Systemic Lupus ErythematosusBAFFNCT03919643
BAFF and APRIL and RESPONSE TO BELIMUMAB in SLE
An observational study of Systemic Lupus Erythematosus and BAFF Polymorphism, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Systemic Lupus Erythematosus, BAFF Polymorphism
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2019to 1 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: SLE (Sistemic Lupus Disease) with and without nephritis and healthy controls
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet.
Clara Rosso-Fernández, MD-PhD contact
About this study
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
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.
Read the 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.
- Conditions
- Systemic Lupus Erythematosus, BAFF Polymorphism
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SLE patients with nephritis | No intervention. Peripheral blood and urine samples will be obtained | |
| SLE patients with without nephritis | No intervention. Peripheral blood and urine samples will be obtained | |
| Healthy controls (blood donors) | No intervention. Peripheral blood and urine samples will be obtained |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Quantify physiological parameters (levels of BAFF and APRIL) in serum and urine of patients and controls by ELISA.
Measured: from data of Informed consent form signature to finish of follow-up (1 Year)
Establish the influence of certain polymorphisms in the levels of expression of different transcripts and proteins.
Determine the expression levels of different physiological parameters (BAFF and APRIL transcripts) in peripheral blood mononuclear cells from patients and controls.
Measured: from data of Informed consent form signature to finish of follow-up (1 Year)
Correlate the transcript and protein levels with clinical manifestations and disease activity.
Quantify anti-dsDNA levels recording clinical symptoms and SLE-DAI (Systemic Lupus Erythematosus Disease Activity Index)
Measured: from data of Informed consent form signature to finish of follow-up (1 Year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2019
- Study start1 May 2019 (estimated)
- Primary completion1 May 2020 (estimated)
- Study completion1 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03919643
- Sponsor's protocol ID
- BAFF
- Acronym
- BAFF
- Status last verified
- Apr 2019
- First submitted
- 14 Feb 2019
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sharing the data collected and analysed with the scientific community by publication
Publications
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.
PubMed 35780200
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03919643
- Acronym / sponsor ID
- BAFF / BAFF
- Conditions
- Systemic Lupus Erythematosus, BAFF Polymorphism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
- Study start
- 1 May 2019 (estimated)
- Primary completion
- 1 May 2020 (estimated)
- Study completion
- 1 Jul 2020 (estimated)
- First posted
- 18 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SLE patients with nephritis | – | –No intervention. Peripheral blood and urine samples will be obtained |
| SLE patients with without nephritis | – | –No intervention. Peripheral blood and urine samples will be obtained |
| Healthy controls (blood donors) | – | –No intervention. Peripheral blood and urine samples will be obtained |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- SLE (Sistemic Lupus Disease) with and without nephritis and healthy controls
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: from data of Informed consent form signature to finish of follow-up (1 Year)
Quantify physiological parameters (levels of BAFF and APRIL) in serum and urine of patients and controls by ELISA.
Establish the influence of certain polymorphisms in the levels of expression of different transcripts and proteins.
Time frame: from data of Informed consent form signature to finish of follow-up (1 Year)
Determine the expression levels of different physiological parameters (BAFF and APRIL transcripts) in peripheral blood mononuclear cells from patients and controls.
Correlate the transcript and protein levels with clinical manifestations and disease activity.
Time frame: from data of Informed consent form signature to finish of follow-up (1 Year)
Quantify anti-dsDNA levels recording clinical symptoms and SLE-DAI (Systemic Lupus Erythematosus Disease Activity Index)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
- Derived from this study: PubMed 35780200Ortiz-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.
- Individual participant dataSharing planned: Yes. Sharing the data collected and analysed with the scientific community by publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clara Rosso-Fernández, MD-PhD contact
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus Erythematosus and BAFF Polymorphism, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francisca González- Escribano, PhD (0034955012144, mariaf.gonzalez.sspa@juntadeandalucia.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: from data of Informed consent form signature to finish of follow-up (1 Year)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03919643, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2019.