Prospective Clinical Study to Observe the Efficacy and Safety of Iguratimod in Rheumatoid Arthritis and Early Rheumatoid Arthritis Patients for 6 Months Treatment in China
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- The percentage of patients who achieve clinical remission at week 24 using European League Against Rheumatism (EULAR) response criteria DAS28
研究概览
简要总结
This study is designed to observed prospectively the efficacy and safety of 6 months treatment of iguratimod alone, or with methotrexate (MTX), hydroxychloroquine (HCQ) and prednisone step by step on Chinese rheumatoid arthritis (RA) and early rheumatoid arthritis (ERA) patients who were naïve or shown insufficiency response or intolerance to DMARDs. If volunteered, patients who completed the 6-month study can continue to follow our plans for 24 months.
详细描述
This study will enroll 200 cases of rheumatoid arthritis (RA) and early rheumatoid arthritis (ERA) patients in China, who are naïve or shown insufficiency response or intolerance to DMARDs. The participants plan to be treated with iguratimod alone, or along with methotrexate (MTX)/ hydroxychloroquine (HCQ) / prednisone (Pred) step by step for 6 months if participants are in medium or high disease activity (DAS28≥3.2). Participants can choose to continue the study up to 24 months.The efficacy and safety of 6 months and 24 months Iguratimod treatment in RA and ERA patients will be evaluated with DAS28-ESR and other disease activity indices.
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
- 16 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •RA: Patients diagnosed based on 1987 ACR classification criteria for rheumatoid arthritis(RA);
- •ERA: Subjects diagnosed by the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR); or by 2012 Chinese classification criteria of early rheumatoid arthritis (ERA), and not match the 1987 ACR criteria for RA.
- •Age ≥16 years;
- •Extra-articular manifestations (such as pulmonary fibrosis, proteinuria, leukopenia and peripheral neuropathy ) of RA patients are stable or no significant progress;
- •Patients can be naïve to any DMARDs, or relapse due to DMARDs drug suspended;
- •Patients have a history of using csDMARDs including csDMARDs（methotrexate，leflunomide, hydroxychloroquine, sulfasalazine, tacrolimus) , any biologic DMARDs（TNFi，tocilizumab or Tofacitinib），glucocorticoid (prednisone，methylprednisolone) or Chinese traditional Medicine（including tripterygium Glycosides, sinomenine）for 3 months, but couldn't achieve clinical remission or intolerance；
排除标准
- •Patients with acute or chronic infections such as active bacterial, viral, fungal, tuberculosis infection or active hepatitis B;
- •Platelet counts(PLT) <80 x 10^9 / L, or white blood cell (WBC) <3 x 10^9 / L;
- •Propionate acid aminotransferase (ALT) or aspartate aminotransferase (AST) is two times higher than the upper limit of normal;
- •Renal insufficiency: serum Cr ≥ 176 umol / L;
- •Pregnant or nursing women (breastfeeding) ；
- •Patients has a history of malignancy (cure time in less than 5 years);
- •Patients with severe or poorly controlled hypertension, diabetes or cardiac dysfunction;
- •Other comorbidities that cannot be treated with immune suppressants. In addition, once patients experience severe adverse drug reactions、ineffective treatment or rapid progression of rheumatoid arthritis, then quit this research.
研究组 & 干预措施
Iguratimod
The participants plan to be treated with iguratimod alone, or along with methotrexate (MTX), hydroxychloroquine (HCQ) , prednisone (Pred) step by step
干预措施: Iguratimod (Drug)
Iguratimod
The participants plan to be treated with iguratimod alone, or along with methotrexate (MTX), hydroxychloroquine (HCQ) , prednisone (Pred) step by step
干预措施: MTX (Drug)
Iguratimod
The participants plan to be treated with iguratimod alone, or along with methotrexate (MTX), hydroxychloroquine (HCQ) , prednisone (Pred) step by step
干预措施: HCQ (Drug)
Iguratimod
The participants plan to be treated with iguratimod alone, or along with methotrexate (MTX), hydroxychloroquine (HCQ) , prednisone (Pred) step by step
干预措施: Pred (Drug)
结局指标
主要结局
The percentage of patients who achieve clinical remission at week 24 using European League Against Rheumatism (EULAR) response criteria DAS28
时间窗: week 24
The percentage of patients whose Disease Activity Score in 28 Joints (DAS28) achieve remission（DAS28-ESR≤ 2.6）and Low Disease Activity (DAS28-ESR ≤ 3.2). The DAS28 is a composite score derived from 4 of these measures，that is the count of tender joint count（TJC, 0-28）and swollen joint count（SJC, 0-28）, measure erythrocyte sedimentation rate (ESR, mm/h) or C reactive protein (CRP, mg/L) and to make a patient assessment of disease activity i.e. 'global assessment of health' (GH) using a 100 mm visual analogue scale (VAS) with 0 = best, 100 = worst. DAS28 values were calculated as follows: DAS28- ESR = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 x GH. High disease activity: DAS28-ESR \> 5.1; Moderate disease activity: 5.1≥ DAS28 \> 3.2 to 5.1; Low disease activity (LDA) and Remission mean Clinical remission.
次要结局
- The percentage of patients who achieve clinical remission using DAS28-ESR at week 12(week 12)
- The percentage of patients who achieve clinical remission using DAS28-ESR at week 96(week 96)
- Percentage of Disease Activity Score 28 (DAS28)-ESR Criteria Responders at week 48(week 48)
- Percentage of participants achieving ACR/EULAR remission at week 24(week 24)
- Percentage of participants achieving ACR/EULAR remission at week 48(week 48)
- Change from baseline Clinical Disease Activity Index (CDAI)(Up to week 96)
- Change From Baseline in C-reactive Protein (CRP)(Up to week 96)
- The percentage of patients who achieve clinical remission using DAS28-ESR at week 48(week 48)
- Percentage of participants achieving ACR/EULAR remission at week 12(week 12)
- Change From Baseline in Erythrocyte Sedimentation Rate (ESR)(Up to week 96)
- Incidence of participant withdrawal(Up to week 96)
- Number of participants with"adverse events (AEs)"(Up to week 96)
- Percentage of Disease Activity Score 28 (DAS28) -ESR Criteria Responders at week 12(week 12)
- Percentage of Disease Activity Score 28 (DAS28)-ESR Criteria Responders at week 24(week 24)
- Percentage of American College of Rheumatology [ACR] 20 Criteria Responders every 3 months(Up to week 96)
- Change from baseline Simplified Disease Activity Index (SDAI)(Up to week 96)
- Percentage of Disease Activity Score 28 (DAS28)-ESR Criteria Responders at week 96(week 96)
- Percentage of participants achieving ACR/EULAR remission at week 96(week 96)
- Change from baseline Health Assessment Questionnaire Disability Index (HAQ-DI)(Up to week 96)
研究者
Qiang Shu
Chief Physician
Qilu Hospital of Shandong University