Belimumab and the long-term course of lupus
Official title: Does Belimumab Modify the Natural History of SLE? A Propensity Score-matched, Real-world Study
Run by Biomedical Research Foundation, Academy of Athens · NCT07056621 · Data updated 2026-11-12
This study will see if belimumab lowers the risk of new major organ flares in adults with active systemic lupus compared with standard care.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 684 (estimated) |
| Sponsor | Biomedical Research Foundation, Academy of Athens Academic / other |
| Drugs / interventions | belimumab |
| Locations | 1 site (Athens, Attica) |
| Status | Recruiting |
| Started | June 30, 2025 |
| Main results expected | June 2026 |
| Study ends | June 2026 |
| Registry record updated | September 8, 2025 |
| Trial ID | NCT07056621 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with SLE by SLICC criteria who have active disease (SLEDAI-2K ≥4 and PGA >1), at least six months of follow-up, and complete medical records are ideal candidates.
✕Probably not a fit
Patients with mild or inactive disease, concomitant autoimmune disorders (other than thyroid disease), incomplete records, or those under 18 are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This combined retrospective and prospective cohort study will compare patients treated with belimumab to two standard-of-care cohorts (a contemporary cohort and a historical pre-2014 cohort). The primary outcome is the incidence of de novo major organ manifestations defined by BILAG A flares, analyzed using time-to-event methods such as Kaplan–Meier curves and Cox regression. Investigators will use propensity score matching and inverse probability weighting to balance baseline differences between treatment groups and reduce confounding. Longitudinal mixed-effects models will also be used to analyze repeated measures of disease activity over follow-up.
Why it matters
Potential benefit: If successful, belimumab could reduce the occurrence of new major organ involvement in SLE, lowering risk of severe complications and long-term damage.
How similar studies have gone: Post-hoc analyses of BLISS trials suggested reduced de novo renal flares with belimumab at certain doses, but real-world evidence is limited and effects on neuropsychiatric and other severe organ events remain unclear.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Patients with incomplete medical records or missing key variables * Patients with concomitant autoimmune disorders (excluding thyroid disease)
Where it's running
-
University Hospital 'Attikon'
Athens, Attica, Greece Recruiting
Study contacts
- Study coordinator: Dimitrios T. Boumpas, Professor in Medicine
- Email: boumpasd@uoc.gr
- Phone: 00306937212025
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.