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Lupus drug anifrolumab put to the test in Real-World study

NCT ID NCT05637112

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 04, 2026 · Updated 1 time

Summary

This study follows 551 people with lupus who are starting anifrolumab for the first time. Researchers will track how well the drug controls disease activity, reduces flares, and improves quality of life over time. The goal is to see if the benefits seen in clinical trials hold up in routine medical practice.

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

551 people

The number who actually took part.

Started

Feb 2023

Expected to finish

Dec 2030

An estimate. End dates often move.

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

All patients aged ≥18 years diagnosed with SLE who initiate anifrolumab as prescribed by their healthcare provider (HCP) per the approved country-specific label and are treated at the study sites will be eligible for inclusion.

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 (European League Against Rheumatism)/ACR (American College of Rheumatology) criteria for SLE at the time of study entry. * Prescribed anifrolumab for their SLE treatment for the first time, according to approved country-specific label. * The Physician's decision to prescribe anifrolumab must occur prior to any study-related discussion. * In countries where prescription reimbursements are authorised on a case-by-case basis, authorisation (ie, patient access to treatment) will be required for study entry. Exclusion Criteria: * Currently participating in an anifrolumab early access/compassionate use program or an interventional clinical trial with an investigational product. * Any previous exposure to anifrolumab (including as part of a clinical trial or early access programme). * Documented diagnosis of severe or rapidly progressive Class III or IV glomerulonephritis requiring induction therapy (mycophenolate mofetil \[MMF\]/cyclophosphamide \[CYC\] + high dose steroids), isolated Class V lupus nephritis (in absence of other SLE manifestations, ie. skin/joint involvement), or active severe or unstable neuropsychiatric lupus. * Any other condition which the investigator deems to limit a patient's ability to understand the informed consent.

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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

Contacts and locations

Locations

  • Research Site

    Innsbruck, Tyrol, 6020, Austria

  • Research Site

    Linz, Upper Austria, 4020, Austria

  • Research Site

    Vienna, 1180, Austria

  • Research Site

    Liège, Li Ge, 4000, Belgium

  • Research Site

    Leuven, 3000, Belgium

  • Research Site

    Calgary, Alberta, T2N 4N1, Canada

  • Research Site

    Winnipeg, Manitoba, RR149, Canada

  • Research Site

    Hamilton, Ontario, L8N 3Z5, Canada

  • Research Site

    Orillia, Ontario, L3V 1T5, Canada

  • Research Site

    Toronto, Ontario, M5T 2S9, Canada

  • Research Site

    Rimouski, Quebec, G5L 5T1, Canada

  • Research Site

    Sherbrooke, Quebec, J1G 2E8, Canada

  • Research Site

    Ste-Foy, Quebec, G1V 4G2, Canada

  • Research Site

    Nice, Alpes-Maritimes, 6000, France

  • Research Site

    Clermont-Ferrand, Auvergne-Rh ne-Alpes, 63000, France

  • Research Site

    Strasbourg, Bas-Rhin, 67098, France

  • Research Site

    Finist Re, Brest Cedex, 29609, France

  • Research Site

    Dijon, C te-d'Or, 21079, France

  • Research Site

    Bordeaux, Gironde, 33076, France

  • Research Site

    Grenoble, Is Re, 38043, France

  • Research Site

    Saint-Denis, La R Union, 97405, France

  • Research Site

    Nantes, Loire-Atlantique, 44093, France

  • Research Site

    Bouches-du-Rh Ne, Lyon, 69003, France

  • Research Site

    FORT de France Cedex, Martinique, 97261, France

  • Research Site

    Lille, Nord, 59037, France

  • Research Site

    Seine-Maritime, Rouen, 76230, France

  • Research Site

    Paris, 14033, France

  • Research Site

    Paris, 75013, France

  • Research Site

    Paris, 75014, France

  • Research Site

    Paris, 75020, France

  • Research Site

    Paris, 75475, France

  • Research Site

    Heidelberg, Baden-W Rttemberg, 69120, Germany

  • Research Site

    Heidelberg, Baden-Wurttemberg, 69120, Germany

  • Research Site

    Erlangen, Bavaria, 91054, Germany

  • Research Site

    Bad Bramstedt, Free and Hanseatic City of Hamburg, 24576, Germany

  • Research Site

    Schleswig-Holstein, L Beck, 23562, Germany

  • Research Site

    Greifswald, Mecklenburg-Vorpommern, 17493, Germany

  • Research Site

    Cologne, North Rhine-Westphalia, 51149, Germany

  • Research Site

    D Sseldorf, North Rhine-Westphalia, 40225, Germany

  • Research Site

    Herne, North Rhine-Westphalia, 44649, Germany

  • Research Site

    Mainz A. Rhein, Rhineland-Palatinate, 55131, Germany

  • Research Site

    Magdeburg, Saxony-Anhalt, 39104, Germany

  • Research Site

    Greifwald, Vorpommern-Greifswald, 17489, Germany

  • Research Site

    Berlin, 10117, Germany

  • Research Site

    Kfar Saba, Central District, 4428164, Israel

  • Research Site

    Tel Hashomer, Central District, 5211401, Israel

  • Research Site

    Tiberias, Galilee, 15208, Israel

  • Research Site

    Haifa, Haifa District, 3109601, Israel

  • Research Site

    Haifa, Haifa District, 3436212, Israel

  • Research Site

    Jerusalem, Jerusalem, 91120, Israel

  • Research Site

    Afula, Northern District, 18101, Israel

  • Research Site

    Ramat Gan, Tel Aviv, 52621, Israel

  • Research Site

    Tel Aviv, Tel Aviv, 6423906, Israel

  • Research Site

    Naples, Campania, 80131, Italy

  • Research Site

    Cona, Emilia-Romagna, 44124, Italy

  • Research Site

    Udine, Friuli Venezia Giulia, 33100, Italy

  • Research Site

    Rome, Lazio, 149, Italy

  • Research Site

    Brescia, Lombardy, 25100, Italy

  • Research Site

    Milan, Lombardy, 20122, Italy

  • Research Site

    Turin, Piedmont, 10126, Italy

  • Research Site

    Cagliari, Sardinia, 9042, Italy

  • Research Site

    Ancona, 60126, Italy

  • Research Site

    Bari, 70124, Italy

  • Research Site

    Florence, 50134, Italy

  • Research Site

    Milan, 20122, Italy

  • Research Site

    Milan, 20132, Italy

  • Research Site

    Pisa, 56126, Italy

  • Research Site

    Roma, 161, Italy

  • Research Site

    Roma, 168, Italy

  • Research Site

    Örebro, N Rke, 70185, Sweden

  • Research Site

    Stockholm, Uppland, 171 76, Sweden

  • Research Site

    Dubai, Dubayy, 7272, United Arab Emirates

  • Research Site

    Sharjah city, Emirate of Sharjah, 72772, United Arab Emirates

  • Research Site

    Abu Dhabi, United Arab Emirates

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