INTERSTELLAR - International Study Evaluating Lupus Outcomes After Anifrolumab Real World Use
Recruiting · NCT06314282 · Observational (researchers observe without assigning treatment) · Lead sponsor: AstraZeneca
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- 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 it is running
32 locations listed.
- Research Site - ASIR, Saudi Arabia
- Research Site - Aktobe, Kazakhstan
- Research Site - Alexandria, Egypt
- Research Site - Almaty, Kazakhstan
- Research Site - Almaty, Kazakhstan
- Research Site - Astana, Kazakhstan
- Research Site - Astana, Kazakhstan
- Research Site - Buenos Aires, Argentina
- Research Site - Cairo, Egypt
- Research Site - Córdoba, Argentina
- Research Site - Doha, Qatar
- Research Site - Guangzhou, China
- Research Site - Guatemala City, Guatemala
- Research Site - Hong Kong, China
- Research Site - Jeddah, Saudi Arabia
- Research Site - Kaohsiung City, Taiwan
- Research Site - Kuwait City, Kuwait
- Research Site - Mexico City, Mexico
- Research Site - Muscat, Oman
- Research Site - Mérida, Mexico
- Research Site - Pavlodar, Kazakhstan
- Research Site - Riyadh, Saudi Arabia
- Research Site - San José, Costa Rica
- Research Site - Semey, Kazakhstan
- Research Site - Shenzhen, China
- Research Site - Shymkent, Kazakhstan
- Research Site - Taichung, Taiwan
- Research Site - Taichung, Taiwan
- Research Site - Taipei, Taiwan
- Research Site - Taoyuan, Taiwan
- Research Site - Zhongshan, China
- Research Site - Zhuhai, China