INTERSTELLAR - International Study Evaluating Lupus Outcomes After Anifrolumab Real World Use

Launched by ASTRAZENECA · Mar 11, 2024

Keywords

ClinConnect Summary

The INTERSTELLAR study is a research trial designed to learn more about the effects of a medication called Anifrolumab for people with Systemic Lupus Erythematosus (SLE), a chronic autoimmune disease. This study aims to gather important information about how well Anifrolumab works when added to standard treatments that patients are already receiving. It will specifically look at how it helps with skin problems related to lupus, as well as other symptoms. The study will take place in multiple countries, including Qatar, Mexico, and Egypt, ensuring that the results can be compared across different locations.

To participate in the trial, you need to be at least 18 years old and have a confirmed diagnosis of lupus according to specific criteria. You should be starting Anifrolumab for the first time, as prescribed by your doctor. There are some exclusions, such as currently being part of another clinical trial or having certain severe health conditions. If you join the study, you can expect to have regular check-ups and assessments to monitor your health and how well the treatment is working. Your participation will help doctors understand the real-world benefits of Anifrolumab for lupus patients like you.

Gender

ALL

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.