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INTERSTELLAR - International Study Evaluating Lupus Outcomes After Anifrolumab Real World Use
NCT06314282 · AstraZeneca
In plain English
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Official title
INTERSTELLAR - Multi-National, Observational, Prospective, Post-Launch, Effectiveness Study Among SLE Patients Receiving Anifrolumab in Routine Clinical Practice
About this study
INTERSTELLAR is a multi-country, single-arm, observational, cohort study, with 1 year retrospective baseline data and 1 year of prospective follow-up. The study will be initiated on a country-by-country basis following the commercial launch of anifrolumab. The enrolment period is anticipated to be 12 months per country. In general, patients will enter the study between the first anifrolumab prescription and infusion (index), with follow-up until death, loss to follow-up, patient discontinuing the study, or end of study period (whichever occurs first). Relevant clinical and patient reported outcome (PRO) data collection for the entire follow up will continue for patients who have discontinued anifrolumab during the study, unless the patients have withdrawn their consent for participation in the study
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.
Study design
Enrollment target: 200 participants
Age groups: adult, older_adult
Timeline
Starts: 2024-10-22
Estimated completion: 2027-12-31
Last updated: 2026-05-26
Primary outcomes
- • PGA (Baseline (pre-infusion) Month 1, Month 3, Month 6, Month 12)
- • SLEDAI-2K (Baseline (pre-infusion) Month 1, Month 3, Month 6, Month 12)
- • CLASI (Baseline (pre-infusion) Month 1, Month 3, Month 6, Month 12)
Sponsor
AstraZeneca · industry
Contacts & investigators
ContactAstraZeneca Clinical Study Information Center · contact · information.center@astrazeneca.com · 1-877-240-9479
All locations (6)
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Aktobe, Kazakhstan
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Almaty, Kazakhstan
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Astana, Kazakhstan
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Pavlodar, Kazakhstan
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Semey, Kazakhstan
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Shymkent, Kazakhstan