RA - Rheumatoid ArthritisNCT07796841
GAS5 Gene Expression and IL-6 in Rheumatoid Arthritis
An observational study of RA - Rheumatoid Arthritis, run by Sohag University.
Trial summary
This study aims to investigate the expression of Growth Arrest-Specific 5 (GAS5) , a long non-coding RNA , in patients with Rheumatoid Arthritis compared with healthy individuals. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- RA - Rheumatoid Arthritis
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients diagnosed with Rheumatoid Arthritis according to 2010 ACR/EULAR classification criteria and healthy controls participants who meet the predefined eligibility criteria
Who may be able to join
- Adult patients older than 18 years patients diagnosed with Rheumatoid Arthritis according to the 2010 American collage Rheumatology / European League against Rheumatism (ACR/EULAR) classification criteria
Who cannot join
- Patients who did not meet the previous inclusion criteria
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Expression of Growth Arrest-Specific 5 (GAS5) Long Non-Coding RNA and Serum Interlukin-6 Levels in Patients With Rheumatoid Arthritis
This study aims to investigate the expression of Growth Arrest-Specific 5 (GAS5) , a long non-coding RNA , in patients with Rheumatoid Arthritis compared with healthy individuals. The study will also assess the level of Interlukin-6 (IL-6) in the blood and explore the relationship between GAS5 expression and IL-6 levels in Rheumatoid Arthritis
Read the detailed description
Rheumatoid arthritis (RA) is a chronic systemic autoimmune disease characterized by persistent inflammation of the joints and may result in progressive joint damage and functional impairment. The mechanisms underlying the development and progression of RA involve complex interactions between immune, inflammatory, and molecular pathways.
Long non-coding RNAs (lncRNAs) are regulatory RNA molecules that can influence gene expression and participate in various biological processes, including immune regulation and inflammation. Growth Arrest-Specific 5 (GAS5) is a long non-coding RNA that has been implicated in the regulation of inflammatory and immune-related processes and may have a role in autoimmune diseases.
Interleukin-6 (IL-6) is an important pro-inflammatory cytokine involved in the inflammatory response and pathogenesis of rheumatoid arthritis. Assessment of IL-6 levels may provide information regarding the inflammatory status of patients with RA.
This observational study will compare GAS5 expression and blood IL-6 levels between patients with rheumatoid arthritis and healthy controls. Blood samples will be collected from eligible participants. GAS5 expression will be assessed using quantitative real-time polymerase chain reaction (qRT-PCR), while IL-6 levels will be measured using an enzyme-linked immunosorbent assay (ELISA).
The study will also examine the relationship between these molecular and inflammatory markers and selected clinical and laboratory characteristics of rheumatoid arthritis. The findings may contribute to a better understanding of the molecular mechanisms involved in RA and the potential role of GAS5 and IL-6 in the disease.
- Conditions
- RA - 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 |
|---|---|---|
| Rheumatoid Arthritis | Participants diagnosed with Rhemutoid Arthritis who meet the predefined eligibility criteria and will undergo assessment of GAS5 gene expression and serum interlukin-6 (IL-6) levels | |
| Healthy Controls | Healthy participants without Rheumatoid Arthritis who meet the predefined eligibilty criteria and will undergo assessment of GAS5 gene expression and serum interlukin-6 (IL-6) |
What is being measured
The primary outcome is the main question the study is designed to answer.
GAS5 gene expression level
GAS5 long non-coding RNA expression level in preipheral blood samples , assessed by quantitative real-time polymerase chain reaction (qRT-PCR) and compared between patients with rheumatoid arthritis and healthy controls
Measured: at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RA - Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samar Mohamed Abozaid, Sohag University
- Investigators
- Samar Mohamed Abozaid, Biochemistry demonstrator, Principal investigator, Faculty of Medicine , Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07796841
- Sponsor's protocol ID
- Soh-Med-26-8-16MS
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hegazy GA-F, Shaker O, Aly O, Zaki HH, Herzalla MR, Gomaa AF, Sayed S, Haroon MM. Expression of Two Long Noncoding Ribonucleic Acids (Growth Arrest-Specific 5 and H19) in Rheumatoid Arthritis Patients: Relation to Clinical Characteristics and Disease Activity. Indian Journal of Rheumatology. 2021;16(2):152-158.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression of Growth Arrest-Specific 5 (GAS5) Long Non-Coding RNA and Serum Interlukin-6 Levels in Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT07796841
- Acronym / sponsor ID
- Soh-Med-26-8-16MS
- Conditions
- RA - Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 1 Sep 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.
