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

May 17, 2026 updated by: Esraa Mohamed Mahmoud, Sohag University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Sohag Governorate
      • Sohag, Sohag Governorate, Egypt, 82524
        • Recruiting
        • Rheumatology and Rehabilitation Department, Faculty of Medicine, Sohag University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

This study will include all patients presenting to the Rheumatology department, Sohag University Hospitals, from February 1st, 2026, till June 30th, 2027, and who were diagnosed with Rheumatoid Arthritis according to the 2010 American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology Classification Criteria for RA .

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Flare group
patients who will have at least one flare of rheumatoid arthritis during the study period
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.
Non-flare group
Patients who will have no flares of rheumatoid arthritis disease during the study period
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Every 3 months for a total of 17 months (from February 2026 to June 2027).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

January 25, 2026

First Submitted That Met QC Criteria

January 25, 2026

First Posted (Actual)

February 2, 2026

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 17, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med--26-1-1MD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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