Can a lupus drug shield organs from Long-Term harm?
NCT ID NCT06485674
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study looked at whether the drug anifrolumab, when added to standard lupus treatments, can reduce long-term organ damage compared to standard care alone. Researchers analyzed data from 561 adults with active lupus, comparing those who took anifrolumab in earlier trials to similar patients from a real-world clinic. The goal was to see if anifrolumab helps prevent irreversible damage to organs like the kidneys and heart.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- anifrolumab
- What this could lead to
- If successful, this could show that anifrolumab helps prevent or slow long-term organ damage in people with active lupus.
- What could go wrong
- This is an observational study using data from past trials and a real-world clinic, not a new randomized trial. Results may not prove cause and effect, and benefits may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
561 people
The number who actually took part.
- Started
-
May 2024
- Finished
-
Jun 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
All patients who initiated 300mg of anifrolumab in TULIP-1 or -2 will be included in the active treatment arm of this ECA study. To identify a comparator cohort of patients in the UTLC who would be considered eligible for the TULIP trials, all patients in the UTLC who were active in the database during the study time period (1 January 1995 to 31 December 2023) will be extracted,4 and all key eligibility criteria from TULIP-1 and -2 will be applied to patients in the UTLC.
- Ages
-
Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria for UTLC: 1. Aged 18 through 70 years at index date. 2. Weight ≥40.0 kg at index date. 3. 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. 4. SLEDAI-2K score ≥6 points (Table 8 in Appendix) at index date. 5. No record of current pregnancy at index date. 6. 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: 1. Corticosteroid dose \>40 mg/day (oral prednisone equivalent) at index date. 2. Any record of receiving any biologic agent (e.g., anifrolumab, belimumab, rituximab, abatacept) at index date or within 4 weeks prior to index date. 3. Any record of malignancy at any point prior to index date, except skin malignancy ≥1 year prior to index date. 4. Record of persistent, new or recurrent nephrotic syndrome, chronic dialysis, or renal transplant at index date. 5. 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: 6. Record of alcohol consumption ≥14 units/week at index date or ≤1 year prior to index date
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Research Site
Toronto, Ontario, M5G 1L7, Canada
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