Lupus drug saphnelo under Real-World watch in women
NCT ID NCT07431775
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study will look at how the lupus medication Saphnelo (anifrolumab) is being used in women aged 15 to 50 who could become pregnant. Researchers will track how many women use the drug each year and describe their health characteristics. The goal is to gather real-world information to better understand safety in pregnancy, as required by health authorities.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Anifrolumab (Saphnelo)
- What this could lead to
- If successful, this study will provide real-world data on how Saphnelo is used in women who could become pregnant, helping to guide safer use and inform pregnancy-related safety.
- What could go wrong
- This is an observational study, not a treatment trial, so it won't test if Saphnelo works or is safe. Results depend on the quality of existing medical records and may not apply to all patients.
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 26,000,000 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2032
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The study population for the primary objectives will be all female patients of reproductive potential (defined as females aged 15 to 50 years old) observed during the patient identification period. The study population for the secondary objectives will be female patients of reproductive potential who newly initiated anifrolumab use during the patient identification period. Secondary Objective 3 is restricted to a subset of the broader secondary objective population, and includes female patients of reproductive potential who initiate anifrolumab use and have a prior record of SLE diagnosis. Study populations will be identified separately within each country-specific secondary healthcare data source from Denmark, France, Germany, and the US.
- Ages
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15 to 50 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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.
Patients will be included in the primary objective cohort for a given calendar year interval, if they satisfy the following inclusion and exclusion criteria within that year: Inclusion Criteria: * Observability (enrollment or activity) in the data source for at least one day during the patient identification period within that calendar year (set earliest qualifying date as "index date" for primary objectives) * Female sex at index date * Age ≥15 and ≤50 years at index date Exclusion Criteria: * (Primary Objective 1a only) Evidence of prior anifrolumab use in all available data prior to the index date through 1 day prior to the index date Patients will be included in the secondary objective cohort if they satisfy the following inclusion and exclusion criteria: Inclusion criteria * Receipt of anifrolumab therapy during the patient identification period (identify earliest record of anifrolumab in this period and set as "index date" for secondary objectives). * Female sex at index date. * Age ≥15 and ≤50 years at index date. * ≥180 days of continuous observability (e.g., enrollment or activity) in the dataset prior to and including the index date. * (For Secondary Objective 3 only) SLE diagnosis, defined as having at least one unique health care encounter record with an International Classification of Diseases, 10th Revision (ICD-10) code of M32\* (excluding M32.0: drug-induced SLE) within the 180-day baseline period prior to and including the index date. Exclusion criteria * Evidence of prior anifrolumab use in all available data prior the index date through 1 day prior to the index date.
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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 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.
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