NCT01548001Unknown4 期
A Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Iguratimod Alone or Iguratimod in Combination With Methotrexate Versus Methotrexate Alone in Patients With Rheumatoid Arthritis
适应症
干预措施
试验速览
- 阶段
- 4 期
- 入组人数
- 910
- 试验地点
- 1
- 主要终点
- Percentage of patients with ACR 20 response
研究概览
简要总结
This study is intended to evaluate the efficacy and safety of Iguratimod alone or Iguratimod in combination with Methotrexate (MTX) versus Methotrexate alone in patients with Rheumatoid Arthritis (RA).
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
- •Subjects with a diagnosis of RA according to the diagnostic criteria of the American College of Rheumatology (ACR) (revised in 1987)
- •Rheumatoid Arthritis for 3 months to 2 years from the time of the initial diagnosis
- •Subjects have active RA at the time of screening
- •Subjects are naive to MTX or RA related biologics
- •Written informed consent
排除标准
- •Preceding treatment with DMARDs, immunosuppressants (cyclophosphamide, cyclosporine, azathioprine, etc.), or Tripterygium within 4 weeks prior to study entry
- •Chest x-ray abnormalities, such as tuberculosis, interstitial pulmonary fibrosis, etc.
- •ALT >1.5×ULN, AST >1.5×ULN, Cr >135umol/L
- •WBC<4×109/L，HGB<85g/L，PLT<100×109/L
- •Subjects with serious cardiovascular, renal, hematologic or endocrine diseases
- •Pregnant or lactating women
- •Allergic to any of the study drugs
- •History of alcoholism
- •Subjects with mental illness
- •Subjects receiving live vaccines recently
- •Subjects participating in other clinical study within 3 months prior to study entry
研究组 & 干预措施
Iguratimod and MTX combination
Experimental
干预措施: Iguratimod (Drug)
Iguratimod monotherapy
Experimental
干预措施: Iguratimod (Drug)
Iguratimod and MTX combination
Experimental
干预措施: Methotrexate (Drug)
MTX monotherapy
Active Comparator
干预措施: Methotrexate (Drug)
结局指标
主要结局
Percentage of patients with ACR 20 response
时间窗: week 52
Change from baseline in modified Total Sharp Score (mTSS)
时间窗: week 52
次要结局
- Change from baseline in mTSS(week 24)
- Percentage of patients achieving radiographic non-progression(week 24, week 52)
- Percentage of patients with ACR 20 response(week 12, week 24, week 40)
- Percentage of patients with ACR 50 response(week 12, week 24, week 40, week 52)
- Incidence of adverse events(up to 2 years)
- Percentage of patients with Simplified Disease Activity Index (SDAI) ≤ 3.3(week 12, week 24, week 40, week 52)
- Percentage of patients with ACR 70 response(week 12, week 24, week 40, week 52)
- Change from baseline in Health Assessment Questionnaire (HAQ)(week 12, week 24, week 40, week 52)
研究者
研究点 (1)
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