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

Sohag University

Status: Not yet enrolling

Conditions: Rheumatoid Arthritis Disease Flare

Treatments: Other: Clinical and Laboratory Monitoring for RA Disease Flare

Study type: Observational

Funder types: Other

Identifiers

NCT07381296

Soh-Med--26-1-1MD

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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).

Exclusion criteria

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

Trial design

200 participants in 2 patient groups

Flare group

Description:

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

Treatment:

Other: Clinical and Laboratory Monitoring for RA Disease Flare

Non-flare group

Description:

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

Treatment:

Other: Clinical and Laboratory Monitoring for RA Disease Flare