2w versus MTX monotherapy for the treatment of signs and symptoms of RA.
- To evaluate the safety of YISAIPU plus T2w in patients with RA for 24 weeks.
Design:
This is a randomized, 24-week, double-blind, parallel group study, and 506 patients with active RA will be randomized in a 1:1:1:1 ratio to one of the following four parallel treatment arms:
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years with informed consent
- •Diagnosis of rheumatoid arthritis (according to 2010 ACR/EULAR classification criteria)
- •Disease duration > 6 weeks
- •Swollen joint (SJC)≥4 and tender joint count(TJC)≥4
- •ESR >28 mm/hr or C-reactive protein > 1.5 ULN
- •Positive RF or anti-CCP antibody on screening
- •Class I, II or III of the ACR 1991 Revised Criteria for Global Functional Status in RA
- •No evidence of active or latent or inadequately treated Mycobacterium tuberculosis infection
排除标准
- •Pregnant, lactating or further fertility requirements
- •Previously received any biologic agents.
- •Recently (<12 weeks) received methotrexate, leflunomide, salazosulfapyridine, azathioprine, cyclosporine, mycophenolate mofetil or Tripterygium Wilfordii.
- •Active or chronic infection, including HIV, HCV, HBV, tuberculosis.
- •History of any other rheumatic autoimmune disease
- •History of any lymphoproliferative disorder
- •Malignancy or history of malignancy.
- •Abnormal laboratory tests, including: Hemoglobin <8.5 g/dL, White blood cell count <3.5 x 109/L, Platelet count <100 x 109/L, AST/ALT >1.5 ULN, and serum creatine > 1.5 mg/dL.
- •Severe, progressive, or uncontrolled cardiac, pulmonary, renal, hepatic, gastrointestinal, hematologic, metabolic, endocrine or neurologic disease
研究组 & 干预措施
Yisaipu + MTX
Treated with subcutaneously injected Yisaipu, oral methotrexate and a placebo.
干预措施: Methotrexate (Drug)
MTX
Treated with oral methotrexate and two placebos.
干预措施: Methotrexate (Drug)
Tripterygium Wilfordii
Treated with oral Tripterygium Wilfordii and two placebos.
干预措施: Tripterygium Wilfordii (Drug)
Yisaipu + MTX
Treated with subcutaneously injected Yisaipu, oral methotrexate and a placebo.
干预措施: Yisaipu (Drug)
Yisaipu + Tripterygium Wilfordii
Treated with subcutaneously injected Yisaipu, oral methotrexate and a placebo.
干预措施: Tripterygium Wilfordii (Drug)
Yisaipu + Tripterygium Wilfordii
Treated with subcutaneously injected Yisaipu, oral methotrexate and a placebo.
干预措施: Yisaipu (Drug)
结局指标
主要结局
The American College of Rheumatology 50 (ACR50) response at 12 weeks
时间窗: week 12
The difference of ACR50 between Arm 4 (Yisaipu + Tripterygium Wilfordii) and Arm 1 (MTX) at week 12.
次要结局
- The American College of Rheumatology 20/70 (ACR20/ACR70) response at 12 weeks(week 12)
- The American College of Rheumatology 20/50/70 (ACR20/ACR50/ACR70) response at 24 weeks(week 24)
- The Disease Activity Score-28 (DAS28) response at 24 weeks(week 24)
- The European League Against Rheumatism (EULAR) response at 12 weeks(week 12)
- Health Assessment Questionnaire without Didability Index (HAQ-DI) at 12 weeks(week 12)
研究者
Xuan Zhang
Professor
Peking Union Medical College Hospital