Rheumatoid ArthritisNCT04937140
Assessment of 14-3-3 η (Eta) Protein Antibodies in the Serum of Rheumatoid Arthritis Patients and Its Relation to Atherosclerosis.
An observational study of Rheumatoid Arthritis, run by Sohag University.
Trial summary
The aims of this study are: • To assess 14-3-3 η (eta) protein antibodies in the serum of rheumatoid arthritis patients and its relation to disease activity and severity. • To investigate the role of 14-3-3 η (eta) protein in the diagnosis or assessment of subclinical carotid artery atherosclerosis. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- 14-3-3 η (eta) protein antibodies in the serum of rheumatoid arthritis patients
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- Sep 2021to Sep 2022
- How long will I take part?
- 1 Year
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: This study will include 90 RA patients diagnosed according to the American college of rheumatology (ACR) -EULAR RA classification criteria 2010 in addition to 50 age and sex matched healthy controls. All the patients will be recruited from Rheumatology and Rehabilitation outpatient clinic in Sohag University Hospitals, Faculty of Medicine . Patients
Who may be able to join
- Patients with RA classified according to the revised American College of Rheumatology (ACR)/EULAR RA classification criteria 2010 for RA.
- Age ≥ 18 years.
- Patients who are able and willing to give written informed consent.
- Disease duration more than one year
Who cannot join
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- Any other autoimmune disease rather than RA.
- Patients with any disease affecting the cardiovascular system other than RA.
- Patients with known risk factors for atherosclerosis as diabetes, hypertension, hyperlipidemia and obesity.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 14-3-3 η (Eta) Protein as a Marker of Disease Activity, Severity and Subclinical Atherosclerosis in Patients With Rheumatoid Arthritis.
The aims of this study are: • To assess 14-3-3 η (eta) protein antibodies in the serum of rheumatoid arthritis patients and its relation to disease activity and severity. • To investigate the role of 14-3-3 η (eta) protein in the diagnosis or assessment of subclinical carotid artery atherosclerosis.
Read the detailed description
All the patients will be interviewed for demographic and clinical data (age, sex, occupation, age at onset of the disease, joints affected, extra-articular features, disease duration, family history and treatment regimen). • Assessment of medical and rheumatologic history.
- Careful general and musculoskeletal examination.
- Assessment of disease activity will be performed using the Disease Activity Score (DAS28) including 28 tender and swollen joint count, ESR and visual analogue scale.
- X-ray both hands and feet
- Larsen Score
- Assessment of Body Mass Index (BMI)
- Laboratory investigations:
- Complete blood count (CBC) • Rheumatoid factor (RF) by latex method • Anti citrullinated protein antibodies ACPA by enzyme-linked immunosorbent assay (ELISA) • 14-3-3 η (eta) protein by (ELISA) • Erythrocytic sedimentation rate (ESR) • Quantitative C-reactive protein (CRP) • fasting blood glucose • lipid profile • Carotid Doppler ultrasound (for measurement of carotid intima media thickness and detection of plaques) • ECG
- Conditions
- Rheumatoid Arthritis
- Being tested
- 14-3-3 η (eta) protein antibodies in the serum of rheumatoid arthritis patients
- Keywords
- RA
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
14-3-3 η (eta) protein antibodies in the serum of rheumatoid arthritis patientsDiagnostic test
Also called Carotid Doppler ultrasound (for measurement of carotid intima media thickness and detection of plaques)
assessment of 14-3-3 η (eta) protein antibodies in the serum of rheumatoid arthritis patients and Carotid Doppler ultrasound (for measurement of carotid intima media thickness and detection of plaques)
| Study group | Role | What they receive |
|---|---|---|
| rheumatoid arthritis patients | 90 RA patients diagnosed according to the American college of rheumatology (ACR) -EULAR RA classification criteria 2010 Receives: Diagnostic Test: 14-3-3 η (eta) protein antibodies in the serum of rheumatoid arthritis patients | |
| control group | 50 age and sex matched healthy controls. All Receives: Diagnostic Test: 14-3-3 η (eta) protein antibodies in the serum of rheumatoid arthritis patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
14-3-3 eta protein as measured by enzyme-linked immunosorbent assay (ELISA) in the serum of the participants and carotid intima media thickness as determined by carotid doppler ultrasound
relation between presence of 14-3-3 η (eta)by enzyme-linked immunosorbent assay (ELISA) in the serum of the participants and carotid intima media thickness and detection of plaques
Measured: through study completion, an average of 1 year"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study startSep 2021 (estimated)
- Primary completionAug 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Adel Ibrahim, Sohag University
- Investigators
- doaa adel, specialist, Principal investigator, In the Medical Administration Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04937140
- Sponsor's protocol ID
- Soh-Med-21-06-11
- Status last verified
- Jun 2021
- First submitted
- 14 Jun 2021
- Last updated
- 23 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 14-3-3 η (Eta) Protein as a Marker of Disease Activity, Severity and Subclinical Atherosclerosis in Patients With Rheumatoid Arthritis.
