Real-world use of anifrolumab for active 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 investigator-initiated, observational multicenter cohort will follow adults with active SLE who have started anifrolumab in routine practice to collect data on clinical response and adverse events. The primary focus is on clinical effectiveness and the incidence of treatment-related adverse events, with secondary analyses by clinical manifestation, patient-reported outcomes, quality of life, and steroid-sparing effects. Patients are enrolled if they meet accepted SLE classification criteria and have given informed consent, and treatment is managed by the treating physician rather than assigned by protocol. Data will be collected from participating centers (lead site University of Pisa) and analyzed to describe real-world outcomes and safety.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients diagnosed with SLE according to classification criteria valid at diagnosis time (1997, 2012, 2019)
* Written informed consent
* Active disease for which the patient is a candidate for Anifrolumab treatment (including compassionate use)
* Active disease for which the patient has started Anifrolumab treatment

Exclusion Criteria:

* Age \<18 years
* Absence of patient consent

Where it's running

• University of Pisa
  Pisa, Italy Recruiting

Study contacts

• Study coordinator: Chiara Tani, MD, PhD
• Email: chiara.tani@unipi.it
• Phone: +39050993268

Similar studies

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

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• Anifrolumab Pregnancy Study in women with lupus

  This study looks at pregnancy outcomes in women with moderate to severe SLE who took anifrolumab during pregnancy and compares them to similar women who did not take the drug.

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• Anifrolumab and risk of cancers and serious infections in SLE

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  Recruiting at 4 sites AstraZeneca · Copenhagen and 3 other locations · NCT07000110

• Monitoring pregnancy and infant outcomes after anifrolumab exposure

  This program collects health information to see if exposure to the lupus medicine anifrolumab affects pregnant people or their babies.

  Recruiting AstraZeneca · Södertälje · NCT06795893

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.