Evaluating lupus outcomes after using Anifrolumab in real-world settings

INTERSTELLAR - Multi-National, Observational, Prospective, Post-Launch, Effectiveness Study Among SLE Patients Receiving Anifrolumab in Routine Clinical Practice

This study is testing how well Anifrolumab works for people with lupus when added to their usual treatment, focusing on improvements in their symptoms over a year.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: AstraZeneca (Industry-sponsored)
• Drugs / interventions: anifrolumab, cyclophosphamide
• Locations: 6 sites (Aktobe and 5 other locations)
• Trial ID: NCT06314282 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who have been newly prescribed Anifrolumab for their SLE treatment.

Not a fit: Patients currently involved in other clinical trials or those with prior exposure to Anifrolumab 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 SLE, potentially improving treatment strategies.

How similar studies have performed: While this study is observational and aims to generate real-world evidence, similar studies have shown promise in evaluating treatment outcomes for autoimmune diseases.

Eligibility criteria

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 this trial is running

Aktobe and 5 other locations

• Research Site — Aktobe, Kazakhstan (Recruiting)
• Research Site — Almaty, Kazakhstan (Recruiting)
• Research Site — Astana, Kazakhstan (Recruiting)
• Research Site — Pavlodar, Kazakhstan (Recruiting)
• Research Site — Semey, Kazakhstan (Recruiting)
• Research Site — Shymkent, Kazakhstan (Recruiting)

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center

Conditions Systemic Lupus Erythematosus; SLE; Systemic lupus erythematosus; autoimmune disease; Lupus; Anifrolumab