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临床试验/NCT04470453
NCT04470453终止4 期

Association Between Methotrexate Erythrocyte Polyglutamate Concentration and Biological Drug Concentration and Clinical Response in Rheumatoid Arthritis Patients Treated With Subcutaneous Injectable Methotrexate and a First Biological Drug

Centre Hospitalier Universitaire de Saint Etienne1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2020年10月8日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
入组人数
16
试验地点
1
主要终点
MTX-PG concentration

研究概览

简要总结

The combination of methotrexate (MTX) with a biological disease-modifying antirheumatic drugs (bDMARD) is the next step in treatment with MTX monotherapy in rheumatoid arthritis (RA). Estimation of MTX and bDMARD impregnation could be performed with the erythrocyte MTX polyglutamate (MTX-PG) and bDMARD assays before to move to a second bDMARD. In RA patients treated with MTX (prescribed for at least 6 months at a stable dose for at least 3 months) in combination to a first bDMARD (prescribed since at least 3 months), an assay of MTX-PG and bDMARD will be performed in tow subsets of RA according to the level of disease activity. The first subset is active RA defined by a DAS28 (disease activity score 28)>3.2. The second one is RA in clinical remission defined by a DAS28<2.6. The main hypothesis is the association between the low concentration of MTX-PG and the clinical response of RA patients treated with subcutaneous methotrexate injection associated to a first bDMARD. Adherence to MTX will be reviewed by the Compliance Questionnaire Rheumatology (CQR) questionnaire. This assay could be useful to improve MTX management before to move to a second bDMARD.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age > 18 years and have social security affiliation.
  • Patients followed in the Rheumatology Department at the hospital of St Etienne.
  • Rheumatoid Arthritis patients in remission (Disease Activity Score 28<2.6) with methotrexate (MTX) treatment for at least 6months, and with a stable dose for 3months.
  • Patients with a High Disease Activity Rheumatoid Arthritis activity (Disease Activity Score 28>3.2) with methotrexate (MTX) treatment (≥ 15 mg/week), taking MTX treatment for at least 6months with a stable subcutaneous weekly MTX injection (≥ 15 mg/week) treatment during the previous 3 months.
  • Signed informed consent.

排除标准

  • Patients treated with another conventional synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARD)
  • Another diagnostic than rheumatoid arthritis

研究组 & 干预措施

Patients with active rheumatoid arthritis

Experimental

30 patients with active rheumatoid arthritis will be included. They will have a blood sample and Compliance Rheumatology Questionnaire (CRQ).

干预措施: Blood sample (Biological)

Patients with active rheumatoid arthritis

Experimental

30 patients with active rheumatoid arthritis will be included. They will have a blood sample and Compliance Rheumatology Questionnaire (CRQ).

干预措施: CRQ (Diagnostic Test)

Patients with rheumatoid arthritis into remission

Experimental

30 patients with rheumatoid arthritis into remission will be included. They will have a blood sample and Compliance Rheumatology Questionnaire (CRQ).

干预措施: Blood sample (Biological)

Patients with rheumatoid arthritis into remission

Experimental

30 patients with rheumatoid arthritis into remission will be included. They will have a blood sample and Compliance Rheumatology Questionnaire (CRQ).

干预措施: CRQ (Diagnostic Test)

结局指标

主要结局

MTX-PG concentration

时间窗: Hour 1

To compare MTX-PG concentration in patients with active rheumatoid arthritis and patients with rheumatoid arthritis in remission

次要结局

  • metabolites dosing of MTX-PG (nmol/l)(Hour 1)
  • Analysis of CQR score response(Hour 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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