Systemic Lupus ErythematosusBeliLESNCT04671706
Belimumab in Patients With Systemic Lupus Erythematosus
An observational study of Systemic Lupus Erythematosus, run by Grupo de Trabajo de Enfermedades Autoinmunes Sistémicas (GEAS) de la Fundación Española de Medicina at 1 site in Spain.
Trial summary
The BeliLES-GEAS project pretends to obtain an extensive data registry of patients with systemic lupus erythematosus (SLE). The main objective is to create a national SLE patients registry treated with belimumab to describe effectiveness and safety of intravenous (IV) or subcutaneous (SC) belimumab in patients with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus
- How many people
- 3,000 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2021to Dec 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Systemic Lupus Erythematosus
Who may be able to join
- Fulfillment of the 2019 EULAR/ACR classification criteria for SLE, SLICC classification criteria, 1997 American College of Rheumatology (ACR) revised criteria for SLE or patients with only 3 criteria but SLE diagnosed according to the clinical judgment of the treating physician.
- Age of 18 years or more.
- Having received at least one dose of intravenous or subcutaneous belimumab according the physician criteria regardless the clinical/immunological response.
- Signed informed consent.
Who cannot join
- 1) Negative from the patient to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effectiveness, Tolerability, and Safety of Belimumab in Patients With Systemic Lupus Erythematosus Treated at the Spanish Departments of Internal Medicine
The BeliLES-GEAS project pretends to obtain an extensive data registry of patients with systemic lupus erythematosus (SLE).
The main objective is to create a national SLE patients registry treated with belimumab to describe effectiveness and safety of intravenous (IV) or subcutaneous (SC) belimumab in patients with active SLE treated in the Spanish departments of Internal Medicine in a real-life setting. This research project aspires to cover the vast majority (if not the whole) of SLE patients treated with belimumab in all of the Spanish Departments of Internal Medicine.
Read the detailed description
The goal of BeliLES-GEAS registry is to create an observational, non-randomized, non-controlled, national multicenter prospective and retrospective cohort with the aim to explore the real performance, with its lights and shadows, of Belimumab, either IV or SC, in a real-world population of lupus patients.
The intention is to perform a longer-term follow up, so that the measure of hard outcomes, such as improvement in mortality, could be feasible, but also reliable data regarding the safety profile could be recorded.
In order to achieve that, the following variables will be included: individual criteria as part of 2019 EULAR/ACR, SLICC or ACR 1997 classification criteria, gender, age at diagnosis, age at symptoms onset, duration of the disease, age at first Belimumab administration, mean time of follow-up prior to, and from Belimumab administration, complete medical history including other systemic autoimmune diseases, type/s of organ/systems affected by SLE, prior immunosuppressants received, number of flares 2 years prior Belimumab onset, number of medical visits, number of days of sick leave, type of disease, treatment and laboratory data. As a measure of damage, Systemic Lupus International Collaborating Clinics-Damage Index (SLICC-DI) score will be calculated at baseline and at 12, 18, 24 months and yearly of follow-up. All centers will be requested to provide the SLICC-DI calculated annually of the last five years before the initiation of belimumab, when available.
The efficacy will be evaluated as time to reach any of the definition of remission included in the DORIS (definitions of remission in SLE) consensus, or LLDAs (lupus low disease activity state). Regarding the safety of Belimumab in real-world setting, it will be defined and evaluated by documenting adverse events.
