Clinical trial NCT03919643: BAFF and APRIL and RESPONSE TO BELIMUMAB in SLE
Official title: B Cell Activating Factor Belonging to the TNF (Tumor Necrosis Factor) Family (BAFF) and a Proliferation-inducing Ligand (APRIL) in Patients With Systemic Lupus Erythematosus: Investigating Biomarkers for the Response to the Belimumab Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Systemic Lupus Erythematosus
BAFF Polymorphism
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor class: OTHER
First posted: 2019-04-18
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: SLE (Sistemic Lupus Disease) with and without nephritis and healthy controls

Brief summary: This project is intended to identify the routes on which BAFF and APRIL act in order to detect possible future candidates to Belimumab treatment among patients diagnosed of SLE.

Detailed description: DESIGN Establish the influence of certain polymorphisms in the levels of expression of different transcripts and proteins.

Quantify the levels of B cell activating factor belonging to the TNF family (BAFF) and a proliferation-inducing ligand (APRIL) in serum and urine of patients and controls by Enzyme-Linked Immunosorbent Assay (ELISA). BAFF Determine the expression levels of different BAFF and APRIL transcripts in peripheral blood mononuclear cells from patients and controls using a digital PCR (polymerase chain reaction) system.

Compare distribution of gene polymorphisms in BAFF and APRIL in patients and controls. by sequencing the exome of the ligand and receptor genes using next generation sequencing (NGS).

Correlate the transcript and protein levels with clinical manifestations and disease activity.

The results of the quantification of anti- double-stranded deoxyribonucleic acid.(dsDNA) antibody levels tests will be recorded together with those demographics, clinical-epidemiological and response to the treatment.data.

Eligibility criteria: Inclusion criteria

* Women18-60 years old
* For patients only treated with conventional drugs (without immunosuppressive or biological treatment )
* For Healthy controls: no autoimmune diseases (blood donors) diagnoses

Primary outcomes:
measure: Improve knowledge of B Cell activating factor belonging to the TNF (Tumor necrosis factor) family (BAAF) system in order to identify those SLE (Systemic Lupus Erythematous) patients that are candidate for treatment with anti-BAFF.
timeFrame: from data of Informed consent form signature to finish of follow-up (1 Year)
measure: Establish the influence of certain polymorphisms in the levels of expression of different transcripts and proteins.
timeFrame: from data of Informed consent form signature to finish of follow-up (1 Year)
measure: Correlate the transcript and protein levels with clinical manifestations and disease activity.
timeFrame: from data of Informed consent form signature to finish of follow-up (1 Year)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Ortiz-Aljaro P, Montes-Cano MA, Garcia-Lozano JR, Aquino V, Carmona R, Perez-Florido J, Garcia-Hernandez FJ, Dopazo J, Gonzalez-Escribano MF. Protein and functional isoform levels and genetic variants of the BAFF and APRIL pathway components in systemic lupus erythematosus. Sci Rep. 2022 Jul 2;12(1):11219. doi: 10.1038/s41598-022-15549-0.