Methotrexate Therapy and High-Resolution CT Chest and Spirometry Test Findings in Patients With Rheumatoid Arthritis.

January 14, 2026 updated by: Ain Shams University

Methotrexate Therapy and High-Resolution CT Chest and Spirometry Test Findings in Egyptian Patients With Rheumatoid Arthritis.

ABSTRACT Background: Rheumatoid arthritis (RA) is characterized by symmetrical erosive synovitis and progressive disability, often complicated by extra-articular manifestations especially in seropositive patients, among them, lung involvement is common, and it can include a wide spectrum of disorders, ranging from airways, pleural disease, bronchiectasis, lung nodules, to infection.

Aim of the Work: The aim of this study is to assess HRCT Chest and spirometry test findings in RA Egyptian patients, and their relationship to Methotrexate therapy, disease duration, and activity.

Patients and Methods: This was a cross sectional study which was done on 50 RA patients diagnosed according to Rheumatoid Arthritis - 2010 American college of rheumatology/ European League Against Rheumatism (ACR-EULAR) attending rheumatology and chest inpatient departments and outpatient clinics in Ain Shams University Hospitals.

Results: Patients were divided into two equal groups: Group A: - 25 RA patients treated with MTX only +/- low dose steroid. Group B: - 25 MTX naive RA patients (treated with DMARDs other than MTX) +/- low dose steroid.

Conclusion: We found MTX has no role in RA-ILD, there is no significant difference between MTX users and MTX naïve regarding spirometry and HR-CT.

Study Overview

Status

Completed

Detailed Description

This was a cross-sectional study which was done on 50 RA patients diagnosed according to Rheumatoid Arthritis - 2010 American college of rheumatology/ European League Against Rheumatism (ACR-EULAR) classification criteria (Aletaha et al., 2010), patients enrolled from rheumatology and chest inpatient departments and outpatient clinics in Ain Shams University Hospitals.

Patients were divided in to two equal groups:

- Group A: - 25 RA patients treated with MTX only +/- low dose steroid

. Group B: - 25 MTX naive RA patients (treated with DMARDs other than MTX) +/- low dose steroid.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

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

Study Locations

      • Cairo, Egypt
        • Faculty of medicine, Ain Shams university

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

No

Sampling Method

Non-Probability Sample

Study Population

50 RA patients diagnosed according to Rheumatoid Arthritis - 2010 American college of rheumatology/ European League Against Rheumatism (ACR-EULAR) attending rheumatology and chest inpatient departments and outpatient clinics in Ain Shams University Hospitals.

Description

Inclusion Criteria:

  • Age more than 18 yr rheumatoid arthritis more than one year, all patients were under RA Treatment for more than one year

Exclusion Criteria:

  • Patients with recent respiratory infection, history of pulmonary tuberculosis or other chest disorders such as COPD, bronchial asthma, vasculitis, pleural diseases, thromboembolism or pulmonary hypertension, any patient receiving drugs that induce ILD such as chemotherapeutics, antimicrobials, cardiovascular agents.

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
Group A 25 patients on methotrexate therapy, Group B 25 patients not on methotrexate
Group A: - 25 RA patients treated with MTX only +/- low dose steroid. Group B: - 25 MTX naive RA patients (treated with DMARDs other than MTX) +/- low dose steroid.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HRCT Chest and spirometry test findings in RA Egyptian patients, and their relationship to Methotrexate therapy, disease duration, and activity.
Time Frame: 7 months
50 RA patients diagnosed according to Rheumatoid Arthritis - 2010 American college of rheumatology/ European League Against Rheumatism (ACR-EULAR) classification criteria (Aletaha et al., 2010), patients enrolled from rheumatology and chest inpatient departments and outpatient clinics in Ain Shams University Hospitals, and had spirometry, HRCT chest to assess methotrexate pulmonary afffection
7 months

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Heba M Shalaby, MD, Ain Shams University, Faculty of Medicine

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)

December 1, 2022

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

July 31, 2023

Study Registration Dates

First Submitted

January 1, 2026

First Submitted That Met QC Criteria

January 14, 2026

First Posted (Actual)

January 22, 2026

Study Record Updates

Last Update Posted (Actual)

January 22, 2026

Last Update Submitted That Met QC Criteria

January 14, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

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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