Observes lupus patients treated with anifrolumab in routine care
Follows adults with lupus who receive anifrolumab alongside standard treatment in routine care.
Key facts
- Who runs it
- AstraZeneca
- Where
- Alexandria and Cairo, EgyptSee the 2 sitesAlso in 11 other countries, 27 sites
- Trial code
- Registry title
- INTERSTELLAR - International Study Evaluating Lupus Outcomes After Anifrolumab Real World Use
- Status
- Recruiting
- People taking part
- 200 people, planned
- Started
- 22 Oct 2024
- Expected to end
- 31 Dec 2027
- Type of study
- Observational
- Record updated
- 1 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with systemic lupus erythematosus (SLE) who have been prescribed anifrolumab for the first time in routine care.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- SLE that meets the 2019 EULAR/ACR criteria for SLE at study entry.
- Earlier treatment
- Anifrolumab prescribed for the first time. People who took it before in a clinical trial or early access program cannot join.
Main reasons for not taking part
- Taking part now in an anifrolumab early access or compassionate use program, or in a trial of an investigational product
- Earlier anifrolumab use in a clinical trial or early access program
- Severe or fast-worsening lupus kidney disease (Class III or IV glomerulonephritis needing induction therapy), or isolated Class V lupus nephritis
- Active severe or unstable lupus affecting the brain or nerves (neuropsychiatric lupus)
- A condition that limits understanding the consent form or completing the patient questionnaires
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- Aged 18 years or older at study enrolment
- Fulfilled the 2019 EULAR/ACR criteria1 for SLE at the time of study entry
- Prescribed anifrolumab for their SLE treatment for the first time, according to approved country-specific label
- It is important to note that a physician decision to prescribe anifrolumab will need to occur prior to any study-related discussion
- 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
- Provided informed consent to participate in the study
- Willing and able to participate in all required study evaluations and procedures
Who cannot take part
- Currently participating in an anifrolumab early access/compassionate use program or an interventional clinical trial with an investigational product
- Previous exposure to anifrolumab as part of a clinical trial or early access program
- 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
- Any other condition which the investigator deems to limit a patient's ability to understand the informed consent or complete the PROs
Where in Egypt
Also in 11 other countries, 27 sites
- AlexandriaHospital not named in the registryTaking people
- CairoHospital not named in the registryTaking people
About the trial
What the trial wants to find out
INTERSTELLAR study will generate critical prospective 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. The study will use clinical assessments that are relevant for SLE-treating physicians in routine clinical practice, as well as introduce a specific measure for skin manifestations to affirm the potency of anifrolumab in treating SLE-related skin manifestations. The study will use standardized objectives, inclusion/exclusion criteria and outcome measures across all countries participating in this study including GCC (Qatar, KSA), Mexico, CAMCAR (Costa Rica, Panama, Dominican Republic), Colombia, Argentina, Taiwan, and Egypt, and any other countries that may be included in the study, in order to facilitate a comparison and analysis across all countries included in this study.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- INTERSTELLAR - Multi-National, Observational, Prospective, Post-Launch, Effectiveness Study Among SLE Patients Receiving Anifrolumab in Routine Clinical Practice
- Plain-language title
- Observes lupus patients treated with anifrolumab in routine careGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 1 September 2026