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Therapeutic Strategy Associated With bDMARDs or tsDMARDs in Rheumatoid Arthritis and Psoriatic Arthritis (STRATEGE2)

2021年10月14日更新者：Nordic Pharma SAS

Therapeutic Strategy Concerning the Drug Management Associated With bDMARDs or tsDMARDs in Rheumatoid Arthritis and Psoriatic Arthritis

This is a longitudinal, observational, prospective, multicentre study conducted in France, among a representative sample of rheumatology doctors.

The aim of this study is to describe in real life the therapeutic strategy when faced with a patient with rheumatoid arthritis (RA) or psoriatic arthritis (PsA) who requires initiation of treatment with biotherapy or targeted therapy. The evolution of the disease and the possible therapeutic adaptations will then be followed for 2 years.

研究概览

地位

主动，不招人

条件

研究类型

观察性的

注册 (预期的)

400

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

法国
- - Paris、法国、75007
    - Nordic Pharma

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

RA or PsA patient undergoing treatment with MTX for at least 3 months and requiring the introduction of a first bDMARD or tsDMARD due to the activity of the disease will be asked to participate from bDMARD or tsDMARD treatment introduction (inclusion visit) up to 24 months after inclusion.

描述

Inclusion Criteria:

Major patient (age ≥ 18 years)
Patient with RA according to American College of Rheumatology (ACR) / European Congress of Rheumatology (EULAR) 2010 or ACR 1987 or patient with PsA according to ClASsification criteria for Psoriatic ARthritis (CASPAR) criteria
Patient undergoing treatment with methotrexate (MTX) (oral or injectable) initiated for at least 3 months.
Naïve patient of biotherapy or tsDMARD and requiring the introduction of a first bDMARD or tsDMARD due to the activity of the disease.
Patient informed and accepting the computer processing of his/her medical data and informed of his/her rights of access and rectification.

Exclusion Criteria:

Patient participating in an interventional study in rheumatology
Patient with axial spondyloarthritis (for patients with PsA)

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

观测模型：队列
时间观点：预期

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
The Primary Outcome Measure is not provided for now to the investigators (and public) in order not to bias the therapeutic strategies. 大体时间：12 months after inclusion	Not provided as Outcome 1 is blinded	12 months after inclusion

次要结果测量

结果测量	措施说明	大体时间
Main criteria analysis 大体时间：24 months after inclusion	Same Outcome 1, but at 24 month. This outcome is blinded too.	24 months after inclusion
Therapeutic adaptations of conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), biologic DMARDs (bDMARDs), targeted synthetic DMARDs (tsDMARDs), Nonsteroidal anti-inflammatory drugs (NSAIDs) and corticosteroids 大体时间：12 and 24 months after inclusion	delays, changes in dosage, changes in the route of administration, reasons for adaptations ...	12 and 24 months after inclusion
Disease outcome 大体时间：12 and 24 months after inclusion	disease activity (Disease Activity Score DAS28 and Disease Activity in PSoriatic Arthritis DAPSA)), percentage of patients in remission, quality of Life (Dermatology Life Quality Index (DLQI))	12 and 24 months after inclusion
Patient adherence to treatment 大体时间：12 and 24 months after inclusion	The variation of patients' adherence to antirheumatic treatments evaluated by the Compliance Questionnaire for Rhumatology (CQR19).	12 and 24 months after inclusion
Fatigue and pain 大体时间：12 and 24 months after inclusion	Visual Analog Scale (VAS) anchored by 2 verbal descriptors, one for each symptom extreme : 0 (no fatigue, no pain) to 10 (maximum fatigue, maximum pain).	12 and 24 months after inclusion
Functional capacity (Health Assessment Questionnaire (HAQ)) 大体时间：12 and 24 months after inclusion	This questionnaire is completed by patients at baseline, 12 months and 24 months.	12 and 24 months after inclusion
Cross-perception (doctor / patient) about participation in the "shared medical decision" 大体时间：12 and 24 months after inclusion	This outcome is based on 2 mirror questions (one asked to the physician and on to the patient). They are asked if the decision to adapt the therapeutic decision is a "shared medical decision". Five answers are possible from "fully" to "not at all".	12 and 24 months after inclusion
Care path at the end of the visit 大体时间：12 and 24 months after inclusion	The physician is asked about the patient pathway (How and by whom the patient will be followed : nurse, other physicians)	12 and 24 months after inclusion

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Nordic Pharma SAS

调查人员

研究主任：Hélène HERMAN-DEMARS, MD、Nordic Pharma
首席研究员：René Marc FLIPO, Prof、CHRU Lille
首席研究员：Cécile GAUJOUX-VIALA, Dr、CHU Nîmes
首席研究员：Emmanuelle DERNIS, Dr、CH Le Mans
首席研究员：Éric SENBEL, Dr、Marseille

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2019年2月25日

初级完成 (预期的)

2021年12月31日

研究完成 (预期的)

2022年12月31日

研究注册日期

首次提交

2019年6月24日

首先提交符合 QC 标准的

2021年10月14日

首次发布 (实际的)

2021年10月19日

研究记录更新

最后更新发布 (实际的)