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Real-World lupus study reveals how new drug performs outside clinical trials

NCT ID NCT06626945

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at 152 adults with systemic lupus erythematosus (SLE) who started taking anifrolumab during its first year on the market in Spain. Researchers tracked their disease activity, flare-ups, and remission rates using standard medical records. The goal was to see how well the drug works in real-world settings, not just in controlled 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

152 people

The number who actually took part.

Started

Feb 2025

Finished

Jun 2025

Lead sponsor

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 will include patients diagnosed with SLE who attended the specialist's office at the participating hospitals in the study and initiated anifrolumab during the following period, between June 1st, 2023, and May 31st, 2024.

Ages

18 to 130 years

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Fulfilled the 2019 EULAR/ACR criteria for SLE at the date of anifrolumab initiation. * Aged 18 years or older at the date of anifrolumab initiation. * Have initiated anifrolumab between June 1st, 2023, and May 31st, 2024 * Have at least 12 months of medical history prior to anifrolumab initiation. Exclusion Criteria: * Current or previous exposure to anifrolumab as part of a clinical trial or Early Access Program (EAP).

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Conditions

The condition(s) this trial relates to.

systemic lupus erythematosus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Systemic lupus erythematosus (SLE)

Contacts and locations

Locations

  • Research Site

    Barcelona, Spain

  • Research Site

    Granada, Spain

  • Research Site

    Jaén, Spain

  • Research Site

    L'Hospitalet de Llobregat, Spain

  • Research Site

    León, Spain

  • Research Site

    Madrid, Spain

  • Research Site

    Málaga, Spain

  • Research Site

    Mérida, Spain

  • Research Site

    Móstoles, Spain

  • Research Site

    Murcia, Spain

  • Research Site

    Seville, Spain

  • Research Site

    Toledo, Spain

  • Research Site

    Valladolid, Spain

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