NCT06314282Recruiting
INTERSTELLAR - International Study Evaluating Lupus Outcomes After Anifrolumab Real World Use
INTERSTELLAR - Multi-National, Observational, Prospective, Post-Launch, Effectiveness Study Among SLE Patients Receiving Anifrolumab in Routine Clinical Practice
Source: ClinicalTrials.gov · Last updated 1 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 11 Mar 2024
- Start date
- 22 Oct 2024
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- AstraZeneca
- Diseases
- Lupus (SLE)
- NCT number
- NCT06314282
What you commit to
- Study type: Observational
- Planned participants: 200
- From 22 Oct 2024 to the primary completion date, 31 Dec 2027
- 29 sites in 12 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Any other condition which the investigator deems to limit a patient's ability to understand the informed consent or complete the PROs.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (29)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Research Site Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Active, not recruiting |
| Research Site Coordinator of this site? Confirm its status | Córdoba | Argentina | Active, not recruiting |
| Research Site Coordinator of this site? Confirm its status | Guangzhou | China | Withdrawn |
| Research Site Coordinator of this site? Confirm its status | Hong Kong | China | Active, not recruiting |
| Research Site Coordinator of this site? Confirm its status | Shenzhen | China | Withdrawn |
| Research Site Coordinator of this site? Confirm its status | Zhongshan | China | Active, not recruiting |
| Research Site Coordinator of this site? Confirm its status | Zhuhai | China | Withdrawn |
| Research Site Coordinator of this site? Confirm its status | San José | Costa Rica | Active, not recruiting |
| Research Site Coordinator of this site? Confirm its status | Alexandria | Egypt | Recruiting |
| Research Site Coordinator of this site? Confirm its status | Cairo | Egypt | Recruiting |
| Research Site Coordinator of this site? Confirm its status | Guatemala City | Guatemala | Active, not recruiting |
| Research Site Coordinator of this site? Confirm its status | Kuwait City | Kuwait | Recruiting |
| Research Site Coordinator of this site? Confirm its status | Aktobe | Kazakhstan | Active, not recruiting |
| Research Site Coordinator of this site? Confirm its status | Almaty | Kazakhstan | Active, not recruiting |
| Research Site Coordinator of this site? Confirm its status | Astana | Kazakhstan | Active, not recruiting |
| Research Site Coordinator of this site? Confirm its status | Pavlodar | Kazakhstan | Active, not recruiting |
| Research Site Coordinator of this site? Confirm its status | Semey | Kazakhstan | Active, not recruiting |
| Research Site Coordinator of this site? Confirm its status | Shymkent | Kazakhstan | Active, not recruiting |
| Research Site Coordinator of this site? Confirm its status | Mérida | Mexico | Recruiting |
| Research Site Coordinator of this site? Confirm its status | Mexico City | Mexico | Recruiting |
| Research Site Coordinator of this site? Confirm its status | Muscat | Oman | Active, not recruiting |
| Research Site Coordinator of this site? Confirm its status | Doha | Qatar | Active, not recruiting |
| Research Site Coordinator of this site? Confirm its status | ASIR | Saudi Arabia | Active, not recruiting |
| Research Site Coordinator of this site? Confirm its status | Jeddah | Saudi Arabia | Active, not recruiting |
| Research Site Coordinator of this site? Confirm its status | Riyadh | Saudi Arabia | Active, not recruiting |
| Research Site Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Active, not recruiting |
| Research Site Coordinator of this site? Confirm its status | Taichung | Taiwan | Active, not recruiting |
| Research Site Coordinator of this site? Confirm its status | Taipei | Taiwan | Active, not recruiting |
| Research Site Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.