Observational outcomes of anifrolumab in lupus patients
Anifrolumab Real-world Treatment Outcomes in Polish Patients With Systemic Lupus Erythematosus (SLE). Multicenter, Non-interventional Study
This study is looking at how well the medication anifrolumab works for people with lupus over two years while they receive regular care in Poland.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AstraZeneca Industry-sponsored |
| Drugs / interventions | anifrolumab |
| Locations | 11 sites (Bydgoszcz and 10 other locations) |
| Trial ID | NCT06673043 on ClinicalTrials.gov |
What this trial studies
This multicenter observational study aims to gather data on patients with systemic lupus erythematosus (SLE) who are treated with anifrolumab in routine clinical practice across various sites in Poland. The study will collect longitudinal data over a period of up to 30 months, including approximately 6 months of baseline data followed by 24 months of follow-up. The goal is to assess the clinical outcomes and management of SLE patients receiving this treatment as part of the National Drug Program.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with systemic lupus erythematosus who have received anifrolumab treatment.
Not a fit: Patients who have previously participated in an anifrolumab clinical trial or those with cognitive incapacity or language barriers may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the real-world effectiveness of anifrolumab for patients with systemic lupus erythematosus.
How similar studies have performed: While this study is observational and focuses on real-world outcomes, similar studies have shown promise in evaluating treatment effectiveness in chronic conditions like lupus.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Adult (aged ≥18 years old) patients with SLE who received anifrolumab treatment in the frames of NDP in Poland. 2. Patients willing to participate in the study and signed Informed Consent Form (ICF). Exclusion Criteria: 1. Those who participated in anifrolumab clinical trial in the past, and/or those who participated/plans to participate in clinical trial on/after the date of first anifrolumab infusion through NDP. 2. Cognitive incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
Where this trial is running
Bydgoszcz and 10 other locations
- Research Site — Bydgoszcz, Poland (Recruiting)
- Research Site — Bytom, Poland (Recruiting)
- Research Site — Gdansk, Poland (Recruiting)
- Research Site — Katowice, Poland (Recruiting)
- Research Site — Krakow, Poland (Recruiting)
- Research Site — Lodz, Poland (Recruiting)
- Research Site — Lublin, Poland (Recruiting)
- Research Site — Poznan, Poland (Recruiting)
- Research Site — Rzeszów, Poland (Recruiting)
- Research Site — Warsaw, Poland (Recruiting)
- Research Site — Wroclaw, Poland (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.