NCT07056621 Does Belimumab Modify the Natural History of SLE? A Propensity Score-matched, Real-world Study
| NCT ID | NCT07056621 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Biomedical Research Foundation, Academy of Athens |
| Condition | SLE - Systemic Lupus Erythematosus |
| Study Type | OBSERVATIONAL |
| Enrollment | 684 participants |
| Start Date | 2025-06-30 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 684 participants in total. It began in 2025-06-30 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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: 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.
Eligibility 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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07056621 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying SLE - Systemic Lupus Erythematosus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07056621 currently recruiting?
Yes, NCT07056621 is actively recruiting participants. Contact the research team at boumpasd@uoc.gr for enrollment information.
Where is the NCT07056621 trial being conducted?
This trial is being conducted at Athens, Greece.
Who is sponsoring the NCT07056621 clinical trial?
NCT07056621 is sponsored by Biomedical Research Foundation, Academy of Athens. The trial plans to enroll 684 participants.
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