NCT06485674Completed
Long-Term Organ Damage: Anifrolumab Versus Real-World Standard of Care in Adult Patients With Active Systemic Lupus Erythematosus
Long-Term Organ Damage: Anifrolumab Versus Real-World Standard of Care in Adult Patients With Active Systemic Lupus Erythematosus (LASER) An External Comparator Arm Study for the TULIP Trials Using the University of Toronto Lupus Clinic Cohort
Source: ClinicalTrials.gov · Last updated 22 Apr 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 561 (actual)
- First submitted
- 27 Jun 2024
- Start date
- 9 May 2024
- Primary completion date
- 24 Jun 2025
- Lead sponsor
- AstraZeneca
- Diseases
- Lupus (SLE)
- NCT number
- NCT06485674
What you commit to
- Study type: Observational
- Participants enrolled: 561
- From 9 May 2024 to the primary completion date, 24 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 alcohol consumption ≥14 units/week at index date or ≤1 year prior to index date
Other illness
- Record of persistent, new or recurrent nephrotic syndrome, chronic dialysis, or renal transplant at index date.
Lab values
- 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:
Other
- 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:
Who the study is looking for
- 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.
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.