SLE - Systemic Lupus ErythematosusNCT07056621
Does Belimumab Modify the Natural History of SLE? A Propensity Score-matched, Real-world Study
An observational study of SLE - Systemic Lupus Erythematosus, run by Biomedical Research Foundation, Academy of Athens at 1 site in Greece.
Trial summary
This will be a combined retrospective and prospective cohort study, that will evaluate the incidence of de novo Systemic Lupus Erythematosus major organ manifestations (defined as BILAG A flares) in patients receiving belimumab (Arm A) and compare it to 2 standard-of-care groups (SoC) (Arm B: patients on SoC; Arm C… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SLE - Systemic Lupus Erythematosus
- How many people
- 684 participants
- Where
- 1 siteGreece
- Study dates
- 30 Jun 2025to Jun 2026
- How long will I take part?
- 1 Year
- 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: Adult systemic lupus erythematosus patients, receiving belimumab (Arm A) or standard-of-care treatment (Arms B and C).
Who may be able to join
- Systemic lupus erythematosus classification according to the Systemic Lupus International Collaborating Clinics (SLICC) criteria
- Age ≥ 18 years old
- Time of follow-up ≥ 6 months
- Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) ≥ 4
- Physician Global Assessment (PGA) visual analogue score > 1
Who cannot join
- Patients with incomplete medical records or missing key variables
- Patients with concomitant autoimmune disorders (excluding thyroid disease)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
University Hospital 'Attikon'
Athens, Attica, 12462
Dimitrios T Boumpas, Professor in Medicine, 00306937212025, boumpasd@uoc.gr
Dimitrios T Boumpas, Professor in Medicine
About this study
This will be a combined retrospective and prospective cohort study, that will evaluate the incidence of de novo Systemic Lupus Erythematosus major organ manifestations (defined as BILAG A flares) in patients receiving belimumab (Arm A) and compare it to 2 standard-of-care groups (SoC) (Arm B: patients on SoC; Arm C: patients on SoC followed-up up to May 1st 2014, the first date where belimumab was available in Greece).
The investigators will utilize survival analysis methods (Kaplan-Meier survival curves and Cox regression) and mixed effects longitudinal analyses. Additionally, the investigators will employ propensity score matching and/or inverse probability of treatment weighting, to create balanced cohorts and reduce bias.
Read the detailed description
Belimumab (BEL) has been used for the treatment of SLE for over 10 years, with clear evidence for a beneficial effect in reduction of disease activity and frequency of flares, as well as prevention of damage accrual.
Whether BEL may also result in prevention of incident, major organ involvement in patients with SLE is less clear. A recent post-hoc analysis of the BLISS trials suggested that BEL (although at the low, rather than standard-dose) reduced the rate of de novo renal flares (defined by BILAG) compared to standard-of-care but real-life data are scarce. Importantly, data on the ability of belimumab to decrease major neuropsychiatric events in SLE such as strokes, seizures and cognitive dysfunction or other severe manifestations such as severe hematologic or cardiopulmonary disease is not known.
To this end, the investigators propose a propensity score-matched, real-world, with the use of longitudinal data from large patient cohorts and time-to-event analyses. Given the non-experimental setting of this study, the investigators will also employ propensity score matching (PSM), to create balanced cohorts of BEL-treated and non-BEL-treated patients and reduce bias in estimating treatment efficacy.
The study will consist of 3 arms, as follows: Arm A: patients on treatment with belimumab; Arm B: patients on standard-of-care (SoC) treatment from May 1st 2014 onwards; Arm C: a historical cohort of patients on SoC followed-up up to May 1st 2014, the first date where belimumab was available in Greece.
- Conditions
- SLE - Systemic Lupus Erythematosus
- Keywords
- SLE, belimumab, bilag
- 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 |
|---|---|---|
| Group A: Belimumab | Group A will consist of patients under treatment with belimumab. | |
| Group B: Standard-of-care (follow-up after May 1st 2014) | Group B will consist of patients on standar-of-care SLE treatment, who were followed-up after May 1st 2014 (the first date where belimumab was available in Greece). | |
| Group C: Standar-of-care (follow-up before May 1st 2014) | Group C will consist of a historical cohort of patients under standar-of-care, followed-up before May 1st 2014 (the first date where belimumab was available in Greece). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bilag A flare
Major organ systemic lupus erythematosus manifestations as defined by the BILAG (British Isles Lupus Assessment Group) index (BILAG A flare)
Measured: From enrollment to the end of treatment (expected follow-up duration 1-4 years).
