Systemic Lupus Erythematosus (SLE)INTERSTELLARNCT06314282
INTERSTELLAR - International Study Evaluating Lupus Outcomes After Anifrolumab Real World Use
An observational study of Systemic Lupus Erythematosus (SLE), run by AstraZeneca at 32 sites in 12 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus (SLE)
- How many people
- 200 participants
- Where
- 32 sitesin 12 countries
- Study dates
- 22 Oct 2024to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
32 sites in 12 countries. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
32 sites in 12 countries
Kazakhstan8 sites
- Active, not recruiting
Research Site
Aktobe
- Active, not recruiting
Research Site
Almaty
- Withdrawn
Research Site
Almaty
- Active, not recruiting
Research Site
Astana
- Withdrawn
Research Site
Astana
- Active, not recruiting
Research Site
Pavlodar
- Active, not recruiting
Research Site
Semey
- Active, not recruiting
Research Site
Shymkent
China5 sites
- Withdrawn
Research Site
Guangzhou
- Active, not recruiting
Research Site
Hong Kong
- Withdrawn
Research Site
Shenzhen
- Active, not recruiting
Research Site
Zhongshan
- Withdrawn
Research Site
Zhuhai
Taiwan5 sites
- Active, not recruiting
Research Site
Kaohsiung City
- Active, not recruiting
Research Site
Taichung
- Withdrawn
Research Site
Taichung
- Active, not recruiting
Research Site
Taipei
- Active, not recruiting
Research Site
Taoyuan
Saudi Arabia3 sites
- Active, not recruiting
Research Site
ASIR
- Active, not recruiting
Research Site
Jeddah
- Active, not recruiting
Research Site
Riyadh
Argentina2 sites
- Active, not recruiting
Research Site
Buenos Aires
- Active, not recruiting
Research Site
Córdoba
Egypt2 sites, 2 recruiting
- Recruiting
Research Site
Alexandria
- Recruiting
Research Site
Cairo
Mexico2 sites, 2 recruiting
- Recruiting
Research Site
Mérida
- Recruiting
Research Site
Mexico City
About this study
Official title: INTERSTELLAR - Multi-National, Observational, Prospective, Post-Launch, Effectiveness Study Among SLE Patients Receiving Anifrolumab in Routine Clinical Practice
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.
Read the detailed description
INTERSTELLAR is a multi-country, single-arm, observational, cohort study, with 1 year retrospective baseline data and 1 year of prospective follow-up. The study will be initiated on a country-by-country basis following the commercial launch of anifrolumab. The enrolment period is anticipated to be 12 months per country. In general, patients will enter the study between the first anifrolumab prescription and infusion (index), with follow-up until death, loss to follow-up, patient discontinuing the study, or end of study period (whichever occurs first). Relevant clinical and patient reported outcome (PRO) data collection for the entire follow up will continue for patients who have discontinued anifrolumab during the study, unless the patients have withdrawn their consent for participation in the study
- Conditions
- Systemic Lupus Erythematosus (SLE)
- Keywords
- SLE, Systemic lupus erythematosus, autoimmune disease, Lupus, Anifrolumab
- Medical subject headings
- Lupus Erythematosus, Systemic, Autoimmune Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
PGA
Physician's overall assessment of disease activity on a visual analog scale ranging from 0 (no activity) to 3 (severe activity).
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: Baseline (pre-infusion) Month 3, Month 6, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start22 Oct 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus Erythematosus (SLE)Studies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06314282
- Sponsor's protocol ID
- D3461R00072
- Acronym
- INTERSTELLAR
- Status last verified
- Aug 2026
- First submitted
- 11 Mar 2024
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INTERSTELLAR - Multi-National, Observational, Prospective, Post-Launch, Effectiveness Study Among SLE Patients Receiving Anifrolumab in Routine Clinical Practice
- ClinicalTrials.gov ID
- NCT06314282
- Acronym / sponsor ID
- INTERSTELLAR / D3461R00072
- Conditions
- Systemic Lupus Erythematosus (SLE)
- Keywords
- SLE, Systemic lupus erythematosus, autoimmune disease, Lupus, Anifrolumab
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 22 Oct 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
INTERSTELLAR is a multi-country, single-arm, observational, cohort study, with 1 year retrospective baseline data and 1 year of prospective follow-up. The study will be initiated on a country-by-country basis following the commercial launch of anifrolumab. The enrolment period is anticipated to be 12 months per country. In general, patients will enter the study between the first anifrolumab prescription and infusion (index), with follow-up until death, loss to follow-up, patient discontinuing the study, or end of study period (whichever occurs first). Relevant clinical and patient reported outcome (PRO) data collection for the entire follow up will continue for patients who have discontinued anifrolumab during the study, unless the patients have withdrawn their consent for participation in the study
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PGA
Time frame: Baseline (pre-infusion) Month 1, Month 3, Month 6, Month 12
Physician's overall assessment of disease activity on a visual analog scale ranging from 0 (no activity) to 3 (severe activity).
SLEDAI-2K
Time frame: Baseline (pre-infusion) Month 1, Month 3, Month 6, Month 12
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.
CLASI
Time frame: Baseline (pre-infusion) Month 1, Month 3, Month 6, Month 12
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.
FACIT-Fatigue
Time frame: Baseline (pre-infusion) Month 1, Month 3, Month 6, Month 12
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
LupusQoL
Time frame: Baseline (pre-infusion) Month 3, Month 6, Month 12
A 34-item questionnaire on a verbal rating scale covering several domains, including daily activities, pain, fatigue and sleep in relation to lupus symptoms.
EQ-5D-5L
Time frame: Baseline (pre-infusion) Month 3, Month 6, Month 12
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AstraZeneca Clinical Study Information Center contact
32 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus Erythematosus (SLE), run by AstraZeneca at 32 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in Kazakhstan, China, Taiwan, Saudi Arabia, Argentina and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PGA (time frame: Baseline (pre-infusion) Month 1, Month 3, Month 6, Month 12). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.