RECRUITINGOBSERVATIONAL
Achievement of LLDAS5 in Patients With Systemic Lupus Erythematosus Treated With Anifrolumab.
DAHLIA: Achievement of Low Level of Disease Activity With a Dose of Corticosteroids Less Than or Equal to 5 mg (LLDAS5): a Real-life Study With Anifrolumab on Patients With Systemic Lupus Erythematosus in Italy
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
Who May Be Eligible (Plain English)
Who May Qualify:
- Provided willing to sign a consent form 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;
Who Should NOT Join This Trial:
- 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 willing to sign a consent form and to fill in patient questionnaires
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
BIOLOGICAL
Anifrolumab
anifrolumab - fully human monoclonal antibody target type I INF
Locations (19)
Azienda Ospedaliero-Universitaria di Cagliari Presidio di Monserrato
Monserrato, CA, Italy
Azienda Ospedaliero-Universitaria di Ferrara Arcispedale Sant'Anna
Cona, Ferrara, Italy
IRCCS Humanitas Research Hospital
Rozzano, Milano, Italy
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
Policlinico di Modena - AOU di Modena
Modena, 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