Musckloskeletal USNCT07067606
Role of Musculoskeletal Ultrasound for Early Detection of Synovitis in SLE Patient and Its Correlation With Disease Activity and Neutrophil-to-C3 Ratio.
An observational study of Musckloskeletal US, run by Mervat Sayed Kamal Sayed.
Trial summary
Systemic lupus erythematosus (SLE) is a clinically common autoimmune disease characterized by abnormal immune response to autologous tissue, eventually resulting in systemic disorders and diverse clinical manifestations. The prevalence of women is significantly higher than that of men. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Musckloskeletal US
- What is being tested?
- ultrasound contrast
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2025to 30 Dec 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: non probability
Who may be able to join
- SLE patients without musculoskeletal manifestations diagnosed according to European League against Rheumatism (EULAR) and the American college of Rheumatology (ACR)criteria for classification of SLE.
Who cannot join
- • Overlap syndrome as rhupus patients, those with trauma, osteoarthritis, surgery of hand and wrist
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
Systemic lupus erythematosus (SLE) is a clinically common autoimmune disease characterized by abnormal immune response to autologous tissue, eventually resulting in systemic disorders and diverse clinical manifestations. The prevalence of women is significantly higher than that of men.
Musculoskeletal and joint affection represents one of the most common manifestations of systemic lupus erythematosus (SLE), and 95% of them have either arthralgia or arthritis during their disease course.
Read more
SLE arthropathy has main three different clinical types: nondeforming nonerosive arthritis; the most common type, deforming nonerosive arthropathy (Jaccoud's arthropathy) which has no bone erosions on conventional radiography and exists in up to 15% of the patients and erosive arthropathy (rhupus syndrome) which is overlap syndrome between rheumatoid arthritis (RA) and SLE and exist in <5% of lupus patients.
In clinical practice, most lupus patients who have joint and tendon pains often have no apparent inflammation during physical examination. Joint and tendon inflammation has been documented in musculoskeletal ultrasound in patients without any signs of arthritis, thus suggesting the role of ultrasound in the evaluation of patients with nonspecific musculoskeletal manifestations such as arthralgia. And detection of the presence of underlying subclinical inflammatory changes.
Components of lymphocytes, antibodies, inflammatory cytokines, and complements in peripheral circulation vary among different active stages of SLE. Patients with higher disease activity often damage tissues and organs, many of which even threaten life. It is of great significance in SLE management to early and accurately determine the disease activity of patients.
We will investigate the role of musculoskeletal ultrasound for early detection of synovitis in SLE patients and its correlation with disease activity and neutrophil-to-C3 ratio (NC3R).
Read the detailed description
All participants will be subjected to full history taking, full clinical examination, laboratory investigations (complete blood count, erythrocyte sedimentation rate [ESR], C-reactive protein [CRP], blood urea, serum creatinine, serum glutamic-oxaloacetic transaminase [SGOT], serum glutamate-pyruvate transaminase [SGPT], immunological tests (antinuclear and anti-DNA antibodies and C3 and C4 levels), urine analysis, and 24-h urinary protein). SLE disease activity index (SELDAI) will be calculated for every patient.
Musculoskeletal examination with power Doppler, the ultrasound examination will be performed at the musculoskeletal ultrasonography unit at the rheumatology division of the internal medicine department. Bilateral musculoskeletal US examinations of hands and wrists with power Doppler (PD) evaluation will be done for all patients. US examinations were performed using the standardized scanning technique according to EULAR guidelines for musculoskeletal US in rheumatology.
- Conditions
- Musckloskeletal US
- Being tested
- ultrasound contrast
- Keywords
- muskluskeletal US - SLE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound contrastDevice
All participants will be subjected to full history taking, full clinical examination, laboratory investigations (complete blood count, erythrocyte sedimentation rate [ESR], C-reactive protein [CRP], blood urea, serum creatinine, serum glutamic-oxaloacetic transaminase [SGOT], serum glutamate-pyruvate transaminase [SGPT], immunological tests (antinuclear and anti-DNA antibodies and C3 and C4 levels), urine analysis, and 24-h urinary protein). SLE disease activity index (SELDAI) will be also calculated for every patient. (8) Musculoskeletal examination with power Doppler, the ultrasound examination will be performed at the musculoskeletal ultrasonography unit at the rheumatology division of the internal medicine department. Bilateral musculoskeletal US examinations of hands and wrists with power Doppler (PD) evaluation will be done for all patients. US examinations were performed using the standardized scanning technique according to EULAR guidelines for musculoskeletal US in rheumatolog
What is being measured
The primary outcome is the main question the study is designed to answer.
