Lupus drug anifrolumab put to the test in everyday patients
NCT ID NCT07215754
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study follows 300 people with active systemic lupus erythematosus (SLE) who are taking anifrolumab, a drug that blocks a key immune signal. Researchers will track how many achieve remission or low disease activity over 5 years, as well as side effects and quality of life. The goal is to see if the drug works as well in real-world clinics as it did in earlier trials.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- anifrolumab
- What this could lead to
- If successful, this study could confirm that anifrolumab helps more lupus patients achieve remission or low disease activity with fewer steroids in everyday practice.
- What could go wrong
- This is an observational study, not a controlled trial, so results may be less reliable. It is also early-stage real-world evidence, and the drug may not work as well outside clinical trials.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2023
- Expected to finish
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May 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
All patients with SLE starting treatment with Anifrolumab according to the AIFA indications will be enrolled.
- Ages
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18 years and older
- Sex
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Anyone
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Pisa
RECRUITINGPisa, 56100, Italy
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