Disease activity and quality of life in adults with SLE starting subcutaneous anifrolumab
Effectiveness of Subcutaneous Anifrolumab in Systemic Lupus Erythematodes - A Non-interventional, Prospective, Multicenter Study on Disease Activity in SLE Patients Treated With Subcutaneous Anifrolumab in Routine Care
This project will try to see how subcutaneous anifrolumab works for adults with lupus by collecting clinical measurements and patient-reported outcomes in routine care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 125 (estimated) |
| Ages | 18 Years to 130 Years |
| Sex | All |
| Sponsor | AstraZeneca Industry-sponsored |
| Drugs / interventions | anifrolumab, cyclophosphamide |
| Locations | 16 sites (Altenburg and 15 other locations) |
| Trial ID | NCT07424261 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18 years) with a diagnosis of SLE who are about to start subcutaneous anifrolumab for the first time, can give informed consent, and are not receiving concurrent biologic therapies are ideal candidates.
Not a fit: Patients with prior anifrolumab exposure, current treatment with other biologics, or active severe lupus nephritis or unstable neuropsychiatric lupus are excluded and likely not to benefit from participating.
Why it matters
Potential benefit: If successful, the study could give patients and clinicians clearer real-world information on remission rates, flare frequency, medication changes, and quality-of-life improvements with subcutaneous anifrolumab.
How similar studies have performed: Intravenous anifrolumab showed benefit in randomized trials and emerging real-world studies support its effectiveness, while real-world data specifically for the subcutaneous formulation are more limited and still emerging.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Altenburg and 15 other locations
- Research Site — Altenburg, Germany (Recruiting)
- Research Site — Bad Bramstedt, Germany (Recruiting)
- Research Site — Berlin, Germany (Recruiting)
- Research Site — Chemnitz, Germany (Recruiting)
- Research Site — Erlangen, Germany (Recruiting)
- Research Site — Heidelberg, Germany (Recruiting)
- Research Site — Herne, Germany (Recruiting)
- Research Site — Kassel, Germany (Recruiting)
- Research Site — Leipzig, Germany (Recruiting)
- Research Site — Meerbusch-Lank, Germany (Recruiting)
- Research Site — München, Germany (Recruiting)
- Research Site — Planegg, Germany (Recruiting)
- Research Site — Schwerin, Germany (Recruiting)
- Research Site — Trier, Germany (Recruiting)
- Research Site — Wetzlar, Germany (Recruiting)
- Research Site — Wuppertal, Germany (Recruiting)
Study contacts
- Study coordinator: AstraZeneca Clinical Study Information Center
- Email: information.center@astrazeneca.com
- Phone: 1-877-240-9479
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.