Persistence of Biological Treatment and Inhibitors of Jak Kinases in Habitual Clinical Practice in Patients With Rheumatoid Arthritis. Influence of the Comorbidities.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 540
- 试验地点
- 1
- 主要终点
- Survival study
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Survival study
时间窗: Up to 60 weeks
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.
次要结局
- Study of clinical characteristics.(Up to 60 weeks)
- Measure of the influence of comorbidities.(Up to 60 weeks)
- Number of participants who discontinued treatment due to serious adverse effects.(Up to 60 weeks)