Prognostic Factors and Predictors of Disease Flare in Patients With Rheumatoid Arthritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Clinical and Laboratory Monitoring for RA Disease Flare.
- Who it may be relevant to
- Registry conditions: Rheumatoid Arthritis Disease Flare. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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 (DA
Primary outcome measures
- Correlation between Systemic Inflammation Ratios and Disease Flares [Time frame: Every 3 months for a total of 17 months (from February 2026 to June 2027).]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Egypt · 1 center
- Rheumatology and Rehabilitation Department, Faculty of Medicine, Sohag University — Sohag
Identifiers
NCT: NCT07381296 · Soh-Med--26-1-1MD