An observational study in Systemic Lupus Erythematosus (SLE), sponsored by AstraZeneca. Recruiting at 32 sites in 12 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by AstraZeneca · Observational
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.
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follow up will continue for patients who have discontinued anifrolumab during the study, unless the patients have withdrawn their consent for participation in the study
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.
Exclusion Criteria:
PGA
Physician's overall assessment of disease activity on a visual analog scale ranging from 0 (no activity) to 3 (severe activity).
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: Baseline (pre-infusion) Month 3, Month 6, Month 12
Plan to share: 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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Lupus Erythematosus, Systemic→
AstraZeneca