NCT07381296

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Sohag University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Rheumatoid Arthritis Disease Flare

Interventions

Type	Name	Description
OTHER	Clinical and Laboratory Monitoring for RA Disease Flare	This is an observational study; no new clinical interventions or experimental drugs will be administered. All patients will continue their standard-of-care treatment as prescribed by their treating rheumatologist. The study involves scheduled clinical and laboratory monitoring every three months to identify predictors of rheumatoid arthritis (RA) flares. Data collection includes: Clinical assessments: Joint counts (TJC/SJC), Patient/Evaluator Global Assessments, and disease activity scores (DAS28, SDAI, CDAI). Laboratory monitoring: Complete Blood Count (CBC) to calculate systemic inflammatory indices (NLR, PLR, SII, SIRI, and PIV) and acute phase reactants (ESR, CRP). Radiographic evaluation: Assessment of joint damage using the modified Sharp scoring system.

Timeline

• Start date: 2026-02-01
• Primary completion: 2027-06-01
• Completion: 2027-08-01
• First posted: 2026-02-02
• Last updated: 2026-02-04