System Lupus ErythematosusNCT05106998
NFC Changes in SLE Patients and Its Correlation With Anti-U1RNPAntibodies and Disease Activity
An observational study of System Lupus Erythematosus, run by Assiut University.
Trial summary
1. Detection of different pattern of nail fold capillary changes in SLE patient. 2. Correlation of nail fold capillary changes in SLE patients and Anti-U1RNP antibodies. 3. Correlation of nail fold capillary changes with SLE disease activity. 4. Frequency of nail fold capillary changes in SLE patients Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- System Lupus Erythematosus
- What is being tested?
- nailfold capillaroscopy
- Type of treatment
- Medical device
- How many people
- 85 participants
- Where
- No sites listed yet
- Study dates
- Mar 2022to Jun 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: : Collected from Rheumatology, Rehabilitation and Physical Medicine Department, inpatient and outpatient clinics , Assiut University Hospital
Who may be able to join
- Adult SLE Patients who fulfilled the 2012 systemic lupus international collaborating clinics (SLICC) criteria
Who cannot join
- SLE patient aged less than 18 yeares old.
- Individuals with other autoimmune diseases (rheumatoid arthritis dermatomyositis, scleroderma, mixed connective tissue disease).
- Congestive cardic failure and presence of clupping.
- Coexisting diabetes mellitus.
- history of smoking.
- Patients unable to co-operate for nailfold capillaroscopic examination
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Pattern of Nailfold Capillaroscopy Changes in Systemic Lupus Erythematosus Patients and Its Correlation With Anti-Uridin1-ribonucleoprotein Antibodies and Disease Activity
- Detection of different pattern of nail fold capillary changes in SLE patient.
- Correlation of nail fold capillary changes in SLE patients and Anti-U1RNP antibodies.
- Correlation of nail fold capillary changes with SLE disease activity.
- Frequency of nail fold capillary changes in SLE patients
Read the detailed description
Systemic lupus erythematosus is a complex, multi-organ autoimmune disease . The presence of autoantibodies and circulating immune complexes can cause vasculitis and damage the endothelial cells, leading to multiple organ dysfunctions .The clinical manifestations of SLE include muco cutaneous, musculoskeletal system, cardiac, neurological, renal, hematologic, and vascular system involvement . Nail fold capillaroscopy (NFC) is a non-invasive easily repeatable technique and the best method for morphological analysis of nutritional capillaries in the nail fold area . Nail fold capillary changes are very common in patients with SLE. the major NFC pattern that has been reported in SLE patients was non-specific sub-types, followed by normal pattern and scleroderma pattern. In (SLE) patients are reported a large spectrum of antibodies, including the anti-ribonucleoproteins (RNP) antibodies These antibodies were linked to several clinical manifestations and prognostic in patients with SLE. Anti-U1-RNP antibodies are involved in both innate and adaptive immune responses during pathogenesis of connective tissue diseases 12. U1-RNP complex is an intra nuclear protein that converts pre-mRNA to mature RNA and constitutes three specific proteins A, C, and 70 kDa. High titer RNP antibodies are detected in MCTD patients and correlated with Clinical disease activity index and the frequent complication of pulmonary artery hypertension in those patients . It also has been found that NFC may detect subclinical microvascular changes in SLE in the presence of anti-U1-RNP antibodies and may facilitate early preventive therapy for major organ vasculopathy .
- Conditions
- System Lupus Erythematosus
- Being tested
- nailfold capillaroscopy
- Keywords
- nailfold capillaroscopy, anti-U1RNP antibodies, Disease activity
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nailfold capillaroscopyDevice
Nailfold capillaroscopy (NFC) is a non-invasive easily repeatable technique and the best method for morphological analysis of nutritional capillaries in the nailfold area
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of nail fold capillary changes in SLE patient.
capillary changes on nailfold capillaroscopy examination for SLE patients
Measured: baseline
Secondary outcomes (3)
1- Detection of patterns of nailfold capillary changes in SLE .
to detect different patterns by nailfold capillaroscopy
Measured: baseline
2-Correlation of nailfold capillary changes in SLE patient and Anti-U1RNP antibodies.
relation of Anti U1 RNP antibodies and microvasculature as detected by NFC examination
Measured: baseline
3-Correlation of nailfold capillary changes with SLE disease activity .
relation of SLE disease activity and microvasculature as detected in NFC examination
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study startMar 2022 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for System Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Retrospective
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amera Imam Abdel - Ghany Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05106998
- Sponsor's protocol ID
- NFC in SLE , Anti-U1RNP Ab
- Status last verified
- Dec 2021
- First submitted
- 25 Oct 2021
- Last updated
- 14 Dec 2021
- Results posted
- No
- FDA-regulated device
- Yes
Publications
Zhao T, Lin FA, Chen HP. Pattern of Nailfold Capillaroscopy in Patients With Systemic Lupus Erythematosus. Arch Rheumatol. 2020 Apr 20;35(4):568-574. doi: 10.46497/ArchRheumatol.2020.7763. eCollection 2020 Dec.
