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临床试验/NCT07381296
NCT07381296招募中不适用

Prognostic Factors and Predictors of Disease Flare in Patients With Rheumatoid Arthritis

Sohag University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2026年2月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
Correlation between Systemic Inflammation Ratios and Disease Flares

研究概览

简要总结

The goal of this observational study is to help find better ways to predict when a flare of your disease (rheumatoid arthritis) might happen. By looking at your registered data, symptoms, disease characteristics, and specific markers in your blood, the investigators hope to help doctors make better decisions about your treatment in the future. The main question it aims to answer is:

Can specific patient data, disease characteristics, drug history, or markers in a patient's blood be used to predict when a rheumatoid arthritis flare is about to happen? Participants already diagnosed with rheumatoid arthritis and who have their disease controlled will be followed up every 3 months for any signs or symptoms of a flare.

详细描述

Rheumatoid Arthritis (RA) is a chronic autoimmune condition requiring a "treat-to-target" approach to prevent irreversible joint damage and functional disability. While modern therapeutic strategies have increased the number of patients achieving remission or low disease activity (LDA), approximately 30% of these patients experience disease flares. These flares are associated with physical impairment, reduced quality of life, and radiographic progression.Predicting these flares remains a significant clinical challenge due to their sporadic nature. This study will monitor a cohort of RA patients over a 17-month period.

Methodology and Observations:

Participants will undergo comprehensive evaluations every three months. The study will focus on two main categories of predictors: Clinical and Radiographic Predictors: the investigators will analyze disease duration, time to achieve remission, medication adherence, and baseline radiographic damage (using the modified Sharp scoring system). Inflammatory Biomarkers: A core focus of the study is the evaluation of inexpensive, readily available blood-cell-derived indices. These indices are calculated from complete blood counts (CBC) and include:

NLR: Neutrophil/Lymphocyte Ratio PLR: Platelet/Lymphocyte Ratio SII: Systemic Immune-inflammation Index SIRI: Systemic Inflammation Response Index PIV: Pan-Immune-Inflammation Value A "flare" is defined using standardized DAS28 criteria (an increase in DAS28 > 1.2, or > 0.6 if the concurrent DAS28 is ≥ 3.2). The study will correlate the fluctuations in the inflammatory indices mentioned above with the occurrence, duration, and frequency of these flares. The findings are intended to validate whether all data collected and/or these blood-cell-derived markers can serve as reliable, cost-effective tools for monitoring RA disease activity and predicting a flare.

研究设计

研究类型
Observational
观察模型
Cohort
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

入选标准

  • Age: patients >18 years old.
  • Patients with rheumatoid arthritis diagnosed according to the 2010 American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology Classification Criteria for RA.
  • Clinical remission or low disease activity according to the disease activity score in 28 joints (DAS28).

排除标准

  • Age < 18 years.
  • Any autoimmune disease other than Rheumatoid arthritis. Severe infection, pregnancy, and malignancy.

研究组 & 干预措施

Flare group

patients who will have at least one flare of rheumatoid arthritis during the study period

干预措施: Clinical and Laboratory Monitoring for RA Disease Flare (Other)

Non-flare group

Patients who will have no flares of rheumatoid arthritis disease during the study period

干预措施: Clinical and Laboratory Monitoring for RA Disease Flare (Other)

结局指标

主要结局

Correlation between Systemic Inflammation Ratios and Disease Flares

时间窗: Every 3 months for a total of 17 months (from February 2026 to June 2027).

Evaluation of blood-cell-derived inflammatory indices including Neutrophil/Lymphocyte Ratio (NLR), Systemic Immune-inflammation Index (SII), and Pan-Immune-Inflammation Value (PIV). These will be calculated from CBC results to determine their sensitivity and specificity in predicting a clinical flare.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Esraa Mohamed Mahmoud

Dr.

Sohag University

研究点 (1)

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