A Prospective Cohort Study to Observe the Difference of Efficacy Between Infliximab With Methotrexate and Classic DMARDs in the Severe Rheumatoid Arthritis Patients With Poor Prognosis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 170
- 试验地点
- 3
- 主要终点
- The rate of subjects achieving DAS<2.6
研究概览
简要总结
A prospective, multi-centric, cohort study to observe the efficacy difference between intensive classic DMARDs and Infliximab(IFX) with methotrexate(MTX) treatment in sever rheumatoid arthritis(RA) 28 joints disease activity score>5.1(DAS28>5.1) patients with poor prognostic factors.Primary objective is compare the difference of clinical remission rate between classic DMARDs and Infliximab with MTX treatment in severe RA patients with poor prognostic factors at week 30.
详细描述
Primary objective is compare the difference of clinical remission rate between classic conventional disease-modifying antirheumatic drugs(DMARDs) and Infliximab with methotrexate(MTX) treatment in severe RA patients with poor prognostic factors at week 30.
Secondary objectives are compare the differences of laboratory measurements, clinical remission rate, function score and imageological evaluation between classic DMARDs and Infliximab with MTX treatment in severe RA patients with poor prognostic factors at week 14, 30, 54 and 102.
Infliximab arm：Infliximab with MTX treatment: Infliximab 3mg/kg at week 0, 2, 6 and then once every 8 weeks, MTX>7.5mg per week. To observe the results at week 14, 30, 54 and 102 after 6 times IFX treatment. It recommended that continue to receiving IFX treatment after remission for a period of time in good economic condition patients while receiving MTX with hydroxychloroquine(HCQ) or leflunomide(LEF) in poor economic condition patients.
Classic DMARDs treatment arm： Classic DMARDs treatment combination of 2 or 3 drugs, 2-drugs combination is MTX with LEF or Thunder God Vine, 3-drugs combination is MTX with HCQ and LEF or Thunder God Vine for total 30 weeks.
Effective dose: MTX: 10-15mg per week; LEF: 20mg per day; HCQ: 200-400 mg per day; Thunder God Vine: 40-60 mg per day; It recommended that the maintain regimen is MTX with HCQ or LEF after remission for a period of time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Able and willing to provide written informed consent and to comply with the study protocol
- •Age is from 18 to 70 years old
- •To accord with the diagnostic criteria of ACR/EULAR 2010 and the course of disease is less than 2 years;
- •Active RA, DAS28 score is above 5.1
- •At least has one poor prognostic factor including:(1)functional limitations,(2)extra-articular manifestation,(3)positive RF or Anti-Cyclic Citrullinated Peptide(CCP) antibody ,(4)X- ray confirmed bone erosion.
排除标准
- •Received Infliximab or other biologics treatment previously;
- •Abnormal liver function, the level of alanine aminotransferase(ALT) and aspartate amino transferase(AST) is higher than 3 times of upper limit of normal (ULN);
- •Renal dysfunction, the level of serum creatinine is higher than 1.5 times of ULN;
- •Receive live virus or bacterial vaccination currently or 4 weeks before recruitment into the study;
- •Previously affected by tuberculosis or with positive tuberculin test result;
- •Has history of lymphoproliferative disease such as lymphoma or suspected lymphoproliferative disease through signs and symptoms such as lymphadenectasis in posterior cervical triangle, interclavicular or supratrochlear, or splenomegaly (more than 2 cm below the ribs);
- •History of multiple sclerosis or other demyelinating diseases of central nervous system;
- •Be allergic to experimental drug or with serious allergic constitution;
- •Malignancies excluding cured skin basal cell carcinoma or carcinoma in situ of cervix;
- •Systemic active infection, HIV infection or active Hepatitis B or Hepatitis B virus carriers;
- •With serious medical diseases such as cardiac insufficiency (), myocardial ischemia, serious arrhythmia, renal insufficiency, serious liver dysfunction, significant hematological system diseases, hypercortisolism, uncontrollable hypertension and diabetes mellitus;
研究组 & 干预措施
Infliximab group
Infliximab with MTX treatment
干预措施: Infliximab group (Drug)
Classic DMARDs treatment group
Classic DMARDs treatment（MTX 、LEF 、HCQ 、 LEF ）
干预措施: Classic DMARDs treatment group (Drug)
结局指标
主要结局
The rate of subjects achieving DAS<2.6
时间窗: at week 30
The rate of subjects achieving DAS\<2.6 at week 30
次要结局
- The rate of subjects achieving DAS<2.6(at week 14, 54 and 102)
- The rate of subjects achieving SDAI<3.3(at week 14, 30, 54 and 102)
- The rate of subjects achieving ACR/EULAR remission(at week 14, 30, 54 and 102)
- MRI score(at week 14, 30, 54 and 102)
- The HAQ score(at week 14, 30, 54 and 102)
- The SHARP score(at week 14, 30, 54 and 102)
- The level of ESR(at week 2, 6, 14, 22, 30, 54 and 102)
- The level of CRP(at week 2, 6, 14, 22, 30, 54 and 102)
研究者
Zhang, Xiao, M.D.
Director
Zhang, Xiao, M.D.