INTERSTELLAR - International Study Evaluating Lupus Outcomes After Anifrolumab Real World Use
INTERSTELLAR
INTERSTELLAR - Multi-National, Observational, Prospective, Post-Launch, Effectiveness Study Among SLE Patients Receiving Anifrolumab in Routine Clinical Practice
1 other identifier
observational
200
12 countries
32
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2024
Typical duration for all trials
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2024
CompletedFirst Posted
Study publicly available on registry
March 18, 2024
CompletedStudy Start
First participant enrolled
October 22, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
July 17, 2026
July 1, 2026
3.2 years
March 11, 2024
July 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
PGA
Physician's overall assessment of disease activity on a visual analog scale ranging from 0 (no activity) to 3 (severe activity).
Baseline (pre-infusion) Month 1, Month 3, Month 6, Month 12
SLEDAI-2K
24 lupus-related (weighted) items to assess disease activity, rated as 'present' or 'absent' and attributed to active lupus. Scored on a scale from 0 to 105, with 0 being inactive disease.
Baseline (pre-infusion) Month 1, Month 3, Month 6, Month 12
CLASI
Skin activity and damage assessment completed by physician by scoring each specific area as indicated on the form. The higher the score, the worse the activity/damage.
Baseline (pre-infusion) Month 1, Month 3, Month 6, Month 12
FACIT-Fatigue
A 13-item questionnaire to assess the impact of fatigue on a 5-point verbal rating scale. Scores range from 0 to 52; a higher score indicates les fatigue
Baseline (pre-infusion) Month 1, Month 3, Month 6, Month 12
LupusQoL
A 34-item questionnaire on a verbal rating scale covering several domains, including daily activities, pain, fatigue and sleep in relation to lupus symptoms.
Baseline (pre-infusion) Month 3, Month 6, Month 12
EQ-5D-5L
5-item questionnaire measuring 5 dimensions of general health status on a verbal rating, and a single visual analog scale about overall perceived health today
Baseline (pre-infusion) Month 3, Month 6, Month 12
Eligibility Criteria
10 to 50 patients will be enrolled per country from academic, community and hospital outpatient settings, to maximize the representation of the study population. This will result in approximately 180-200 patients in total allowing for sufficient precision when analysing the total cohort and to explore subgroups of interest.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (32)
Research Site
Buenos Aires, Argentina
Research Site
Córdoba, Argentina
Research Site
Guangzhou, China
Research Site
Hong Kong, China
Research Site
Shenzhen, China
Research Site
Zhongshan, China
Research Site
Zhuhai, China
Research Site
San José, Costa Rica
Research Site
Alexandria, Egypt
Research Site
Cairo, Egypt
Research Site
Guatemala City, Guatemala
Research Site
Aktobe, Kazakhstan
Research Site
Almaty, Kazakhstan
Research Site
Almaty, Kazakhstan
Research Site
Astana, Kazakhstan
Research Site
Astana, Kazakhstan
Research Site
Pavlodar, Kazakhstan
Research Site
Semey, Kazakhstan
Research Site
Shymkent, Kazakhstan
Research Site
Kuwait City, Kuwait
Research Site
Mexico City, Mexico
Research Site
Mérida, Mexico
Research Site
Muscat, Oman
Research Site
Doha, Qatar
Research Site
ASIR, Saudi Arabia
Research Site
Jeddah, Saudi Arabia
Research Site
Riyadh, Saudi Arabia
Research Site
Kaohsiung City, Taiwan
Research Site
Taichung, Taiwan
Research Site
Taichung, Taiwan
Research Site
Taipei, Taiwan
Research Site
Taoyuan, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2024
First Posted
March 18, 2024
Study Start
October 22, 2024
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
July 17, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.