Methohexitone Pulmonary Adverse ReactionNCT07360340
Methotrexate Therapy and High-Resolution CT Chest and Spirometry Test Findings in Patients With Rheumatoid Arthritis.
An observational study of Methohexitone Pulmonary Adverse Reaction, run by Ain Shams University at 1 site in Egypt.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Methohexitone Pulmonary Adverse Reaction
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2022to 31 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age more than 18 yr rheumatoid arthritis more than one year, all patients were under RA Treatment for more than one year
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Methohexitone Pulmonary Adverse Reaction
- Keywords
- Methotrexate Therapy,, CT Chest, Spirometry Test, Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
HRCT Chest and spirometry test findings in RA Egyptian patients, and their relationship to Methotrexate therapy, disease duration, and activity.
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
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start1 Dec 2022
- Primary completion30 Jun 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methohexitone Pulmonary Adverse ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heba M Shalaby, MD, Principal investigator, Ain Shams University, Faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07360340
- Sponsor's protocol ID
- FMASU Ms 778/2022
- Status last verified
- Dec 2025
- First submitted
- 1 Jan 2026
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methotrexate Therapy and High-Resolution CT Chest and Spirometry Test Findings in Egyptian Patients With Rheumatoid Arthritis.
- ClinicalTrials.gov ID
- NCT07360340
- Acronym / sponsor ID
- FMASU Ms 778/2022
- Conditions
- Methohexitone Pulmonary Adverse Reaction
- Keywords
- Methotrexate Therapy,, CT Chest, Spirometry Test, Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Age more than 18 yr rheumatoid arthritis more than one year, all patients were under RA Treatment for more than one year
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heba M Shalaby, MD principal investigator
Ain Shams University, Faculty of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Methohexitone Pulmonary Adverse Reaction, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HRCT Chest and spirometry test findings in RA Egyptian patients, and their relationship to Methotrexate therapy, disease duration, and activity. (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.