Sonographic Signs of Gouty Arthritis in Diagnosed and Suspected PatientsNCT04734093
Sonographic Signs of Gouty Arthritis in a Cohort of Egyptian Patients: a Cross Sectional Multicenter Study
An observational study of Sonographic Signs of Gouty Arthritis in Diagnosed and Suspected Patients, run by Sohag University at 1 site in Egypt.
Trial summary
The study is a cross sectional observational multicenter study. It is established in collaboration with the Egyptian college of rheumatology study group (ECRsg). It is conditioned that all the study participants had either mono- or oligo-arthritis with effusion of the knee or the first metatarsophalangeal (MTP) joint… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Sonographic Signs of Gouty Arthritis in Diagnosed and Suspected Patients
- What is being tested?
- Evaluation of sonographic signs of gouty arthritis
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Nov 2020to 16 Apr 2021
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will be collected from several university clinics all over Egypt. All are aged 40 or more with a history of definite gouty arthritis or at high risk and they have active arthritis of at least one joint.
Who may be able to join
- mono- or oligo-arthritis with effusion of the knee or the first metatarsophalangeal
- patients with a known history of gout or at high risk
Who cannot join
- Patients with any known chronic arthritis, comprising rheumatoid arthritis, Sjoegren's syndrome, systemic lupus erythematosus, scleroderma, neuropathic arthritis, seronegative spondyloarthropathy
- History of intra-articular injection in the last 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
The study is a cross sectional observational multicenter study. It is established in collaboration with the Egyptian college of rheumatology study group (ECRsg). It is conditioned that all the study participants had either mono- or oligo-arthritis with effusion of the knee or the first metatarsophalangeal (MTP) joint in patients with a known history of gout or at high risk. Patients with any known chronic arthritis, comprising rheumatoid arthritis, Sjogren's syndrome, systemic lupus erythematosus, scleroderma, neuropathic arthritis, seronegative spondyloarthropathy, will be excluded from the study. None of the participants had a history of intra-articular injection or aspiration in the scanned joints for 3 months prior to the inclusion in the study. The sonographers will be blinded for clinical data and the EULAR scanning protocol for the knee and 1st MTP will be considered [2]. Further, scanning of the double contour sign over the femur condyles anteriorly and posteriorly in sagittal planes will be assessed. All the sonographers in the study had an experience between 5 and 10 years in the field of musculoskeletal ultrasound.
- Being tested
- Evaluation of sonographic signs of gouty arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of sonographic signs of gouty arthritisDiagnostic test
the EULAR scanning protocol for the knee and 1st MTP will be considered [2]. Further, scanning of the double contour sign over the femur condyles anteriorly and posteriorly in sagittal planes will be assessed. Examination of erosions, tophus, double contour, effusion, and echogenic foci will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Sohag university recruited patients | Not described Receives: Diagnostic Test: Evaluation of sonographic signs of gouty arthritis | |
| Minia university recruited patients | Not described Receives: Diagnostic Test: Evaluation of sonographic signs of gouty arthritis | |
| Assuit university recruited patients | Not described Receives: Diagnostic Test: Evaluation of sonographic signs of gouty arthritis | |
| Kasr Elini recruited patients | Not described Receives: Diagnostic Test: Evaluation of sonographic signs of gouty arthritis | |
| Tanta university recruited patients | Not described Receives: Diagnostic Test: Evaluation of sonographic signs of gouty arthritis | |
| Monofia university recruited patients | Not described Receives: Diagnostic Test: Evaluation of sonographic signs of gouty arthritis | |
| Aswan university recruited patients | Not described Receives: Diagnostic Test: Evaluation of sonographic signs of gouty arthritis | |
| Ain shams university recruited patients | Not described Receives: Diagnostic Test: Evaluation of sonographic signs of gouty arthritis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sonographic signs of gouty arthritis in the knee or 1st MTP joint
Erosions, effusion, echogenic foci, and tophus using OMERACT definitions of sonographic signs of gouty arthritis
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start15 Nov 2020
- Primary completion16 Apr 2021
- Study completion16 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sonographic Signs of Gouty Arthritis in Diagnosed and Suspected PatientsStudies 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