This study aims to investigate the expression of Growth Arrest-Specific 5 (GAS5) , a long non-coding RNA , in patients with Rheumatoid Arthritis compared with healthy individuals. The study will also assess the level of Interlukin-6 (IL-6) in the blood and explore the relationship between GAS5 expression and IL-6 levels in Rheumatoid Arthritis
Detailed description
Rheumatoid arthritis (RA) is a chronic systemic autoimmune disease characterized by persistent inflammation of the joints and may result in progressive joint damage and functional impairment. The mechanisms underlying the development and progression of RA involve complex interactions between immune, inflammatory, and molecular pathways.
Long non-coding RNAs (lncRNAs) are regulatory RNA molecules that can influence gene expression and participate in various biological processes, including immune regulation and inflammation. Growth Arrest-Specific 5 (GAS5) is a long non-coding RNA that has been implicated in the regulation of inflammatory and immune-related processes and may have a role in autoimmune diseases.
Interleukin-6 (IL-6) is an important pro-inflammatory cytokine involved in the inflammatory response and pathogenesis of rheumatoid arthritis. Assessment of IL-6 levels may provide information regarding the inflammatory status of patients with RA.
This observational study will compare GAS5 expression and blood IL-6 levels between patients with rheumatoid arthritis and healthy controls. Blood samples will be collected from eligible participants. GAS5 expression will be assessed using quantitative real-time polymerase chain reaction (qRT-PCR), while IL-6 levels will be measured using an enzyme-linked immunosorbent assay (ELISA).
The study will also examine the relationship between these molecular and inflammatory markers and selected clinical and laboratory characteristics of rheumatoid arthritis. The findings may contribute to a better understanding of the molecular mechanisms involved in RA and the potential role of GAS5 and IL-6 in the disease.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rheumatoid Arthritis | – | –Participants diagnosed with Rhemutoid Arthritis who meet the predefined eligibility criteria and will undergo assessment of GAS5 gene expression and serum interlukin-6 (IL-6) levels |
| Healthy Controls | – | –Healthy participants without Rheumatoid Arthritis who meet the predefined eligibilty criteria and will undergo assessment of GAS5 gene expression and serum interlukin-6 (IL-6) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients diagnosed with Rheumatoid Arthritis according to 2010 ACR/EULAR classification criteria and healthy controls participants who meet the predefined eligibility criteria
Key inclusion criteria (1 listed)
- Adult patients older than 18 years patients diagnosed with Rheumatoid Arthritis according to the 2010 American collage Rheumatology / European League against Rheumatism (ACR/EULAR) classification criteria
Key exclusion criteria (1 listed)
- Patients who did not meet the previous inclusion criteria
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
GAS5 gene expression level
Time frame: at enrollment
GAS5 long non-coding RNA expression level in preipheral blood samples , assessed by quantitative real-time polymerase chain reaction (qRT-PCR) and compared between patients with rheumatoid arthritis and healthy controls
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Results publicationHegazy GA-F, Shaker O, Aly O, Zaki HH, Herzalla MR, Gomaa AF, Sayed S, Haroon MM. Expression of Two Long Noncoding Ribonucleic Acids (Growth Arrest-Specific 5 and H19) in Rheumatoid Arthritis Patients: Relation to Clinical Characteristics and Disease Activity. Indian Journal of Rheumatology. 2021;16(2):152-158.
- Individual participant dataSharing planned: Undecided
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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.
Samar Mohamed Abozaid, Biochemistry demonstrator principal investigator
Faculty of Medicine , Sohag University
Questions about this trial
What is this clinical trial studying?
An observational study of RA - Rheumatoid Arthritis, run by Sohag University.
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: opening soon, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samar Mohamed Abozaid, Biochemistry demonstrator (+20 1026386368, sm3962539@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GAS5 gene expression level (time frame: at enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07796841, which also lists 1 linked publication.
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 1 Sep 2026.