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Systemic lupus erythematosus, SLE, Belimumab
- Medical subject headings
- Lupus Erythematosus, Systemic
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease activity, clinical outcomes, and describe overall patterns of SLE care
Study endpoints are clinically recognized (and objectively confirmed). Additional endpoints will be the identification of predictors of response in our patients
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study startJan 2021 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Time perspective
- Other
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Grupo de Trabajo de Enfermedades Autoinmunes Sistémicas (GEAS) de la Fundación Española de Medicina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gerard Espinosa, Study chair, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04671706
- Sponsor's protocol ID
- BeliLES
- Acronym
- BeliLES
- Status last verified
- Dec 2020
- First submitted
- 11 Dec 2020
- Last updated
- 17 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness, Tolerability, and Safety of Belimumab in Patients With Systemic Lupus Erythematosus Treated at the Spanish Departments of Internal Medicine
- ClinicalTrials.gov ID
- NCT04671706
- Acronym / sponsor ID
- BeliLES / BeliLES
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Systemic lupus erythematosus, SLE, Belimumab
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Grupo de Trabajo de Enfermedades Autoinmunes Sistémicas (GEAS) de la Fundación Española de MedicinaUniversity, hospital or other
- Study start
- Jan 2021 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 17 Dec 2020 (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.
The BeliLES-GEAS project pretends to obtain an extensive data registry of patients with systemic lupus erythematosus (SLE).
The main objective is to create a national SLE patients registry treated with belimumab to describe effectiveness and safety of intravenous (IV) or subcutaneous (SC) belimumab in patients with active SLE treated in the Spanish departments of Internal Medicine in a real-life setting. This research project aspires to cover the vast majority (if not the whole) of SLE patients treated with belimumab in all of the Spanish Departments of Internal Medicine.
Detailed description
The goal of BeliLES-GEAS registry is to create an observational, non-randomized, non-controlled, national multicenter prospective and retrospective cohort with the aim to explore the real performance, with its lights and shadows, of Belimumab, either IV or SC, in a real-world population of lupus patients.
The intention is to perform a longer-term follow up, so that the measure of hard outcomes, such as improvement in mortality, could be feasible, but also reliable data regarding the safety profile could be recorded.
In order to achieve that, the following variables will be included: individual criteria as part of 2019 EULAR/ACR, SLICC or ACR 1997 classification criteria, gender, age at diagnosis, age at symptoms onset, duration of the disease, age at first Belimumab administration, mean time of follow-up prior to, and from Belimumab administration, complete medical history including other systemic autoimmune diseases, type/s of organ/systems affected by SLE, prior immunosuppressants received, number of flares 2 years prior Belimumab onset, number of medical visits, number of days of sick leave, type of disease, treatment and laboratory data. As a measure of damage, Systemic Lupus International Collaborating Clinics-Damage Index (SLICC-DI) score will be calculated at baseline and at 12, 18, 24 months and yearly of follow-up. All centers will be requested to provide the SLICC-DI calculated annually of the last five years before the initiation of belimumab, when available.
The efficacy will be evaluated as time to reach any of the definition of remission included in the DORIS (definitions of remission in SLE) consensus, or LLDAs (lupus low disease activity state). Regarding the safety of Belimumab in real-world setting, it will be defined and evaluated by documenting adverse events.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Systemic Lupus Erythematosus
Key inclusion criteria (4 listed)
- Fulfillment of the 2019 EULAR/ACR classification criteria for SLE, SLICC classification criteria, 1997 American College of Rheumatology (ACR) revised criteria for SLE or patients with only 3 criteria but SLE diagnosed according to the clinical judgment of the treating physician.
- Age of 18 years or more.
- Having received at least one dose of intravenous or subcutaneous belimumab according the physician criteria regardless the clinical/immunological response.
- Signed informed consent.
Key exclusion criteria (1 listed)
- 1) Negative from the patient to participate in the study.
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
Disease activity, clinical outcomes, and describe overall patterns of SLE care
Time frame: 2 years
Study endpoints are clinically recognized (and objectively confirmed). Additional endpoints will be the identification of predictors of response in our patients
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Individual participant dataSharing planned: No
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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.
Gerard Espinosa study chair
Hospital Clinic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus Erythematosus, run by Grupo de Trabajo de Enfermedades Autoinmunes Sistémicas (GEAS) de la Fundación Española de Medicina at 1 site in Spain.
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 4 inclusion and 1 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: opening soon, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Almudena Sanchez Ledesma (0034915357183, almudena.sanchez@shmedical.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease activity, clinical outcomes, and describe overall patterns of SLE care (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Dec 2020.