Trials / Completed
CompletedNCT03063281
Anti-ficolin-2 Autoantibodies in Lupus Nephritis
Association Between the Presence of Autoantibodies Targeting Ficolin-2 and Active Nephritis in Patients With Systemic Lupus Erythematosus
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 213 (actual)
- Sponsor
- University Hospital, Grenoble · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Accepted
Summary
Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by the production of multiple autoantibodies. The prevalence and significance of antibodies against Ficolin-2 have not been yet investigated. The aims of this study were to determine the prevalence of anti-ficolin-2 antibodies among SLE patients and to investigate their potential as diagnostic and/or prognostic biomarkers in SLE. This study is a secondary phase of a serum sample analysis done in early 2015 in order to determine the prevalence of anti-ficolin-2 antibodies among the same cohort as the previously declared study (ClinicalTrials.gov ID: NCT02625831; Unique Protocol ID: 1841851v0). In this retrospective study, clinical data were obtained from medical files and blood samples were selected from preexisting biological collection. SLE patients (n=165) were informed and did not objected, they were matched to healthy controls (n=48). Disease activity was determined according to the SLEDAI score. Anti-ficolin-2 antibodies levels were measured in sera by ELISA and correlated to previously obtained Anti-ficolin-3, Anti-ficolin-2, anti-dsDNA and anti-C1q antibodies levels. The titer of anti-ficolin-2 antibodies was correlated with the SLEDAI score (p\<0.0001). The presence of anti-ficolin-2 antibodies was associated with anti-ficolin-3 antibodies, anti-C1q and anti-dsDNA antibodies. Interestingly, the combination of anti-ficolin-3, anti-ficolin-2 and anti-C1q antibodies demonstrated higher specificity than any other traditional biomarker. These results suggest that anti-ficolin-3 and anti-ficolin-2 antibodies could be useful for the diagnosis of active nephritis in SLE patients.
Detailed description
For this retrospective study, the well written brief summary should be sufficient.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | BIological analysis | Biological analysis : ficolin-2 et anti-ficolin-2 antibodies |
Timeline
- Start date
- 2012-11-01
- Primary completion
- 2013-05-01
- Completion
- 2015-05-01
- First posted
- 2017-02-24
- Last updated
- 2017-02-24
Source: ClinicalTrials.gov record NCT03063281. Inclusion in this directory is not an endorsement.