Long-Term Organ Damage: Anifrolumab Versus Real-World Standard of Care in Adult Patients With Act… (NCT06485674) | Clinical Trial Compass
CompletedNot Applicable
Long-Term Organ Damage: Anifrolumab Versus Real-World Standard of Care in Adult Patients With Active Systemic Lupus Erythematosus
Canada561 participantsStarted 2024-05-09
Plain-language 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).
Who can participate
SexALL
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Inclusion criteria
✓. 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
✕. 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.