Persistence of Biological Treatment and Inhibitors of Jak Kinases in Patients With Rheumatoid Arthritis. (Arthritis)
Persistence of Biological Treatment and Inhibitors of Jak Kinases in Habitual Clinical Practice in Patients With Rheumatoid Arthritis. Influence of the Comorbidities.
One-center observational study aimed at determining the survival of patients with rheumatoid arthritis treated with targeted synthetic disease-modifying drugs (FAMEsd) and biologic disease-modifying drugs (FAMEb).
These patients will be administered a series of medications and a follow-up will be carried out to analyze their evolution.
研究概览
地位
条件
详细说明
One-center observational study aimed at determining the survival of patients with rheumatoid arthritis treated with targeted synthetic disease-modifying drugs (FAMEsd) and biologic disease-modifying drugs (FAMEb).
The drugs to be administered to patients are:
- JAK-type kinase inhibitors.
- Monoclonal antibodies against TNF.
- Soluble receptor against TNF.
- Biosimilar FAMEb.
- Rituximab.
- Abatacept.
- Drugs that block IL6.
A follow-up will be carried out at 12, 24, 48, 60, 72 and 84 months from the start of treatment, to analyze how the patient's health improves.
研究类型
注册 (预期的)
联系人和位置
学习联系方式
- 姓名：Carlos García Pérez
- 电话号码：955 04 31 27
- 邮箱：administración.eecc.hvm.sspa@juntadeandalucia.es
研究联系人备份
- 姓名：Blanca Estela Hernández Cruz
- 电话号码：955008000
- 邮箱：blancahcruz@gmail.com
学习地点
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Sevilla、西班牙、41009
- 招聘中
- Hospital Universitario Virgen Macarena
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接触：
- Blanca Estela Hernández Cruz
- 电话号码：955008000
- 邮箱：blancahcruz@gmail.com
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Patients aged ≥18 years.
- With a diagnosis of Adult Rheumatoid Arthritis according to the 2010 ACR / EULAR criteria.
- Who have received at least one of the doses of the study drugs.
- In follow-up in the consultations of the UGC of Rheumatology of the HUVM.
- With at least two complete evaluations (baseline and final) of clinical variables.
Exclusion Criteria:
- Patients where the medical records lack sufficient baseline and final variables to perform the analysis.
- Patients in whom more than 50% of the variables to be collected are missing in the data collection.
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
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Cases 1
Patients treated with JAK-type kinase inhibitors.
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Cases 2
Patients treated with monoclonal antibodies against TNF.
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Cases 3
Patients treated with soluble receptor against TNF.
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Cases 4
Patients treated with FAME group biosimilars.
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Cases 5
Patients treated with rituximab.
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Cases 6
Patients treated with abatacept.
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Cases 7
Patients treated with drugs that block the IL6.
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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 |
|---|---|---|
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Survival study
大体时间：Up to 60 weeks
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To know the survival at 12, 24, 48, 60, 72 and 84 months to the synthetic directed anti-rheumatic drugs, disease modifiers (FAMEsd) and the biological disease modifying anti-rheumatic drugs (FAMEb) in patients with rheumatoid arthritis treated in routine.
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Up to 60 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Study of clinical characteristics.
大体时间：Up to 60 weeks
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To know the sociodemographic and clinical characteristics of the patients who receive FAMEsd and FAMEb in routine clinical practice at the HUVM.
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Up to 60 weeks
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Measure of the influence of comorbidities.
大体时间：Up to 60 weeks
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To assess the influence of comorbidities on drug persistence.
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Up to 60 weeks
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Number of participants who discontinued treatment due to serious adverse effects.
大体时间：Up to 60 weeks
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Failure due to serious adverse events, adverse events of special interest, emerging adverse events and minor adverse events that require discontinuation of the drug.
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Up to 60 weeks
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合作者和调查者
调查人员
- 首席研究员：Blanca Estela Hernández Cruz、Hospital Universitario Virgen Macarena
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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