Achievement of LLDAS5 in Patients With Systemic Lupus Erythematosus Treated With Anifrolumab.
Recruiting · NCT07330245 · Observational (researchers observe without assigning treatment) · Lead sponsor: AstraZeneca
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Who can take part
Age range
No age limits stated
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
22 locations listed.
- AOU Ospedali Riuniti di Ancona - Presidio Torrette - Ancona, Italy
- Azienda Ospedaliero-Universitaria Policlinico di Bari - Bari, Italy
- ASST Spedali Civili di Brescia - Brescia, Italy
- Azienda Ospedaliero-Universitaria Careggi - Florence, Italy
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Milan, Italy
- IRCCS Ospedale San Raffaele - Milan, Italy
- Policlinico di Modena - AOU di Modena - Modena, Italy
- Azienda Ospedaliera Universitaria "Luigi Vanvitelli" - Naples, Italy
- Azienda Ospedaliera di Padova - Padova, Italy
- Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone" - Palermo, Italy
- Fondazione IRCCS Policlinico San Matteo - Pavia, Italy
- Azienda Ospedaliero-Universitaria Pisana Ospedale Santa Chiara - Pisa, Italy
- Policlinico Tor Vergata - Roma, Italy
- Policlinico Umberto I - Sapienza Università di Roma - Roma, Italy
- Azienda Ospedaliera Ordine Mauriziano Umberto I - Torino, Italy
- Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI) - Ospedale di Cattinara - Trieste, Italy
- ASU Friuli Centrale - Ospedale Santa Maria della Misericordia di Udine - Udine, Italy
- AOUI Verona - Ospedale Borgo Roma - Verona, Italy
- Azienda Ospedaliero-Universitaria di Cagliari Presidio di Monserrato - Monserrato, CA, Italy
- Azienda Ospedaliero-Universitaria di Ferrara Arcispedale Sant'Anna - Cona, Ferrara, Italy
- IRCCS Casa Sollievo della Sofferenza - San Giovanni Rotondo, Foggia, Italy
- IRCCS Humanitas Research Hospital - Rozzano, Milano, Italy