Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07381296

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rheumatology and Rehabilitation Department, Faculty of Medicine, Sohag University

Sohag, Sohag Governorate, 82524, Egypt

Location status: Recruiting

Location contact

Esraa Mohamed Mahmoud Sayed

CONTACT

[email protected]

01016090864

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clinical and Laboratory Monitoring for RA Disease Flare

Other

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.

Primary outcomes

  1. 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).

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Esraa Mohamed Mahmoud Sayed

CONTACT

[email protected]

+2 01016090864

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 2, 2026
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.