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mahrous, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04734093
- Sponsor's protocol ID
- 21130
- Status last verified
- May 2021
- First submitted
- 28 Jan 2021
- Last updated
- 4 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sonographic Signs of Gouty Arthritis in a Cohort of Egyptian Patients: a Cross Sectional Multicenter Study
- ClinicalTrials.gov ID
- NCT04734093
- Acronym / sponsor ID
- 21130
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 Nov 2020 (actual)
- Primary completion
- 16 Apr 2021 (actual)
- Study completion
- 16 Apr 2021 (actual)
- First posted
- 2 Feb 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 study is a cross sectional observational multicenter study. It is established in collaboration with the Egyptian college of rheumatology study group (ECRsg). It is conditioned that all the study participants had either mono- or oligo-arthritis with effusion of the knee or the first metatarsophalangeal (MTP) joint in patients with a known history of gout or at high risk. Patients with any known chronic arthritis, comprising rheumatoid arthritis, Sjogren's syndrome, systemic lupus erythematosus, scleroderma, neuropathic arthritis, seronegative spondyloarthropathy, will be excluded from the study. None of the participants had a history of intra-articular injection or aspiration in the scanned joints for 3 months prior to the inclusion in the study. The sonographers will be blinded for clinical data and the EULAR scanning protocol for the knee and 1st MTP will be considered [2]. Further, scanning of the double contour sign over the femur condyles anteriorly and posteriorly in sagittal planes will be assessed. All the sonographers in the study had an experience between 5 and 10 years in the field of musculoskeletal ultrasound.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Sohag university recruited patients | – | Diagnostic Test: Evaluation of sonographic signs of gouty arthritis |
| Minia university recruited patients | – | Diagnostic Test: Evaluation of sonographic signs of gouty arthritis |
| Assuit university recruited patients | – | Diagnostic Test: Evaluation of sonographic signs of gouty arthritis |
| Kasr Elini recruited patients | – | Diagnostic Test: Evaluation of sonographic signs of gouty arthritis |
| Tanta university recruited patients | – | Diagnostic Test: Evaluation of sonographic signs of gouty arthritis |
| Monofia university recruited patients | – | Diagnostic Test: Evaluation of sonographic signs of gouty arthritis |
| Aswan university recruited patients | – | Diagnostic Test: Evaluation of sonographic signs of gouty arthritis |
| Ain shams university recruited patients | – | Diagnostic Test: Evaluation of sonographic signs of gouty arthritis |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be collected from several university clinics all over Egypt. All are aged 40 or more with a history of definite gouty arthritis or at high risk and they have active arthritis of at least one joint.
Key inclusion criteria (2 listed)
- mono- or oligo-arthritis with effusion of the knee or the first metatarsophalangeal
- patients with a known history of gout or at high risk
Key exclusion criteria (2 listed)
- Patients with any known chronic arthritis, comprising rheumatoid arthritis, Sjoegren's syndrome, systemic lupus erythematosus, scleroderma, neuropathic arthritis, seronegative spondyloarthropathy
- History of intra-articular injection in the last 3 months.
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 |
|---|---|---|
| Evaluation of sonographic signs of gouty arthritisthe EULAR scanning protocol for the knee and 1st MTP will be considered [2]. Further, scanning of the double contour sign over the femur condyles anteriorly and posteriorly in sagittal planes will be assessed. Examination of erosions, tophus, double contour, effusion, and echogenic foci will be recorded. | Diagnostic test | Ain shams university recruited patients, Assuit university recruited patients, Aswan university recruited patients, Kasr Elini recruited patients, Minia university recruited patients, Monofia university recruited patients, Sohag university recruited patients, Tanta university recruited patients |
Primary outcome
Sonographic signs of gouty arthritis in the knee or 1st MTP joint
Time frame: at baseline
Erosions, effusion, echogenic foci, and tophus using OMERACT definitions of sonographic signs of gouty arthritis
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 4 May 2021.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Sonographic Signs of Gouty Arthritis in Diagnosed and Suspected Patients, run by Sohag 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 2 inclusion and 2 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 4 May 2021. 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?
Sonographic signs of gouty arthritis in the knee or 1st MTP joint (time frame: at baseline). 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 4 May 2021.