PubMed 33758813Chebbi PP, Goel R, Ramya J, Gowri M, Herrick A, Danda D. Nailfold capillaroscopy changes associated with anti-RNP antibodies in systemic lupus erythematosus. Rheumatol Int. 2022 Aug;42(8):1355-1361. doi: 10.1007/s00296-021-04894-4. Epub 2021 Jun 2.
PubMed 34076720
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pattern of Nailfold Capillaroscopy Changes in Systemic Lupus Erythematosus Patients and Its Correlation With Anti-Uridin1-ribonucleoprotein Antibodies and Disease Activity
- ClinicalTrials.gov ID
- NCT05106998
- Acronym / sponsor ID
- NFC in SLE , Anti-U1RNP Ab
- Conditions
- System Lupus Erythematosus
- Keywords
- nailfold capillaroscopy, anti-U1RNP antibodies, Disease activity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2022 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 4 Nov 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.
- Detection of different pattern of nail fold capillary changes in SLE patient.
- Correlation of nail fold capillary changes in SLE patients and Anti-U1RNP antibodies.
- Correlation of nail fold capillary changes with SLE disease activity.
- Frequency of nail fold capillary changes in SLE patients
Detailed description
Systemic lupus erythematosus is a complex, multi-organ autoimmune disease . The presence of autoantibodies and circulating immune complexes can cause vasculitis and damage the endothelial cells, leading to multiple organ dysfunctions .The clinical manifestations of SLE include muco cutaneous, musculoskeletal system, cardiac, neurological, renal, hematologic, and vascular system involvement . Nail fold capillaroscopy (NFC) is a non-invasive easily repeatable technique and the best method for morphological analysis of nutritional capillaries in the nail fold area . Nail fold capillary changes are very common in patients with SLE. the major NFC pattern that has been reported in SLE patients was non-specific sub-types, followed by normal pattern and scleroderma pattern. In (SLE) patients are reported a large spectrum of antibodies, including the anti-ribonucleoproteins (RNP) antibodies These antibodies were linked to several clinical manifestations and prognostic in patients with SLE. Anti-U1-RNP antibodies are involved in both innate and adaptive immune responses during pathogenesis of connective tissue diseases 12. U1-RNP complex is an intra nuclear protein that converts pre-mRNA to mature RNA and constitutes three specific proteins A, C, and 70 kDa. High titer RNP antibodies are detected in MCTD patients and correlated with Clinical disease activity index and the frequent complication of pulmonary artery hypertension in those patients . It also has been found that NFC may detect subclinical microvascular changes in SLE in the presence of anti-U1-RNP antibodies and may facilitate early preventive therapy for major organ vasculopathy .
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- : Collected from Rheumatology, Rehabilitation and Physical Medicine Department, inpatient and outpatient clinics , Assiut University Hospital
Key inclusion criteria (1 listed)
- Adult SLE Patients who fulfilled the 2012 systemic lupus international collaborating clinics (SLICC) criteria
Key exclusion criteria (6 listed)
- SLE patient aged less than 18 yeares old.
- Individuals with other autoimmune diseases (rheumatoid arthritis dermatomyositis, scleroderma, mixed connective tissue disease).
- Congestive cardic failure and presence of clupping.
- Coexisting diabetes mellitus.
- history of smoking.
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 |
|---|---|---|
| nailfold capillaroscopyNailfold capillaroscopy (NFC) is a non-invasive easily repeatable technique and the best method for morphological analysis of nutritional capillaries in the nailfold area | Device | – |
Primary outcome
Frequency of nail fold capillary changes in SLE patient.
Time frame: baseline
capillary changes on nailfold capillaroscopy examination for SLE patients
3 secondary outcomes
1- Detection of patterns of nailfold capillary changes in SLE .
Time frame: baseline
2-Correlation of nailfold capillary changes in SLE patient and Anti-U1RNP antibodies.
Time frame: baseline
3-Correlation of nailfold capillary changes with SLE disease activity .
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2021.
- Background: PubMed 33758813Zhao T, Lin FA, Chen HP. Pattern of Nailfold Capillaroscopy in Patients With Systemic Lupus Erythematosus. Arch Rheumatol. 2020 Apr 20;35(4):568-574. doi: 10.46497/ArchRheumatol.2020.7763. eCollection 2020 Dec.
- Background: PubMed 34076720Chebbi PP, Goel R, Ramya J, Gowri M, Herrick A, Danda D. Nailfold capillaroscopy changes associated with anti-RNP antibodies in systemic lupus erythematosus. Rheumatol Int. 2022 Aug;42(8):1355-1361. doi: 10.1007/s00296-021-04894-4. Epub 2021 Jun 2.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of System Lupus Erythematosus, run by Assiut 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 6 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 14 Dec 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 Amera I. Abdel-Ghany, Dr (01003139319, amera_i95@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of nail fold capillary changes in SLE patient. (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 NCT05106998, which also lists 2 linked publications.
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 14 Dec 2021.