Disease activity and quality of life in adults with SLE starting subcutaneous anifrolumab

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, single-arm, multicenter observational study follows adults with systemic lupus erythematosus who are initiating subcutaneous anifrolumab for the first time according to the European SmPC. Patients will be followed for 24 months in routine clinical practice with scheduled visits to capture clinical disease activity, DORIS remission and LLDAS, patient-reported quality of life and fatigue, concomitant medication use, flares, and organ damage. The study does not dictate treatment and only includes patients whose prescribers independently chose anifrolumab SC; prior exposure to anifrolumab or concurrent biologics are exclusion criteria. Data will be collected at participating centers in real-world settings to describe long-term disease control and treatment patterns.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥18 years at the time of signing the informed consent
* Diagnosis of SLE
* Prescription of anifrolumab SC in line with the european summary of product characteristics (SmPC)
* Prescription of anifrolumab SC was decided prior to and independently of the study
* Signed and dated written informed consent prior to enrolment into the study
* Willing and able to participate in all study evaluations and procedures

Exclusion Criteria:

* Prior exposure to anifrolumab
* Treatment with concurrent biologics
* Current or planned participation in a clinical study that does not constitute routine care
* Currently experiencing a severe or rapidly progressive Class III or IV glomerulonephritis requiring induction therapy (mycophenolate mofetil \[MMF\]/cyclophosphamide + high dose steroids), isolated Class V lupus nephritis (in absence of other SLE manifestations, i.e. skin/joint involvement), or active severe or unstable neuropsychiatric lupus
* Conditions (acute or chronic) or events at the time of signing the informed consent that would limit the patient's ability to complete questionnaires or participate in this study over the period of 24 months according to the treating physician (e.g., clinically significant cognitive impairment or dementia, unstable severe psychiatric illness, uncontrolled alcohol or substance use disorder that interferes with adherence to care or other circumstances that preclude completing PROs or attending routine visits)
* Pregnancy or breast feeding at study enrolment

Where it's running

• Research Site
  Altenburg, Germany Recruiting
• Research Site
  Bad Bramstedt, Germany Recruiting
• Research Site
  Bamberg, Germany Recruiting
• Research Site
  Berlin, Germany Recruiting
• Research Site
  Braunschweig, Germany Recruiting
• Research Site
  Chemnitz, Germany Recruiting

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Anifrolumab in Chinese patients with active moderate-to-severe SLE

  This study tests whether adding anifrolumab to standard care helps Chinese adults with active moderate-to-severe SLE achieve remission and reduces glucocorticoid use.

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• Anifrolumab to achieve LLDAS5 in people with systemic lupus erythematosus

  This study tests whether anifrolumab helps people with systemic lupus erythematosus reach and keep low disease activity while staying on 5 mg/day or less of corticosteroids.

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• Effects of anifrolumab on arterial inflammation in SLE patients

  This study tests whether anifrolumab can reduce blood vessel inflammation in people with active systemic lupus erythematosus.

  Recruiting University of Cambridge · Cambridge, Cambridgeshire · NCT07913919

• Pain patterns in rheumatic diseases: see if pain works differently in patients and healthy people

  This observational study tests how pain is experienced and measured in people with rheumatic diseases compared with healthy volunteers.

  Recruiting National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT07829497

• Keeping you on anifrolumab after a positive finish with your prior study

  This study lets people who finished a prior anifrolumab trial and still benefit continue receiving the medicine to see if it stays safe and tolerable for them.

  Recruiting at 4 sites Phase 3 AstraZeneca · Phoenix, Arizona and 165 other locations · NCT07691970

• Subcutaneous anifrolumab in children with systemic lupus erythematosus

  This study tests whether subcutaneous anifrolumab is safe and how it behaves in the body for kids with moderate to severe SLE already on standard care.

  Recruiting at 2 sites Phase 2 AstraZeneca · Nedlands and 38 other locations · NCT07630714

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.