The Chinese University of Hong Kong Early Arthritis Study
关键词
抽象
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.
日期
| 最后验证: | 06/30/2012 |
| 首次提交: | 05/12/2009 |
| 提交的预估入学人数: | 05/12/2009 |
| 首次发布: | 05/13/2009 |
| 上次提交的更新: | 07/30/2012 |
| 最近更新发布: | 08/01/2012 |
| 实际学习开始日期: | 10/31/2008 |
| 预计主要完成日期: | 09/30/2011 |
| 预计完成日期: | 09/30/2011 |
状况或疾病
干预/治疗
Drug: Methotrexate
Drug: Infliximab
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Active Comparator: Methotrexate A drug for RA patient | Drug: Methotrexate 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 |
| Active Comparator: Infliximab for RA treatment | Drug: Infliximab Patients in combination group receive infliximab 3mg/kg at weeks 0, 2, and 6 and every 8 week thereafter. |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
结果
主要结果指标
1. 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. [week 24]
次要成果指标
1. changes in the synovitis grading and the perfusion indices [24 week]
2. proportion of patients achieving ACR and EULAR responses [week 24]
3. Correlation between the Magnetic Resonance Imaging(MRI) findings and changes on x-ray [week 24]
