NCT06314282 INTERSTELLAR - International Study Evaluating Lupus Outcomes After Anifrolumab Real World Use
| NCT ID | NCT06314282 |
| Status | Recruiting |
| Phase | — |
| Sponsor | AstraZeneca |
| Condition | Systemic Lupus Erythematosus (SLE) |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-10-22 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2024-10-22 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06314282 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Systemic Lupus Erythematosus (SLE). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06314282 currently recruiting?
Yes, NCT06314282 is actively recruiting participants. Contact the research team at information.center@astrazeneca.com for enrollment information.
Where is the NCT06314282 trial being conducted?
This trial is being conducted at Aktobe, Kazakhstan, Almaty, Kazakhstan, Astana, Kazakhstan, Pavlodar, Kazakhstan and 2 additional locations.
Who is sponsoring the NCT06314282 clinical trial?
NCT06314282 is sponsored by AstraZeneca. The trial plans to enroll 200 participants.
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