Anifrolumab to achieve LLDAS5 in people with systemic lupus erythematosus

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter observational study in Italy following adults with SLE who are starting anifrolumab per the approved label. The study will record whether patients achieve and maintain Lupus Low Disease Activity State with prednisone (or equivalent) ≤5 mg/day (LLDAS5) and will capture corticosteroid tapering strategies used in routine care. Investigators will also record DORIS remission status and changes in depressive symptoms over the study period. Patients already in LLDAS5, with prior anifrolumab exposure, or with certain severe active organ manifestations are excluded.

Why it matters

Who can join: the full rules

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's running

• Azienda Ospedaliero-Universitaria di Cagliari Presidio di Monserrato
  Monserrato, Ca, Italy Recruiting
• Azienda Ospedaliero-Universitaria di Ferrara Arcispedale Sant'Anna
  Cona, Ferrara, Italy Recruiting
• IRCCS Casa Sollievo della Sofferenza
  San Giovanni Rotondo, Foggia, Italy Recruiting
• IRCCS Humanitas Research Hospital
  Rozzano, Milano, Italy Recruiting
• AOU Ospedali Riuniti di Ancona - Presidio Torrette
  Ancona, Italy Recruiting
• ASST Spedali Civili di Brescia
  Brescia, Italy Recruiting

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.