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Long-Term Organ Damage: Anifrolumab Versus Real-World Standard of Care in Adult Patients With Active Systemic Lupus Erythematosus

NCT06485674 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 561

Last updated 2026-04-22

No results posted yet for this study

Summary

This is an External control arm study to generate evidence on the comparative effect of anifrolumab plus Standard of Care in TULIP versus Real World Standard of Care on organ damage in adult patients with moderately to severely active Systemic lupus erythematosus (SLE). Patients who initiated 300 mg of anifrolumab in TULIP-1 or -2 will be indexed at the date of initiating anifrolumab and will be followed up until the earliest occurrence of death, loss to follow-up, trial dis-enrollment, or week 208 assessment (in LTE study).

Conditions

  • Long-Term Organ Damage in Adult Patients With Active Systemic Lupus Erythematosus

Sponsors & Collaborators

  • IQVIA Pvt. Ltd

    collaborator INDUSTRY

  • University Health Network, Toronto

    collaborator OTHER

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Zahi Touma, Dr · University Health Network, Toronto

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-09
Primary Completion
2025-06-24
Completion
2025-06-24

Countries

  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06485674 on ClinicalTrials.gov