Secondary outcomes (1)
SLICC/ACR Damage Index
Systemic Lupus International Collaborating Clinics, ACR/American College of Rheumatology (SLICC/ACR) Damage Index (SDI)
Measured: From enrollment to the end of treatment (expected follow-up duration 1-4 years).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start30 Jun 2025
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for SLE - 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
- Cohort
- Time perspective
- Other
- Enrolment
- 684 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Biomedical Research Foundation, Academy of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DIMITRIOS BOUMPAS, Biomedical Research Foundation, Academy of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07056621
- Sponsor's protocol ID
- 224080
- Status last verified
- Jun 2025
- First submitted
- 30 Jun 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators are not currently planning on sharing Individual participant data (IPD). This decision is based on the fact the investigators have not made specific agreements with our hospital's IRB about individual participant data sharing. Study results will be disseminated through peer-reviewed publications, which will provide comprehensive findings while maintaining participant confidentiality. However, upon reasonable requests from qualified researchers for legitimate scientific purposes, the investigators may consider sharing de-identified IPD on a case-by-case basis, after approval by our IRB.
Publications
Fanouriakis A, Adamichou C, Koutsoviti S, Panopoulos S, Staveri C, Klagou A, Tsalapaki C, Pantazi L, Konsta S, Mavragani CP, Dimopoulou D, Ntali S, Katsikas G, Boki KA, Vassilopoulos D, Konstantopoulou P, Liossis SN, Elezoglou A, Tektonidou M, Sidiropoulos P, Erden A, Sfikakis PP, Bertsias G, Boumpas DT. Low disease activity-irrespective of serologic status at baseline-associated with reduction of corticosteroid dose and number of flares in patients with systemic lupus erythematosus treated with belimumab: A real-life observational study. Semin Arthritis Rheum. 2018 Dec;48(3):467-474. doi: 10.1016/j.semarthrit.2018.02.014. Epub 2018 Feb 23.
PubMed 29555348Nikoloudaki M, Nikolopoulos D, Koutsoviti S, Flouri I, Kapsala N, Repa A, Katsimbri P, Theotikos E, Pitsigavdaki S, Pateromichelaki K, Bertsias A, Elezoglou A, Sidiropoulos P, Fanouriakis A, Boumpas D, Bertsias G. Clinical response trajectories and drug persistence in systemic lupus erythematosus patients on belimumab treatment: A real-life, multicentre observational study. Front Immunol. 2023 Jan 4;13:1074044. doi: 10.3389/fimmu.2022.1074044. eCollection 2022.
PubMed 36685524Iaccarino L, Bettio S, Reggia R, Zen M, Frassi M, Andreoli L, Gatto M, Piantoni S, Nalotto L, Franceschini F, Larosa M, Fredi M, Punzi L, Tincani A, Doria A. Effects of Belimumab on Flare Rate and Expected Damage Progression in Patients With Active Systemic Lupus Erythematosus. Arthritis Care Res (Hoboken). 2017 Jan;69(1):115-123. doi: 10.1002/acr.22971. Epub 2016 Nov 18.
PubMed 27390293Bartels C, Bell C, Rosenthal A, Shinki K, Bridges A. Decline in rheumatoid vasculitis prevalence among US veterans: a retrospective cross-sectional study. Arthritis Rheum. 2009 Sep;60(9):2553-7. doi: 10.1002/art.24775.
PubMed 19714622van Vollenhoven R, Askanase AD, Bomback AS, Bruce IN, Carroll A, Dall'Era M, Daniels M, Levy RA, Schwarting A, Quasny HA, Urowitz MB, Zhao MH, Furie R. Conceptual framework for defining disease modification in systemic lupus erythematosus: a call for formal criteria. Lupus Sci Med. 2022 Mar;9(1):e000634. doi: 10.1136/lupus-2021-000634.
PubMed 35346982Fanouriakis A, Kostopoulou M, Andersen J, Aringer M, Arnaud L, Bae SC, Boletis J, Bruce IN, Cervera R, Doria A, Dorner T, Furie RA, Gladman DD, Houssiau FA, Ines LS, Jayne D, Kouloumas M, Kovacs L, Mok CC, Morand EF, Moroni G, Mosca M, Mucke J, Mukhtyar CB, Nagy G, Navarra S, Parodis I, Pego-Reigosa JM, Petri M, Pons-Estel BA, Schneider M, Smolen JS, Svenungsson E, Tanaka Y, Tektonidou MG, Teng YO, Tincani A, Vital EM, van Vollenhoven RF, Wincup C, Bertsias G, Boumpas DT. EULAR recommendations for the management of systemic lupus erythematosus: 2023 update. Ann Rheum Dis. 2024 Jan 2;83(1):15-29. doi: 10.1136/ard-2023-224762.