- ClinicalTrials.gov ID
- NCT04937140
- Acronym / sponsor ID
- Soh-Med-21-06-11
- Conditions
- Rheumatoid Arthritis
- Keywords
- RA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Sep 2021 (estimated)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 23 Jun 2021 (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.
The aims of this study are: • To assess 14-3-3 η (eta) protein antibodies in the serum of rheumatoid arthritis patients and its relation to disease activity and severity. • To investigate the role of 14-3-3 η (eta) protein in the diagnosis or assessment of subclinical carotid artery atherosclerosis.
Detailed description
All the patients will be interviewed for demographic and clinical data (age, sex, occupation, age at onset of the disease, joints affected, extra-articular features, disease duration, family history and treatment regimen). • Assessment of medical and rheumatologic history.
- Careful general and musculoskeletal examination.
- Assessment of disease activity will be performed using the Disease Activity Score (DAS28) including 28 tender and swollen joint count, ESR and visual analogue scale.
- X-ray both hands and feet
- Larsen Score
- Assessment of Body Mass Index (BMI)
- Laboratory investigations:
- Complete blood count (CBC) • Rheumatoid factor (RF) by latex method • Anti citrullinated protein antibodies ACPA by enzyme-linked immunosorbent assay (ELISA) • 14-3-3 η (eta) protein by (ELISA) • Erythrocytic sedimentation rate (ESR) • Quantitative C-reactive protein (CRP) • fasting blood glucose • lipid profile • Carotid Doppler ultrasound (for measurement of carotid intima media thickness and detection of plaques) • ECG
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rheumatoid arthritis patients | – | Diagnostic Test: 14-3-3 η (eta) protein antibodies in the serum of rheumatoid arthritis patients90 RA patients diagnosed according to the American college of rheumatology (ACR) -EULAR RA classification criteria 2010 |
| control group | – | Diagnostic Test: 14-3-3 η (eta) protein antibodies in the serum of rheumatoid arthritis patients50 age and sex matched healthy controls. All |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This study will include 90 RA patients diagnosed according to the American college of rheumatology (ACR) -EULAR RA classification criteria 2010 in addition to 50 age and sex matched healthy controls. All the patients will be recruited from Rheumatology and Rehabilitation outpatient clinic in Sohag University Hospitals, Faculty of Medicine . Patients
Key inclusion criteria (4 listed)
Key exclusion criteria (4 listed)
- <!-- -->
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 14-3-3 η (eta) protein antibodies in the serum of rheumatoid arthritis patientsAlso: Carotid Doppler ultrasound (for measurement of carotid intima media thickness and detection of plaques)assessment of 14-3-3 η (eta) protein antibodies in the serum of rheumatoid arthritis patients and Carotid Doppler ultrasound (for measurement of carotid intima media thickness and detection of plaques) | Diagnostic test | control group, rheumatoid arthritis patients |
Primary outcome
14-3-3 eta protein as measured by enzyme-linked immunosorbent assay (ELISA) in the serum of the participants and carotid intima media thickness as determined by carotid doppler ultrasound
Time frame: through study completion, an average of 1 year"
relation between presence of 14-3-3 η (eta)by enzyme-linked immunosorbent assay (ELISA) in the serum of the participants and carotid intima media thickness and detection of plaques
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2021.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
doaa adel, specialist principal investigator
In the Medical Administration Sohag University
Questions about this trial
What is this clinical trial studying?
An observational study of 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 23 Jun 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact doaa adel, specialist (01201786669, doaa_adel_post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
14-3-3 eta protein as measured by enzyme-linked immunosorbent assay (ELISA) in the serum of the participants and carotid intima media thickness as determined by carotid doppler ultrasound (time frame: through study completion, an average of 1 year"). 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 23 Jun 2021.