A Treatment Effectiveness Study Among SLE Patients Receiving Anifrolumab in Routine Clinical Practice.

NCT05637112 · tracked via the Priya Life Science Germany tracker

Sponsor

AstraZeneca

Phase

Observational

Started

2023-02-27

Last updated

2026-09-24

Condition(s) studied

Systemic Lupus Erythematosus

Investigational drug(s) / intervention(s)

None (Observational study)

None (Observational study): Not Applicable since Observational Study

Study summary

Anifrolumab Study of Treatment Effectiveness in the Real World (ASTER) study will collect real world data to obtain a good understanding of the (sustained) clinical effect and patient quality of life outcomes among diagnosed SLE patients who initiate anifrolumab treatment. ASTER will generate critical real-world evidence on the benefits of adding anifrolumab to standard of care treatment for SLE in routine clinical practice, to inform physicians, payers and patients.

Eligibility

Sex

ALL

Min age

18 Years

Max age

130 Years

Healthy volunteers

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.

Primary outcome measure(s)

Disease activity assessed by the Physician Global Assessment (PGA) — From Baseline (1 year pre-anifrolumab) until follow-up 5 years post-anifrolumab initiation
The PGA is a single-item visual analogue scale that describes the physician assessment of a patient's disease and its impact on daily functioning at the time of assessment. The scale ranges from 0 (asymptomatic disease and no limitation of normal activities) to 3 (severe disease and limitation of normal activities).
Disease activity assessed by Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) — From Baseline (1 year pre-anifrolumab) until follow-up 5 years post-anifrolumab initiation
The SLEDAI-2K is a global index and includes 24 clinical symptoms and laboratory variables that are weighted by the type of manifestation, but not by severity or dynamic of the individual item. The SLEDAI-2K includes scoring for antibodies and low complement, as well as some renal and hematologic parameters. The total score ranges between 0 and 105, with higher scores representing increased disease activity.
Proportion of patients attaining the composite endpoint of lupus low disease activity (LLDAS) — From Baseline (1 year pre-anifrolumab) until follow-up 5 years post-anifrolumab initiation
The proportion of patients attaining the composite endpoint of LLDAS will be assesed.

Trial sites (74)

Facility	City	Region
Research Site	Innsbruck	Tyrol
Research Site	Linz	Upper Austria
Research Site	Vienna	Austria
Research Site	Liège	Li Ge
Research Site	Leuven	Belgium
Research Site	Calgary	Alberta
Research Site	Winnipeg	Manitoba
Research Site	Hamilton	Ontario
Research Site	Orillia	Ontario
Research Site	Toronto	Ontario
Research Site	Rimouski	Quebec
Research Site	Sherbrooke	Quebec
Research Site	Ste-Foy	Quebec
Research Site	Nice	Alpes-Maritimes
Research Site	Clermont-Ferrand	Auvergne-Rh ne-Alpes
Research Site	Strasbourg	Bas-Rhin
Research Site	Finist Re	Brest Cedex
Research Site	Dijon	C te-d'Or
Research Site	Bordeaux	Gironde
Research Site	Grenoble	Is Re
Research Site	Saint-Denis	La R Union
Research Site	Nantes	Loire-Atlantique
Research Site	Bouches-du-Rh Ne	Lyon
Research Site	FORT de France Cedex	Martinique
Research Site	Lille	Nord
Research Site	Seine-Maritime	Rouen
Research Site	Paris	France
Research Site	Paris	France
Research Site	Paris	France
Research Site	Paris	France
Research Site	Paris	France
Research Site	Heidelberg	Baden-W Rttemberg
Research Site	Heidelberg	Baden-Wurttemberg
Research Site	Erlangen	Bavaria
Research Site	Bad Bramstedt	Free and Hanseatic City of Hamburg
Research Site	Schleswig-Holstein	L Beck
Research Site	Greifswald	Mecklenburg-Vorpommern
Research Site	Cologne	North Rhine-Westphalia
Research Site	D Sseldorf	North Rhine-Westphalia
Research Site	Herne	North Rhine-Westphalia

+ 34 more sites — see the full list on the official registry below.

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Other trials for the same condition

Phase 3 Study to Evaluate Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 2) Active, not recruiting

A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE) Active, not recruiting

Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension). Recruiting

A First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7507062 in Participants With Systemic Lupus Erythematosus Active, not recruiting

An Open-label, Study to Assess Safety, Efficacy and Cellular Kinetics of YTB323 in Severe, Refractory Systemic Lupus Erythematosus Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05637112 on ClinicalTrials.gov ↗ ← All trials in Germany