- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07360340
Methotrexate Therapy and High-Resolution CT Chest and Spirometry Test Findings in Patients With Rheumatoid Arthritis.
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
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Cairo, Egypt
- Faculty of medicine, Ain Shams university
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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HRCT Chest and spirometry test findings in RA Egyptian patients, and their relationship to Methotrexate therapy, disease duration, and activity.
Time Frame: 7 months
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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
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7 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Heba M Shalaby, MD, Ain Shams University, Faculty of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FMASU Ms 778/2022
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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