NCT00901550已完成不适用
The Chinese University of Hong Kong Early Arthritis Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Changes in the volume of enhancing synovitis measured by Magnetic Resonance Imaging(MRI) as it corresponds to active, inflamed tissue and is therefore expected to be a better marker of disease activity.
研究概览
简要总结
The purpose of this study is:
- To ascertain whether the quantitative assessment of enhancing synovial volume and perfusion indices on serial Magnetic Resonance Imaging (MRI) examination are useful indicators of responsiveness to treatment in early Rheumatoid Arthritis (RA) using biologic therapy and Methotrexate (MTX) compared with Methotrexate(MTX) alone.
- To assess the cost-effectiveness of Tumor Necrosis Factor (TNF) blockers compared with Methotrexate(MTX) monotherapy for Rheumatoid Arthritis(RA).
详细描述
This was a 24-week open-label randomized study. Forty patients are randomly assigned to receive either combination infliximab plus Methotrexate(MTX) (n=20) or Methotrexate(MTX) alone (n=20)
All participants received oral Methotrexate(MTX), starting at 7.5 mg/week. In patients with persistent tender or swollen joints, the dose was escalated in a graduated manner (2.5 mg/week every 1-2 weeks) to 15 mg/week by week 4 or 20 mg/week by week 8 Patients in combination group receive infliximab 3mg/kg at weeks 0, 2, and 6 and every 8 week thereafter. Comprehensive assessment will be made on week 0, 12, 24.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women, 18 years of age or older
- •Clinical diagnosis of RA with a duration not more than 24 months (Fulfilled the 1987 American College of Rheumatology (ACR) criteria for RA)
- •Patients at risk of developing persistent or erosive arthritis
- •DAS 28 ≥ 3.2
- •Prednisolone < 10mg/day and started at least 4 weeks before baseline
- •Either has ESR ≥ 28, CRP ≥ 10, presence of rheumatoid factor or anti-CCP, present of HLADRB*0401 or DRB1*0404, and radiographic erosions
- •Informed consent
排除标准
- •Little or no ability for self-care
- •Previous treatment with DMARDs other than antimalarials
- •Concomitant treatment with an experimental drug
- •Malignancy within the last 5 years
- •Bone marrow hypoplasia
- •Clinically significant renal disease ( serum creatinine level ≥ 150µmol/L) or estimated creatinine clearance > 75ml/min, alanine aminotransferase (ALT) exceeds the upper limit of normal
- •History of any clinically significant adverse reaction to murine or chimeric proteins
- •History of TB in the last 5 years
- •Known to have hepatitis B, or hepatitis C
- •Had an opportunistic infection (e.g. herpes zoster, cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) within 6 months before screening
- •History or ongoing chronic or recurrent disease; renal infection, chest infection, urinary tract infection, ulcer or skin wound
- •History of infected joint prosthesis and use of antibiotics for the joint
- •Received intravenous antibiotics within 30 days or oral antibiotics within 14 days for screening
- •History of known demyelinating diseases (multiple sclerosis or optic neuritis)
- •Current signs or symptoms of severe diseases (renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic, etc)
- •History or concurrent CHF
- •History of lymphoproliferative disease, splenomegaly
- •Female of childbearing potential, unwilling to use adequate contraception during the study
- •Current or recent ( within the past 3 months) pregnancy and cancer
- •Active smoker, alcohol or drug abuse
研究组 & 干预措施
Methotrexate
Active Comparator
A drug for RA patient
干预措施: Methotrexate (Drug)
Infliximab
Active Comparator
for RA treatment
干预措施: Infliximab (Drug)
结局指标
主要结局
Changes in the volume of enhancing synovitis measured by Magnetic Resonance Imaging(MRI) as it corresponds to active, inflamed tissue and is therefore expected to be a better marker of disease activity.
时间窗: week 24
次要结局
- changes in the synovitis grading and the perfusion indices(24 week)
- proportion of patients achieving ACR and EULAR responses(week 24)
- Correlation between the Magnetic Resonance Imaging(MRI) findings and changes on x-ray(week 24)
研究者
Lai-Shan Tam
Professor
Chinese University of Hong Kong
研究点 (3)
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