BAFF and APRIL and RESPONSE TO BELIMUMAB in SLE

NCT ID: NCT03919643

Last Updated: 2019-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-01

Study Completion Date

2020-07-01

Brief Summary

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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

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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.

Conditions

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Systemic Lupus Erythematosus BAFF Polymorphism

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Study Groups

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SLE patients with nephritis

No intervention. Peripheral blood and urine samples will be obtained

No interventions assigned to this group

SLE patients with without nephritis

No intervention. Peripheral blood and urine samples will be obtained

No interventions assigned to this group

Healthy controls (blood donors)

No intervention. Peripheral blood and urine samples will be obtained

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Francisca González- Escribano, PhD

Role: CONTACT

0034955012144

Clara Rosso-Fernández, MD-PhD

Role: CONTACT

References

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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.

Reference Type DERIVED
PMID: 35780200 (View on PubMed)

Other Identifiers

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BAFF

Identifier Type: -

Identifier Source: org_study_id

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