Evaluating lupus outcomes after using Anifrolumab in real-world settings

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

The INTERSTELLAR study aims to gather real-world evidence on the effectiveness of Anifrolumab when added to standard care for patients with Systemic Lupus Erythematosus (SLE). This multi-country, observational cohort study will collect clinical assessments and patient-reported outcomes over a one-year follow-up period after the initial prescription of Anifrolumab. The study will include a retrospective baseline data collection and will standardize measures across participating countries to facilitate comprehensive analysis. It seeks to inform healthcare providers and patients about the potential benefits of Anifrolumab in treating SLE, particularly its impact on skin manifestations.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Aged 18 years or older at study enrolment.
2. Fulfilled the 2019 EULAR/ACR criteria1 for SLE at the time of study entry.
3. Prescribed anifrolumab for their SLE treatment for the first time, according to approved country-specific label.
4. It is important to note that a physician decision to prescribe anifrolumab will need to occur prior to any study-related discussion.
5. In countries where prescription reimbursements are authorized on a case-by-case basis, authorization (ie, patient access to treatment) will be required for study entry.
6. Provided informed consent to participate in the study.
7. Willing and able to participate in all required study evaluations and procedures.

Exclusion Criteria:

1. Currently participating in an anifrolumab early access/compassionate use program or an interventional clinical trial with an investigational product.
2. Previous exposure to anifrolumab as part of a clinical trial or early access program.
3. 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, or active severe or unstable neuropsychiatric lupus.
4. Any other condition which the investigator deems to limit a patient's ability to understand the informed consent or complete the PROs.

Where it's running

• Research Site
  Alexandria, Egypt Recruiting
• Research Site
  Cairo, Egypt Recruiting
• Research Site
  Kuwait City, Kuwait Recruiting
• Research Site
  Mexico City, Mexico Recruiting
• Research Site
  Mérida, Mexico Recruiting
• Research Site
  Buenos Aires, Argentina Active not recruiting

Study contacts

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

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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.