PubMed 37827694
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Belimumab Modify the Natural History of SLE? A Propensity Score-matched, Real-world Study
- ClinicalTrials.gov ID
- NCT07056621
- Acronym / sponsor ID
- 224080
- Conditions
- SLE - Systemic Lupus Erythematosus
- Keywords
- SLE, belimumab, bilag
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 684 participants (estimated)
- Lead sponsor
- Biomedical Research Foundation, Academy of AthensUniversity, hospital or other
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 9 Jul 2025 (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 will be a combined retrospective and prospective cohort study, that will evaluate the incidence of de novo Systemic Lupus Erythematosus major organ manifestations (defined as BILAG A flares) in patients receiving belimumab (Arm A) and compare it to 2 standard-of-care groups (SoC) (Arm B: patients on SoC; Arm C: patients on SoC followed-up up to May 1st 2014, the first date where belimumab was available in Greece).
The investigators will utilize survival analysis methods (Kaplan-Meier survival curves and Cox regression) and mixed effects longitudinal analyses. Additionally, the investigators will employ propensity score matching and/or inverse probability of treatment weighting, to create balanced cohorts and reduce bias.
Detailed description
Belimumab (BEL) has been used for the treatment of SLE for over 10 years, with clear evidence for a beneficial effect in reduction of disease activity and frequency of flares, as well as prevention of damage accrual.
Whether BEL may also result in prevention of incident, major organ involvement in patients with SLE is less clear. A recent post-hoc analysis of the BLISS trials suggested that BEL (although at the low, rather than standard-dose) reduced the rate of de novo renal flares (defined by BILAG) compared to standard-of-care but real-life data are scarce. Importantly, data on the ability of belimumab to decrease major neuropsychiatric events in SLE such as strokes, seizures and cognitive dysfunction or other severe manifestations such as severe hematologic or cardiopulmonary disease is not known.
To this end, the investigators propose a propensity score-matched, real-world, with the use of longitudinal data from large patient cohorts and time-to-event analyses. Given the non-experimental setting of this study, the investigators will also employ propensity score matching (PSM), to create balanced cohorts of BEL-treated and non-BEL-treated patients and reduce bias in estimating treatment efficacy.
The study will consist of 3 arms, as follows: Arm A: patients on treatment with belimumab; Arm B: patients on standard-of-care (SoC) treatment from May 1st 2014 onwards; Arm C: a historical cohort of patients on SoC followed-up up to May 1st 2014, the first date where belimumab was available in Greece.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A: Belimumab | – | –Group A will consist of patients under treatment with belimumab. |
| Group B: Standard-of-care (follow-up after May 1st 2014) | – | –Group B will consist of patients on standar-of-care SLE treatment, who were followed-up after May 1st 2014 (the first date where belimumab was available in Greece). |
| Group C: Standar-of-care (follow-up before May 1st 2014) | – | –Group C will consist of a historical cohort of patients under standar-of-care, followed-up before May 1st 2014 (the first date where belimumab was available in Greece). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult systemic lupus erythematosus patients, receiving belimumab (Arm A) or standard-of-care treatment (Arms B and C).
Key inclusion criteria (5 listed)
- Systemic lupus erythematosus classification according to the Systemic Lupus International Collaborating Clinics (SLICC) criteria
- Age ≥ 18 years old
- Time of follow-up ≥ 6 months
- Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) ≥ 4
- Physician Global Assessment (PGA) visual analogue score > 1
Key exclusion criteria (2 listed)
- Patients with incomplete medical records or missing key variables
- Patients with concomitant autoimmune disorders (excluding thyroid disease)
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
Bilag A flare
Time frame: From enrollment to the end of treatment (expected follow-up duration 1-4 years).
Major organ systemic lupus erythematosus manifestations as defined by the BILAG (British Isles Lupus Assessment Group) index (BILAG A flare)
1 secondary outcome
SLICC/ACR Damage Index
Time frame: From enrollment to the end of treatment (expected follow-up duration 1-4 years).
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 8 Sep 2025.
