NCT02275299Unknown4 期
A Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Iguratimod or Leflunomide in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Percentage of patients with ACR 20 response and Change in Disease Activity as measured by the DAS28
研究概览
简要总结
This study is intended to evaluate the efficacy and safety of Iguratimod Plus Methotrexate Compared to Leflunomid Plus Methotrexate in patients with active 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 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 more than 3 months from the time of the initial diagnosis
- •Functional Class II-III
- •Subjects have active RA at the time of screening
- •Subjects with inadequate response to biologics should have a washout period before the initiation of study. For etanercept, washout period should be 2-week, and 8-week for infliximab and adalimumab.
- •For firstly diagnostic RA patients, the disease activity should be moderate to severe, with DAS28>3.2
- •Must have at least 4 tender joints (66 join count) and 8 swollen joints( 68 join count) at screening and baseline
- •Has a C-reactive protein ≥ 10 mg/L(or 1.0 mg/dL) OR Erythrocyte Sedimentation Rate (ESR) ≥ 28 mm/hr
- •Must have a negative Pregnancy test and use adequate method of contraception throughout the trial
- •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
- •Subjects have been treated with iguratimod or leflunomide combined with MTX before screening.
- •Subjects combined with other autoimmune disease, such as systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), scleriasis and polymyositis, except for Sjögren syndrome.
- •Chest x-ray abnormalities, such as tuberculosis, interstitial pulmonary fibrosis, etc.
- •ALT >1.5×ULN, AST >1.5×ULN, Cr >135umol/L, total bilirubin>1.5×ULN
- •WBC<4×109/L，HGB<85g/L，PLT<100×109/L
- •Subjects with serious cardiovascular, renal, hematologic, endocrine diseases or malignant
- •Women of Pregnant or breastfeeding, and male or female with recent plan to conception
- •Subjects with immunodeficiency, uncontrolled infection and active gastrointestinal disease
- •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
Drug:Iguratimod 25 mg/tablet, taken orally, 2 tablets/day (bid) Drug:MTX 2.5 mg/tablet, taken orally once a week, 4 tablets/week
干预措施: Iguratimod (Drug)
Iguratimod and MTX combination
Experimental
Drug:Iguratimod 25 mg/tablet, taken orally, 2 tablets/day (bid) Drug:MTX 2.5 mg/tablet, taken orally once a week, 4 tablets/week
干预措施: Methotrexate (Drug)
Leflunomide and MTX combination
Active Comparator
Drug: Leflunomide 10 mg/tablet, taken orally, 2 tablets/day (bid) Drug: Methotrexate 2.5 mg/tablet, taken orally once a week, 4 tablets/week
干预措施: Leflunomide (Drug)
Leflunomide and MTX combination
Active Comparator
Drug: Leflunomide 10 mg/tablet, taken orally, 2 tablets/day (bid) Drug: Methotrexate 2.5 mg/tablet, taken orally once a week, 4 tablets/week
干预措施: Methotrexate (Drug)
结局指标
主要结局
Percentage of patients with ACR 20 response and Change in Disease Activity as measured by the DAS28
时间窗: week 52
次要结局
- Change from baseline in modified Total Sharp Score (mTSS)(week 52)
- Change from baseline in number of swollen and tender joins, Erythrocyte sedimentation rate (ESR) ,C-reactive protein (CRP),anti-citrullinated-protein antibody (ACPA) and heumatoid factor(RF)(week 24, week 52)
- Time to achieve the ACR20, ACR50 and ACR70(week 12, week 24, week 40, week 52)
- Percentage of patients with Simplified Disease Activity Index (SDAI) ≤ 3.3 and change from baseline in Health Assessment Questionnaire (HAQ)(week 12, week 24, week 40, week 52)
- Percentage of patients with ACR 50 response and ACR70 response(week 24,week 52)
- Incidence of adverse events(up to 52 weeks)
研究者
研究点 (1)
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