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Clinical Trials in Mexico / NCT06314282
Recruiting Observational

INTERSTELLAR - International Study Evaluating Lupus Outcomes After Anifrolumab Real World Use

NCT06314282 · tracked via the Priya Life Science Mexico tracker
Sponsor
AstraZeneca
Phase
Observational
Started
2024-10-22
Last updated
2026-09-01

Condition(s) studied

Systemic Lupus Erythematosus (SLE)

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Aged 18 years or older at study enrolment. 2. Fulfilled the 2019 EULAR/ACR criteria1 for SLE at the time of study entry. 3. Prescribed anifrolumab for their SLE treatment for the first time, according to approved country-specific label. 4. It is important to note that a physician decision to prescribe anifrolumab will need to occur prior to any study-related discussion. 5. 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. 6. Provided informed consent to participate in the study. 7. Willing and able to participate in all required study evaluations and procedures. Exclusion Criteria: 1. Currently participating in an anifrolumab early access/compassionate use program or an interventional clinical trial with an investigational product. 2. Previous exposure to anifrolumab as part of a clinical trial or early access program. 3. 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. 4. Any other condition which the investigator deems to limit a patient's ability to understand the informed consent or complete the PROs.

Primary outcome measure(s)

  • PGA — 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 — 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 — 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 — 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 — 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 — 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

Trial sites (32)

FacilityCityRegionStatus
Research Site Buenos Aires Argentina Active Not Recruiting
Research Site Córdoba Argentina Active Not Recruiting
Research Site Guangzhou China Withdrawn
Research Site Hong Kong China Active Not Recruiting
Research Site Shenzhen China Withdrawn
Research Site Zhongshan China Active Not Recruiting
Research Site Zhuhai China Withdrawn
Research Site San José Costa Rica Active Not Recruiting
Research Site Alexandria Egypt Recruiting
Research Site Cairo Egypt Recruiting
Research Site Guatemala City Guatemala Active Not Recruiting
Research Site Aktobe Kazakhstan Active Not Recruiting
Research Site Almaty Kazakhstan Active Not Recruiting
Research Site Almaty Kazakhstan Withdrawn
Research Site Astana Kazakhstan Active Not Recruiting
Research Site Astana Kazakhstan Withdrawn
Research Site Pavlodar Kazakhstan Active Not Recruiting
Research Site Semey Kazakhstan Active Not Recruiting
Research Site Shymkent Kazakhstan Active Not Recruiting
Research Site Kuwait City Kuwait Recruiting
Research Site Mexico City Mexico Recruiting
Research Site Mérida Mexico Recruiting
Research Site Muscat Oman Active Not Recruiting
Research Site Doha Qatar Active Not Recruiting
Research Site ASIR Saudi Arabia Active Not Recruiting
Research Site Jeddah Saudi Arabia Active Not Recruiting
Research Site Riyadh Saudi Arabia Active Not Recruiting
Research Site Kaohsiung City Taiwan Active Not Recruiting
Research Site Taichung Taiwan Active Not Recruiting
Research Site Taichung Taiwan Withdrawn
Research Site Taipei Taiwan Active Not Recruiting
Research Site Taoyuan Taiwan Active Not Recruiting

More AstraZeneca trials in Mexico

Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Durvalumab Enrolling by invitation
A Global Study to Assess the Effects of Durvalumab + Domvanalimab Following Concurrent Chemoradiation in Participants With Stage III Unresectable NSCLC Active, not recruiting
An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2) Active, not recruiting
Phase 3 Study of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis Active, not recruiting
A Study to Investigate Outcomes With Elecoglipron Compared With Placebo in Adult Participants With Chronic Kidney Disease. Recruiting

Other trials for the same condition

A Study to Learn More About the Long-Term Safety of Litifilimab (BIIB059) Injections and it's Effects on Symptoms in Adults With Systemic Lupus Erythematosus (SLE) Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06314282 on ClinicalTrials.gov ↗ ← All trials in Mexico