- Background: PubMed 29555348Fanouriakis A, Adamichou C, Koutsoviti S, Panopoulos S, Staveri C, Klagou A, Tsalapaki C, Pantazi L, Konsta S, Mavragani CP, Dimopoulou D, Ntali S, Katsikas G, Boki KA, Vassilopoulos D, Konstantopoulou P, Liossis SN, Elezoglou A, Tektonidou M, Sidiropoulos P, Erden A, Sfikakis PP, Bertsias G, Boumpas DT. Low disease activity-irrespective of serologic status at baseline-associated with reduction of corticosteroid dose and number of flares in patients with systemic lupus erythematosus treated with belimumab: A real-life observational study. Semin Arthritis Rheum. 2018 Dec;48(3):467-474. doi: 10.1016/j.semarthrit.2018.02.014. Epub 2018 Feb 23.
- Background: PubMed 36685524Nikoloudaki M, Nikolopoulos D, Koutsoviti S, Flouri I, Kapsala N, Repa A, Katsimbri P, Theotikos E, Pitsigavdaki S, Pateromichelaki K, Bertsias A, Elezoglou A, Sidiropoulos P, Fanouriakis A, Boumpas D, Bertsias G. Clinical response trajectories and drug persistence in systemic lupus erythematosus patients on belimumab treatment: A real-life, multicentre observational study. Front Immunol. 2023 Jan 4;13:1074044. doi: 10.3389/fimmu.2022.1074044. eCollection 2022.
- Background: PubMed 27390293Iaccarino L, Bettio S, Reggia R, Zen M, Frassi M, Andreoli L, Gatto M, Piantoni S, Nalotto L, Franceschini F, Larosa M, Fredi M, Punzi L, Tincani A, Doria A. Effects of Belimumab on Flare Rate and Expected Damage Progression in Patients With Active Systemic Lupus Erythematosus. Arthritis Care Res (Hoboken). 2017 Jan;69(1):115-123. doi: 10.1002/acr.22971. Epub 2016 Nov 18.
- Background: PubMed 19714622Bartels C, Bell C, Rosenthal A, Shinki K, Bridges A. Decline in rheumatoid vasculitis prevalence among US veterans: a retrospective cross-sectional study. Arthritis Rheum. 2009 Sep;60(9):2553-7. doi: 10.1002/art.24775.
- Background: PubMed 35346982van Vollenhoven R, Askanase AD, Bomback AS, Bruce IN, Carroll A, Dall'Era M, Daniels M, Levy RA, Schwarting A, Quasny HA, Urowitz MB, Zhao MH, Furie R. Conceptual framework for defining disease modification in systemic lupus erythematosus: a call for formal criteria. Lupus Sci Med. 2022 Mar;9(1):e000634. doi: 10.1136/lupus-2021-000634.
- Background: PubMed 37827694Fanouriakis A, Kostopoulou M, Andersen J, Aringer M, Arnaud L, Bae SC, Boletis J, Bruce IN, Cervera R, Doria A, Dorner T, Furie RA, Gladman DD, Houssiau FA, Ines LS, Jayne D, Kouloumas M, Kovacs L, Mok CC, Morand EF, Moroni G, Mosca M, Mucke J, Mukhtyar CB, Nagy G, Navarra S, Parodis I, Pego-Reigosa JM, Petri M, Pons-Estel BA, Schneider M, Smolen JS, Svenungsson E, Tanaka Y, Tektonidou MG, Teng YO, Tincani A, Vital EM, van Vollenhoven RF, Wincup C, Bertsias G, Boumpas DT. EULAR recommendations for the management of systemic lupus erythematosus: 2023 update. Ann Rheum Dis. 2024 Jan 2;83(1):15-29. doi: 10.1136/ard-2023-224762.
- Individual participant dataSharing planned: No. The investigators are not currently planning on sharing Individual participant data (IPD). This decision is based on the fact the investigators have not made specific agreements with our hospital's IRB about individual participant data sharing. Study results will be disseminated through peer-reviewed publications, which will provide comprehensive findings while maintaining participant confidentiality. However, upon reasonable requests from qualified researchers for legitimate scientific purposes, the investigators may consider sharing de-identified IPD on a case-by-case basis, after approval by our IRB.
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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.
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 SLE - Systemic Lupus Erythematosus, run by Biomedical Research Foundation, Academy of Athens at 1 site in Greece.
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 5 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 8 Sep 2025. 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 Greece. 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 Dimitrios T. Boumpas, Professor in Medicine (00306937212025, boumpasd@uoc.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bilag A flare (time frame: From enrollment to the end of treatment (expected follow-up duration 1-4 years).). 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 NCT07056621, which also lists 6 linked publications.
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 8 Sep 2025.