Systemic Lupus Erythematosus Clinical Trial
Official title:
Validation of the Assay of Circulating Antibodies Against Glomerular Neo-autoantigens as a Surrogate Biomarker of the Development of Lupus Nephritis
The purpose of this study is to clarify the mechanisms involved in the formation and
glomerular deposition of immune complexes in lupus nephritis.
The determination of an antibody pattern specific for systemic lupus erythematosus and lupus
nephritis may also have a role in predicting disease progression in patients with systemic
lupus erythematosus without renal impairment. As for the patients enrolled in the study, the
determination of their antibody patterns may contribute to a more targeted and personalized
treatment, allowing a prediction of disease progression and the introduction of early
targeted treatments, in order to block the onset and/or progression of renal damage.
Prospective multicenter study on the validity of levels of circulating antibodies to
glomerular neo-autoantigens (alpha-enolase and annexin AI) and implantable antigens
(anti-DNA, histone, istone3, istone4, C1q) as a surrogate biomarker for the diagnosis of
lupus nephritis.
The study will involve the collection of serum from patients with lupus nephritis at onset
and during subsequent follow-up at 6, 12, 24 and 36 months for the titration of circulating
autoantibodies.
As a control the investigators will use the sera of patients with systemic lupus
erythematosus without nephropathy, collected at the same time intervals.
The investigators will also assess the antibody positivity in groups of patients with
rheumatologic disease similar to lupus (rheumatoid arthritis) and in patients with autoimmune
nephropathy without extrarenal clinical signs.
Regarding patients with systemic lupus erythematosus the investigators will collect sera of
both incident and prevalent patients in order to monitor changes in antibody levels in
conjunction with the development of renal disease.
Clinical tests (renal function, complete blood count, C reactive protein (CRP), ANA, native
DNA (nDNA), urine analysis) will be performed at 6, 12, 24 and 36 months and the surplus of
blood samples will be used to create the serum bank of the study.
Samples will be collected in the pediatric nephrology of Giannina Gaslini Children Hospital,
Genoa (coordinator centre) and in 5 rheumatological (Genoa, Pisa, Pavia, Padova, Brescia) and
6 nephrological (Milan, Genoa, Parma, Brescia, Bologna and Reggio Emilia) italian adults
departments .
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT03843125 -
A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE)
|
Phase 3 | |
| Recruiting |
NCT05698173 -
Systemic Lupus Erythematosus and Accelerated Aging
|
N/A | |
| Active, not recruiting |
NCT01649765 -
Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy
|
Phase 2 | |
| Recruiting |
NCT05704153 -
Modelling and Control of Non-invasive Vagus Nerve Stimulation for Autoimmune Diseases (1A)
|
N/A | |
| Completed |
NCT05048238 -
Evaluation of Tofacitinib in Prevention of Photosensitivity in Lupus
|
Phase 1 | |
| Recruiting |
NCT06056778 -
The Prevalence Evaluation of Systemic Lupus Erythematosus in Russian Patients With Reproductive Issues (PRISMA)
|
||
| Completed |
NCT04358302 -
Individual Patient Exposure and Response in Pediatric Lupus
|
N/A | |
| Completed |
NCT03802578 -
The Impact of Exercise on Hand Function, Daily Activities Performance and Quality of Life of SLE' Patients
|
N/A | |
| Completed |
NCT02554019 -
Proof-of-Concept Study With BT063 in Subjects With Systemic Lupus Erythematosus
|
Phase 2 | |
| Recruiting |
NCT04835883 -
Exploring the Efficacy and Safety of CS20AT04 (Allogenic Bone Marrow-Derived Stem Cell) in Systemic Lupus Erythematosus Patients
|
Phase 2 | |
| Terminated |
NCT02665364 -
Phase IIb Study of IFN-K in Systemic Lupus Erythematosus
|
Phase 2 | |
| Completed |
NCT00278538 -
Cyclophosphamide and Rabbit Antithymocyte Globulin (rATG)/Rituximab in Patients With Systemic Lupus Erythematosus
|
Phase 2 | |
| Completed |
NCT00069342 -
Health Beliefs and Health Behaviors Among Minorities With Rheumatic Diseases
|
||
| Completed |
NCT03252587 -
An Investigational Study to Evaluate BMS-986165 in Participants With Systemic Lupus Erythematosus
|
Phase 2 | |
| Terminated |
NCT02066311 -
Nelfinavir in Systemic Lupus Erythematosus
|
Phase 2 | |
| Recruiting |
NCT01892748 -
Cholecalciferol Supplementation on Disease Activity, Fatigue and Bone Mass on Juvenile Systemic Lupus Erythematosus.
|
N/A | |
| Terminated |
NCT01689025 -
An Investigation of Safety and Tolerability of NNC0114-0006 in Subjects With Systemic Lupus Erythematosus (SLE)
|
Phase 1 | |
| Unknown status |
NCT01712529 -
Physical Exercise, Endothelial Function and Progenitor Endothelial Cells in Systemic Lupus Erythematosus Patients
|
N/A | |
| Completed |
NCT01475149 -
Effect of HCQ on AnxA5 Resistance Assay in Antiphospholipid (aPL) Positive Patients With and Without Systemic Lupus Erythematosus (SLE)
|
N/A | |
| Completed |
NCT00962832 -
A Study to Evaluate the Efficacy and Safety of Rontalizumab in Patients With Moderately to Severely Active Systemic Lupus Erythematosus
|
Phase 2 |