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Real World Evidence of Anifrolumab in Systemic Lupus Erythematosus: Investigator Initiated, Observational, Multicenter Study Evaluating Effectiveness and Safety of Anifrolumab in Active SLE Patients

Recruitingn/aAges 18 Years - anyAllUniversity of Pisa
NCT07215754 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

BACKGROUND AND RATIONALE. The role of type I interferons (IFN) in innate and adaptive immunity has been extensively studied, establishing a key role for type I IFNs in immune homeostasis. With growing evidence that type I IFNs play an important role in autoimmune diseases, inhibition of type I IFN biological activity with Anifrolumab represents a significant therapeutic option in SLE. Phase II and III clinical trials have demonstrated the efficacy and safety of the drug in patients with moderate-to-severe active disease. OBJECTIVES. The primary objective of the study is to evaluate the clinical efficacy and incidence of adverse events associated with Anifrolumab therapy in a multicenter cohort of patients with SLE. Secondary objectives of the study are: - to evaluate the efficacy of therapy on different types of clinical manifestations; - to assess the impact of therapy on quality of li

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📋 Eligibility rules (as published)
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
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What it tests

  • Not listed
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Where

1 site
University of Pisa
Pisa, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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