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

NCT07330245

RecruitingN/A

Sponsor: AstraZeneca

Conditions: Lupus Erythematosus, Systemic

Interventions: Anifrolumab

Countries: Italy

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 overview

Sex: ALL

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
Inclusion Criteria:

* 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;

Exclusion Criteria:

* 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;
* Inability to understand and sign the informed consent and to fill in patient questionnaires
Locations (22)
  • Monserrato, CA, Italy
  • Cona, Ferrara, Italy
  • San Giovanni Rotondo, Foggia, Italy
  • Rozzano, Milano, Italy
  • Ancona, Italy
  • Bari, Italy
  • Brescia, Italy
  • Florence, Italy
  • Milan, Italy
  • Milan, Italy
  • Modena, Italy
  • Naples, Italy
  • Padova, Italy
  • Palermo, Italy
  • Pavia, Italy
  • Pisa, Italy
  • Roma, Italy
  • Roma, Italy
  • Torino, Italy
  • Trieste, Italy
  • Udine, Italy
  • Verona, Italy