Status:
COMPLETED
Long-Term Organ Damage: Anifrolumab Versus Real-World Standard of Care in Adult Patients With Active Systemic Lupus Erythematosus
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
IQVIA Pvt. Ltd
University Health Network, Toronto
Conditions:
Long-Term Organ Damage in Adult Patients With Active Systemic Lupus Erythematosus
Eligibility:
All Genders
Brief 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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Inclusion Criteria for UTLC:
- Aged 18 through 70 years at index date.
- Weight ≥40.0 kg at index date.
- Diagnosis of paediatric or adult SLE ≥24 weeks prior to index date using ≥4 of the 11 modified ACR classification criteria at least one of which must be positive antinuclear antibody test, anti-dsDNA antibodies, or anti-Smith antibody elevated to above normal level.
- SLEDAI-2K score ≥6 points (Table 8 in Appendix) at index date.
- No record of current pregnancy at index date.
- Valid measurement of SDI (Table 9 in Appendix) at index date.
- Exclusion Criteria:
- Selected key exclusion criteria from the TULIP trials have been adapted to the RW setting and will be applied to patients in the UTLC. Patients who meet any of the following criteria will be excluded from the study:
- Corticosteroid dose \>40 mg/day (oral prednisone equivalent) at index date.
- Any record of receiving any biologic agent (e.g., anifrolumab, belimumab, rituximab, abatacept) at index date or within 4 weeks prior to index date.
- Any record of malignancy at any point prior to index date, except skin malignancy ≥1 year prior to index date.
- Record of persistent, new or recurrent nephrotic syndrome, chronic dialysis, or renal transplant at index date.
- Serum creatinine \>2.0 mg/dL (or \>181 μmol/L) at index date.
- The following additional exclusion criteria may be applied to the study cohort at the time of analysis, if it is judged that their application will not significantly reduce the sample size available:
- Record of alcohol consumption ≥14 units/week at index date or ≤1 year prior to index date
Exclusion
Key Trial Info
Start Date :
May 9 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 24 2025
Estimated Enrollment :
561 Patients enrolled
Trial Details
Trial ID
NCT06485674
Start Date
May 9 2024
End Date
June 24 2025
Last Update
July 14 2025
Active Locations (1)
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1
Research Site
Toronto, Ontario, Canada, M5G 1L7