The Clinical Study to Observe the Efficacy and Safety of Immunomodulators in Rheumatoid Arthritis Patients for 6 Months Treatment in China
概览
- 阶段
- 4 期
- 干预措施
- Iguratimod
- 疾病 / 适应症
- Arthritis, Rheumatoid
- 发起方
- Qilu Hospital of Shandong University
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- The percentage of patients who achieve clinical remission using European League Against Rheumatism (EULAR) response criteria DAS28.
- 状态
- 招募中
- 最后更新
- 3年前
概览
简要总结
This study includes naive patients and csDMARDs-IR RA patients, treated with different regimens such as Iguratimod combination of different csDMARDs, or csDMARD with TNF inhibitors for 24 weeks. The disease activity and drug response will be observed. The immune disorder and synovial function will be evaluated at the same time.
详细描述
In this study cohorts, naïve or csDMARDs-IR patients are treated with different csDMARDs combination or TNF inhibitors for 24 weeks to get remission in clinical. The biomarkers in their plasma and synovial fluid and tissue specimens from RA patients are screened to predict the efficacy of specific treatment.
研究者
Qiang Shu
Chief Physician
Qilu Hospital of Shandong University
入排标准
入选标准
- •1.Patients with RA who meet ACR 1987 rheumatoid arthritis classification criteria or ACR/EULAR 2010 rheumatoid arthritis Classification Criteria and have knee dysfunction.
- •ACR 1987 rheumatoid arthritis classification criteria
- •morning stiffness lasting at least 1 hour (≥6w)
- •there are 3 or more joint areas swollen (≥6w)
- •swelling of the wrist, metacarpophalangeal, and proximal phalangeal joint areas (≥6w)
- •symmetrical arthrogryposis (≥6w)
- •hand x-ray changes (at least osteoporosis and joint space narrowing)
- •positive rheumatoid factor (titer \> 1:32) RA can be diagnosed by meeting 4 of the above 7 items
- •ACR/EULAR 2010 rheumatoid arthritis Classification Criteria
- •Involved joints
排除标准
- •Patients with combined active hepatitis
- •Patients with active tuberculosis
- •Patients withinfection and malignancy
研究组 & 干预措施
Methotrexate(MTX)+Iguratimod(IGU)
Drug: Iguratimod（IGU），25mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response. Drug: Methotrexate(MTX)，10mg, po, quaque week (qw) prescribed at the beginning and adjusted due to patient response. For RA patients with naive or csDMARDs-IR
干预措施: Iguratimod
Methotrexate(MTX)+Iguratimod(IGU)
Drug: Iguratimod（IGU），25mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response. Drug: Methotrexate(MTX)，10mg, po, quaque week (qw) prescribed at the beginning and adjusted due to patient response. For RA patients with naive or csDMARDs-IR
干预措施: Methotrexate
Adalimumab+Methotrexate(MTX)
Drug: Adalimumab，40mg, iH,q2w, once two weeks (q2w) prescribed at the beginning and adjusted due to patient response. Drug: Methotrexate(MTX)，7-10mg, po, quaque week (qw) prescribed at the beginning and adjusted due to patient response. For RA patients with csDMARDs-IR
干预措施: Methotrexate
Adalimumab+Methotrexate(MTX)
Drug: Adalimumab，40mg, iH,q2w, once two weeks (q2w) prescribed at the beginning and adjusted due to patient response. Drug: Methotrexate(MTX)，7-10mg, po, quaque week (qw) prescribed at the beginning and adjusted due to patient response. For RA patients with csDMARDs-IR
干预措施: Adalimumab Injection
Iguratimod(IGU)+Leflunomide(LEF)+Hydroxychloroquine(HCQ)
Drug: Iguratimod（IGU），25mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response. Drug: Leflunomide(LEF)，20mg, po, quaque day (qd) prescribed at the beginning and adjusted due to patient response. Drug: Hydroxychloroquine(HCQ)，200mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response. For RA patients with csDMARDs-IR
干预措施: Iguratimod
Iguratimod(IGU)+Leflunomide(LEF)+Hydroxychloroquine(HCQ)
Drug: Iguratimod（IGU），25mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response. Drug: Leflunomide(LEF)，20mg, po, quaque day (qd) prescribed at the beginning and adjusted due to patient response. Drug: Hydroxychloroquine(HCQ)，200mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response. For RA patients with csDMARDs-IR
干预措施: Leflunomide
Iguratimod(IGU)+Leflunomide(LEF)+Hydroxychloroquine(HCQ)
Drug: Iguratimod（IGU），25mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response. Drug: Leflunomide(LEF)，20mg, po, quaque day (qd) prescribed at the beginning and adjusted due to patient response. Drug: Hydroxychloroquine(HCQ)，200mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response. For RA patients with csDMARDs-IR
干预措施: Hydroxychloroquine
结局指标
主要结局
The percentage of patients who achieve clinical remission 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
- Percentage of Disease Activity Score 28 (DAS28) -ESR Criteria Responders(baseline,week 12,week 24)
- Change from baseline Simplified Disease Activity Index (SDAI)(up to week 24)
- Change from baseline Clinical Disease Activity Index (CDAI)(up to week 24)
- Incidence of participant withdrawal(up to week 24)
- Percentage of participants achieving ACR/EULAR remission(week 12,week 24)
- Change From Baseline in Erythrocyte Sedimentation Rate (ESR)(up to week 24)
- Percentage of American College of Rheumatology [ACR] 20、 [ACR]50、 [ACR]70 Criteria Responders every time(up to week 24)
- The percentage of patients who achieve clinical remission using DAS28-ESR.(week 12)
- Change From Baseline in C-reactive Protein (CRP)(up to week 24)
- Change from baseline Health Assessment Questionnaire Disability Index (HAQ-DI)(up to week 24)
- Number of participants with"adverse events (AEs)"(up to week 24)