EICHORCondition: Systemic Lupus Erythematosus · Sponsor: University of Pisa
Interested? Contact the study team ↓
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 life and other patient-reported outcome measures (PROMs); - to evaluate the steroid-sparing potential of therapy; - to assess the speed of therapeutic action on different clinical manifestations; - to identify predictive variables of clinical response to therapy; - to evaluate drug retention rate; - to assess the efficacy of therapy in reducing organ damage accumulation. PRIMARY AND SECONDARY ENDPOINTS. Primary efficacy endpoints: - Percentage of patients in remission (DORIS criteria) at 6, 12, 24, 36, 48, and 60 months; - Percentage of patients in low disease activity state (LLDAS) at 6, 12, 2…
This description comes directly from the study's public registry record.
Chiara Tani, MD, PhD · +39050993268 · chiara.tani@unipi.it
There is no obligation to join — the study team can answer your questions about taking part.
Always discuss trial participation with your own doctor first.
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
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| University of Pisa | Pisa, Italy | Recruiting |
This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.
Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.
We email about this public record only. Unsubscribe anytime with one click. Never medical advice. By subscribing you agree to our Terms of Use and Privacy Policy.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT07215754