NFC Changes in SLE Patients and Its Correlation With Anti-U1RNPAntibodies and Disease Activity

• Conditions: System Lupus Erythematosus

• Registration Number: NCT05106998
• Lead Sponsor: Assiut University

Brief 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

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 Timeline

• Study First Submitted: 2021-10-25
• Study First Submitted QC: 2021-10-25
• Study First Posted: 2021-11-04
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-10
• Last Update Posted: 2021-12-14
• Study Start: 2022-03
• Primary Completion: 2022-11
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

• Adult SLE Patients who fulfilled the 2012 systemic lupus international collaborating clinics (SLICC) criteria

Exclusion Criteria

1. SLE patient aged less than 18 yeares old.
2. Individuals with other autoimmune diseases (rheumatoid arthritis dermatomyositis, scleroderma, mixed connective tissue disease).
3. Congestive cardic failure and presence of clupping.
4. Coexisting diabetes mellitus.
5. history of smoking.
6. Patients unable to co-operate for nailfold capillaroscopic examination

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of nail fold capillary changes in SLE patient.	baseline	capillary changes on nailfold capillaroscopy examination for SLE patients

Secondary Outcome Measures

Name	Time	Method
1- Detection of patterns of nailfold capillary changes in SLE .	baseline	to detect different patterns by nailfold capillaroscopy
2-Correlation of nailfold capillary changes in SLE patient and Anti-U1RNP antibodies.	baseline	relation of Anti U1 RNP antibodies and microvasculature as detected by NFC examination
3-Correlation of nailfold capillary changes with SLE disease activity .	baseline	relation of SLE disease activity and microvasculature as detected in NFC examination