Role of musculoskeletal ultrasound for early detection of synovitis in SLE patient and its correlation with disease activity and neutrophil-to-C3 ratio.
early detection of synovitis in SLE patient
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start30 Oct 2025 (estimated)
- Primary completion25 Oct 2027 (estimated)
- Study completion30 Dec 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 Musckloskeletal USStudies 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
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mervat Sayed Kamal Sayed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mervat Sayed Kamal Sayed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07067606
- Sponsor's protocol ID
- musculoskeletal US SLE
- Status last verified
- Jun 2025
- First submitted
- 6 Jul 2025
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Aringer M, Costenbader K, Daikh D, Brinks R, Mosca M, Ramsey-Goldman R, Smolen JS, Wofsy D, Boumpas DT, Kamen DL, Jayne D, Cervera R, Costedoat-Chalumeau N, Diamond B, Gladman DD, Hahn B, Hiepe F, Jacobsen S, Khanna D, Lerstrom K, Massarotti E, McCune J, Ruiz-Irastorza G, Sanchez-Guerrero J, Schneider M, Urowitz M, Bertsias G, Hoyer BF, Leuchten N, Tani C, Tedeschi SK, Touma Z, Schmajuk G, Anic B, Assan F, Chan TM, Clarke AE, Crow MK, Czirjak L, Doria A, Graninger W, Halda-Kiss B, Hasni S, Izmirly PM, Jung M, Kumanovics G, Mariette X, Padjen I, Pego-Reigosa JM, Romero-Diaz J, Rua-Figueroa Fernandez I, Seror R, Stummvoll GH, Tanaka Y, Tektonidou MG, Vasconcelos C, Vital EM, Wallace DJ, Yavuz S, Meroni PL, Fritzler MJ, Naden R, Dorner T, Johnson SR. 2019 European League Against Rheumatism/American College of Rheumatology Classification Criteria for Systemic Lupus Erythematosus. Arthritis Rheumatol. 2019 Sep;71(9):1400-1412. doi: 10.1002/art.40930. Epub 2019 Aug 6.
PubMed 31385462
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Musculoskeletal Ultrasound for Early Detection of Synovitis in SLE Patient and Its Correlation With Disease Activity and Neutrophil-to-C3 Ratio.
- ClinicalTrials.gov ID
- NCT07067606
- Acronym / sponsor ID
- musculoskeletal US SLE
- Conditions
- Musckloskeletal US
- Keywords
- muskluskeletal US - SLE
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Mervat Sayed Kamal SayedUniversity, hospital or other
- Study start
- 30 Oct 2025 (estimated)
- Primary completion
- 25 Oct 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 16 Jul 2025 (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.
Systemic lupus erythematosus (SLE) is a clinically common autoimmune disease characterized by abnormal immune response to autologous tissue, eventually resulting in systemic disorders and diverse clinical manifestations. The prevalence of women is significantly higher than that of men.
Musculoskeletal and joint affection represents one of the most common manifestations of systemic lupus erythematosus (SLE), and 95% of them have either arthralgia or arthritis during their disease course.
SLE arthropathy has main three different clinical types: nondeforming nonerosive arthritis; the most common type, deforming nonerosive arthropathy (Jaccoud's arthropathy) which has no bone erosions on conventional radiography and exists in up to 15% of the patients and erosive arthropathy (rhupus syndrome) which is overlap syndrome between rheumatoid arthritis (RA) and SLE and exist in <5% of lupus patients.
In clinical practice, most lupus patients who have joint and tendon pains often have no apparent inflammation during physical examination. Joint and tendon inflammation has been documented in musculoskeletal ultrasound in patients without any signs of arthritis, thus suggesting the role of ultrasound in the evaluation of patients with nonspecific musculoskeletal manifestations such as arthralgia. And detection of the presence of underlying subclinical inflammatory changes.
Components of lymphocytes, antibodies, inflammatory cytokines, and complements in peripheral circulation vary among different active stages of SLE. Patients with higher disease activity often damage tissues and organs, many of which even threaten life. It is of great significance in SLE management to early and accurately determine the disease activity of patients.
We will investigate the role of musculoskeletal ultrasound for early detection of synovitis in SLE patients and its correlation with disease activity and neutrophil-to-C3 ratio (NC3R).
