INTERSTELLAR - International Study Evaluating Lupus Outcomes After Anifrolumab Real World
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
| Condition(s) | Systemic Lupus Erythematosus (SLE) |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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 |
| Who can participate | 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/compassiona |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | AstraZeneca |
| Locations | Aktobe, Kazakhstan; Almaty, Kazakhstan; Astana, Kazakhstan; Pavlodar, Kazakhstan; Semey, Kazakhstan; Shymkent, Kazakhstan |
| Start date | 2024-10-22 |
| NCT ID | NCT06314282 |
| Official listing | https://clinicaltrials.gov/study/NCT06314282 |