Does Belimumab Modify the Natural History of SLE? A Propensity Score-matched, Real-world Study
Recruiting
Observational Study
SLE - Systemic Lupus Erythematosus
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Observational
- Participants needed
- 684 (estimated)
- Sponsor
- Biomedical Research Foundation, Academy of Athens · Other
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About This Trial
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…
Trial Locations
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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 As…
Contacts