Detailed description
All participants will be subjected to full history taking, full clinical examination, laboratory investigations (complete blood count, erythrocyte sedimentation rate [ESR], C-reactive protein [CRP], blood urea, serum creatinine, serum glutamic-oxaloacetic transaminase [SGOT], serum glutamate-pyruvate transaminase [SGPT], immunological tests (antinuclear and anti-DNA antibodies and C3 and C4 levels), urine analysis, and 24-h urinary protein). SLE disease activity index (SELDAI) will be calculated for every patient.
Musculoskeletal examination with power Doppler, the ultrasound examination will be performed at the musculoskeletal ultrasonography unit at the rheumatology division of the internal medicine department. Bilateral musculoskeletal US examinations of hands and wrists with power Doppler (PD) evaluation will be done for all patients. US examinations were performed using the standardized scanning technique according to EULAR guidelines for musculoskeletal US in rheumatology.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- non probability
Key inclusion criteria (1 listed)
- SLE patients without musculoskeletal manifestations diagnosed according to European League against Rheumatism (EULAR) and the American college of Rheumatology (ACR)criteria for classification of SLE.
Key exclusion criteria (1 listed)
- • Overlap syndrome as rhupus patients, those with trauma, osteoarthritis, surgery of hand and wrist
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 |
|---|---|---|
| ultrasound contrastAll participants will be subjected to full history taking, full clinical examination, laboratory investigations (complete blood count, erythrocyte sedimentation rate [ESR], C-reactive protein [CRP], blood urea, serum creatinine, serum glutamic-oxaloacetic transaminase [SGOT], serum glutamate-pyruvate transaminase [SGPT], immunological tests (antinuclear and anti-DNA antibodies and C3 and C4 levels), urine analysis, and 24-h urinary protein). SLE disease activity index (SELDAI) will be also calculated for every patient. (8) Musculoskeletal examination with power Doppler, the ultrasound examination will be performed at the musculoskeletal ultrasonography unit at the rheumatology division of the internal medicine department. Bilateral musculoskeletal US examinations of hands and wrists with power Doppler (PD) evaluation will be done for all patients. US examinations were performed using the standardized scanning technique according to EULAR guidelines for musculoskeletal US in rheumatolog | Device | – |
Primary outcome
Role of musculoskeletal ultrasound for early detection of synovitis in SLE patient and its correlation with disease activity and neutrophil-to-C3 ratio.
Time frame: baseline
early detection of synovitis in SLE patient
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 16 Jul 2025.
- Results publication: PubMed 31385462Aringer M, Costenbader K, Daikh D, Brinks R, Mosca M, Ramsey-Goldman R, Smolen JS, Wofsy D, Boumpas DT, Kamen DL, Jayne D, Cervera R, Costedoat-Chalumeau N, Diamond B, Gladman DD, Hahn B, Hiepe F, Jacobsen S, Khanna D, Lerstrom K, Massarotti E, McCune J, Ruiz-Irastorza G, Sanchez-Guerrero J, Schneider M, Urowitz M, Bertsias G, Hoyer BF, Leuchten N, Tani C, Tedeschi SK, Touma Z, Schmajuk G, Anic B, Assan F, Chan TM, Clarke AE, Crow MK, Czirjak L, Doria A, Graninger W, Halda-Kiss B, Hasni S, Izmirly PM, Jung M, Kumanovics G, Mariette X, Padjen I, Pego-Reigosa JM, Romero-Diaz J, Rua-Figueroa Fernandez I, Seror R, Stummvoll GH, Tanaka Y, Tektonidou MG, Vasconcelos C, Vital EM, Wallace DJ, Yavuz S, Meroni PL, Fritzler MJ, Naden R, Dorner T, Johnson SR. 2019 European League Against Rheumatism/American College of Rheumatology Classification Criteria for Systemic Lupus Erythematosus. Arthritis Rheumatol. 2019 Sep;71(9):1400-1412. doi: 10.1002/art.40930. Epub 2019 Aug 6.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Musckloskeletal US, run by Mervat Sayed Kamal Sayed.
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 16 Jul 2025. 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 Mervat Sayed Kamal, assistant lecturer (01018602654, Mervetkamal@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Role of musculoskeletal ultrasound for early detection of synovitis in SLE patient and its correlation with disease activity and neutrophil-to-C3 ratio. (time frame: baseline). 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 NCT07067606, 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 16 Jul 2025.