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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.
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