A Randomized, Double-blind Study to Evaluate the Efficacy of Iguratimod Versus Placebo in Patients With Rheumatoid Arthritis on Magnetic Resonance Imaging (MRI)
试验速览
- 阶段
- 4 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in Disease Activity as measured by the DAS28
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of Iguratimod versus placebo on synovial inflammation,bone erosion and bone edema as measured by MRI of wrist and Metacarpophalangeal joints in patients with early Rheumatoid Arthritis (RA).
详细描述
Magnetic resonance imaging (MRI) is a powerful imaging modality that is now widely used in both scientific research and clinical settings to visualise joints of patients with RA. MRI is able to image structural damage and soft tissue changes, ie, synovitis, bone oedema, damage to cartilage and bone, as well as tendon pathology. MRI is more responsive to change in joint damage and can be used to monitor disease progression.
In this studly,MRI of the dominant wrist was performed at baseline ,24 weeks and at 52 weeks, using a 1.5T or 3.0T MRI with a dedicated high-resolution wrist phased array coil.The same scanner and wrist coil were used for three examinations. The hand was placed in the wrist coil at the patient's side with the coil anchored to the base tray to reduce motion artefacts. The MRI sequences in this study included the OMERACT recommended MRI core set of sequences.
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
- •Functional Class II-III
- •Subjects have active RA at the time of screening
- •Must have a negative Pregnancy test and use adequate method of contraception throughout the trial
- •Must have at least 4 tender joints and 4 swollen joints(involved in DAS28) and among these,at least one swollen Metacarpophalangeal joint is essential
- •Has a C-reactive protein ≥ 10 mg/L OR Erythrocyte Sedimentation Rate (ESR) ≥ 28 mm/hr
- •Written informed consent
排除标准
- •Preceding treatment with DMARDs, immunosuppressants (cyclophosphamide, cyclosporine, azathioprine, etc.), biological agents or tripterygium within 12 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 or Cr >1.5mg
- •WBC<4×109/L，HGB<85g/L，PLT<100×109/L
- •Subjects with serious cardiovascular, renal, hematologic,endocrine diseases or malignant
- •Subjects with immunodeficiency, uncontrolled infection and active gastrointestinal disease
- •Pregnant, intend to become pregnant, or are breastfeeding
- •Subjects with other rheumatological diseases such as SLE, mixed connective tissue disease, scleroderma, polymyositis, etc
- •Subjects with inflammatory arthritis, such as gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease
- •Subjects with intra-articular corticosteroid injections within 6 weeks prior to study entry
- •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
Iguratimod:25 mg/tablet, taken orally, 2 tablets/day (bid),52week
干预措施: Iguratimod (Drug)
Iguratimod placebo
Iguratimod placebo:25 mg/tablet, taken orally, 2 tablets/day (bid),24week;Iguratimod:25 mg/tablet, taken orally, 2 tablets/day (bid),28week
干预措施: Iguratimod placebo (Drug)
结局指标
主要结局
Change in Disease Activity as measured by the DAS28
时间窗: week 52
Change from baseline in modified Total Sharp Score (mTSS)
时间窗: week 52
Change from baseline in RA magnetic resonance imaging scoring system (RAMRIS)
时间窗: week 52
Percentage of patients with ACR 20 response
时间窗: week 52
次要结局
- Percentage of patients with ACR 70 response(week 10, week 24, week 40, week 52)
- Change from baseline in RAMRIS(week 24)
- Change from baseline in Disease Activity Score 28 (DAS28)(: week 10, week 24, week 40)
- Percentage of patients with ACR 50 response(week 10, week 24, week 40, week 52)
- Percentage of patients with Simplified Disease Activity Index (SDAI) ≤ 3.3(week 10, week 24, week 40, week 52)
- Change from baseline in Health Assessment Questionnaire (HAQ)(week 10, week 24, week 40, week 52)
- Change from baseline in mTSS(week 24)
- Percentage of patients with ACR 20 response(week 10, week 24, week 40)
- Change from baseline in Simplified Disease Activity Index (SDAI)(week 10, week 24, week 40, week 52)