Achievement of LLDAS5 in Patients With Systemic Lupus Erythematosus Treated With Anifrolumab.

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorAstraZeneca

About this trial

This is an observational, multicenter, prospective study on patients with systemic lupus erythematosus treated with anifrolumab in Italy aimed at evaluating the achievement of LLDAS5

Eligibility criteria

Qualifiers

Provided informed consent to participate in the study;

Aged 18 years or older;

Fulfilled the 2019 EULAR/ACR classification criteria for SLE at the time of study entry;

Prescribed anifrolumab for SLE treatment for the first time, according to the approved Italian label and reimbursement criteria;

Disqualifiers

Patients who are at LLDAS5 at the time of study entry;

Previous exposure to anifrolumab;

Documented diagnosis of severe or rapidly progressive Class III or IV glomerulonephritis requiring induction therapy [mycophenolate mofetil (MMF)/cyclophosphamide (CYC) + high dose steroids], isolated Class V lupus nephritis, or active severe or unstable neuropsychiatric lupus

Currently participating in any interventional clinical trial with an investigational product;

Trial design

Treatments tested in this trial

  • Anifrolumab

Treatment groups

No treatment groups listed

Locations

22
Azienda Ospedaliero-Universitaria di Cagliari Presidio di Monserrato09032, MonserratoCA, Italy
Azienda Ospedaliero-Universitaria di Ferrara Arcispedale Sant'Anna44124, ConaFerrara, Italy
IRCCS Casa Sollievo della Sofferenza San Giovanni RotondoFoggia, Italy
IRCCS Humanitas Research Hospital20089, RozzanoMilano, Italy

Sponsors and collaborators

AstraZeneca

Lead sponsor