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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07381296
Enrollment
200
Registered
2026-02-02
Start date
2026-02-01
Completion date
2027-08-01
Last updated
2026-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis Disease Flare

Keywords

rheumatoid arthritis, flare

Brief 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.

Interventions

OTHERClinical 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.

Sponsors

Sohag University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Correlation between Systemic Inflammation Ratios and Disease FlaresEvery 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.

Countries

Egypt

Contacts

CONTACTEsraa Mohamed Mahmoud Sayed
esraamahmoud@med.sohag.edu.eg+2 01016090864

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 20, 2026