Real-world use of anifrolumab for active systemic lupus erythematosus
Real World Evidence of Anifrolumab in Systemic Lupus Erythematosus: a Multicenter Spontaneous Observational Study Aimed at Evaluating the Efficacy and Safety of Anifrolumab in a Cohort of Patients With Active Systemic Lupus Erythematosus
This project will see if anifrolumab helps adults with active systemic lupus erythematosus when given in routine clinical care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pisa Academic / other |
| Drugs / interventions | Anifrolumab, prednisone |
| Locations | 1 site (Pisa) |
| Trial ID | NCT07215754 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (18 years or older) with a documented diagnosis of SLE by accepted classification criteria who have active disease and are starting or are candidates for anifrolumab and can provide informed consent are ideal participants.
Not a fit: Patients under 18, those without active disease or not receiving anifrolumab, and individuals unable to give informed consent are not expected to benefit from participation.
Why it matters
Potential benefit: If successful, the results could clarify how well anifrolumab works and how safe it is in everyday clinical practice and help identify which patients benefit most.
How similar studies have performed: Randomized phase II and III trials have shown anifrolumab can be effective and generally safe in moderate-to-severe SLE, while large real-world observational data remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Pisa
- University of Pisa — Pisa, Italy (Recruiting)
Study contacts
- Study coordinator: Chiara Tani, MD, PhD
- Email: chiara.tani@unipi.it
- Phone: +39050993268
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.