Long-Term Organ Damage in Adult Patients With Active Systemic Lupus ErythematosusLASERNCT06485674
Long-Term Organ Damage: Anifrolumab Versus Real-World Standard of Care in Adult Patients With Active Systemic Lupus Erythematosus
An observational study of Long-Term Organ Damage in Adult Patients With Active Systemic Lupus Erythematosus, run by AstraZeneca at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Long-Term Organ Damage in Adult Patients With Active Systemic Lupus Erythematosus
- How many people
- 561 participants
- Where
- 1 siteCanada
- Study dates
- 9 May 2024to 24 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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).
Read the 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 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). Patients in the University of Toronto Lupus Clinic will be indexed at the first date of clinical assessment within the patient enrollment period for which they satisfy all eligibility criteria and are receiving at least one eligible SOC treatment (i.e., their 'index assessment') and will be followed up until the earliest occurrence of death, loss to follow-up, UTLC disenrollment, or end of study period.
- Keywords
- Anifrolumab, Active Systemic Lupus Erythematosus, Long-Term Organ Damage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Tulip Trial Group | Patients who initiated 300 mg of anifrolumab in TULIP (Treatment of Uncontrolled Lupus via the Interferon Pathway)-1 or -2. | |
| Toronto Lupus Cohort Group | Participants who received RW Standard Of Care for SLE from the University of Toronto Lupus Clinic (UTLC) registry. |
What is being measured
The primary outcome is the main question the study is designed to answer.
SLICC/ACR damage index (SDI) at week 208
Organ Damage measured using the SDI . The SDI is designed to assess irreversible damage across 12 organ systems in SLE patients, independently of cause or attribution.
Measured: 208 weeks
Secondary outcomes (4)
SDI at week 208 by organ damage at baseline
To estimate the effect of anifrolumab plus SOC in TULIP compared to RW SOC on organ damage accrual as measured by SDI at 208 weeks post-treatment initiation in the following subgroups: patients with no organ damage at baseline, and patients with any organ damage at baseline.
Measured: 208 weeks
Time to first organ damage progression as measured by SDI.
To estimate effect of anifrolumab plus SOC in TULIP compared to RW SOC on time to first organ damage progression as measured by SDI.
Measured: 208 weeks
Cumulative steroid intake
To estimate the effect of anifrolumab plus SOC in TULIP compared to RW SOC on cumulative steroid intake (prednisone equivalent) up to 208 weeks post-treatment initiation.
Measured: 208 weeks
Average daily steroid dose
To estimate the effect of anifrolumab plus SOC in TULIP compared to RW SOC on average daily steroid dose (prednisone equivalent) at 208 weeks post-treatment initiation.
Measured: 208 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start9 May 2024
- Primary completion24 Jun 2025
- Study completion24 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long-Term Organ Damage in Adult Patients With Active Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 561 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IQVIA Pvt. Ltd, University Health Network, Toronto
- Responsible party
- Sponsor
- Investigators
- Zahi Touma, Dr, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06485674
- Sponsor's protocol ID
- D3461R00077
- Acronym
- LASER
- Status last verified
- Apr 2026
- First submitted
- 27 Jun 2024
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06485674
- Acronym / sponsor ID
- LASER / D3461R00077
- Keywords
- Anifrolumab, Active Systemic Lupus Erythematosus, Long-Term Organ Damage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 561 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- IQVIA Pvt. Ltd, University Health Network, Toronto
- Study start
- 9 May 2024 (actual)
- Primary completion
- 24 Jun 2025 (actual)
- Study completion
- 24 Jun 2025 (actual)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 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). Patients in the University of Toronto Lupus Clinic will be indexed at the first date of clinical assessment within the patient enrollment period for which they satisfy all eligibility criteria and are receiving at least one eligible SOC treatment (i.e., their 'index assessment') and will be followed up until the earliest occurrence of death, loss to follow-up, UTLC disenrollment, or end of study period.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tulip Trial Group | – | –Patients who initiated 300 mg of anifrolumab in TULIP (Treatment of Uncontrolled Lupus via the Interferon Pathway)-1 or -2. |
| Toronto Lupus Cohort Group | – | –Participants who received RW Standard Of Care for SLE from the University of Toronto Lupus Clinic (UTLC) registry. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
SLICC/ACR damage index (SDI) at week 208
Time frame: 208 weeks
Organ Damage measured using the SDI . The SDI is designed to assess irreversible damage across 12 organ systems in SLE patients, independently of cause or attribution.
4 secondary outcomes
SDI at week 208 by organ damage at baseline
Time frame: 208 weeks
Time to first organ damage progression as measured by SDI.
Time frame: 208 weeks
Cumulative steroid intake
Time frame: 208 weeks
Average daily steroid dose
Time frame: 208 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- D3461R00077\_CSR synopsis\_RedactedLink provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zahi Touma, Dr principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Long-Term Organ Damage in Adult Patients With Active Systemic Lupus Erythematosus, run by AstraZeneca at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SLICC/ACR damage index (SDI) at week 208 (time frame: 208 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.