Systemic Lupus ErythematosusSEVERUSNCT06759519
Clinical and Demographic Features of Patients With Moderate to Severe Active Systemic Lupus Erythematosus in Russia
An observational study of Systemic Lupus Erythematosus, run by AstraZeneca at 32 sites in Russia.
Trial summary
This is a multicenter observational retrospective-prospective study consisting of retrospective and prospective phases. Trial will include 2 visits for obtaining the patient's demographic and clinical data: the 1st is retrospective and the 2nd is prospective. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Systemic Lupus Erythematosus
- How many people
- 637 participants
- Where
- 32 sitesRussia
- Study dates
- 30 Aug 2024to 19 Sep 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: It is planned to enrol ~ 600 patients with moderate to severe SLE. Before that approximately 1000 patients with confirmed diagnosis of SLE will be screened (retrospective phase).
Who may be able to join
- Patients with the diagnosis of SLE (ICD code: M32) confirmed by medical records;
- Patients with availability of data of at least one visit to the clinic in the medical records in the last 24 months prior to inclusion;
- Age ≥ 18 years at the time of last patient's visit to the clinic.
- Additional inclusion criteria for the prospective phase are:
- Signed and dated written informed consent in accordance with ICH-GCP and local law prior to inclusion in the prospective phase of the study;
- Disease activity measured with SLEDAI-2K ≥ 6 despite of standard treatment at the time of inclusion in the prospective phase of the study
Who cannot join
- Regular use of genetically engineered biological drugs for SLE treatment within the last 24 months prior to inclusion;
- Participation in any interventional trial since the last patient's visit to the clinic;
- Presence of lupus nephritis class III/IV ± V at the moment of the last patient's visit to the clinic;
- Presence of neuropsychiatric lupus at the moment of the last patient's visit to the clinic.
- Additional exclusion criteria for the prospective phase are:
- Current use of genetically engineered biological drugs for SLE treatment;
Show all 10Show fewer
- Current participation in any interventional trial;
- Presence of lupus nephritis Class III/IV ± V at the moment of patient's visit;
- Presence of neuropsychiatric lupus at the moment of patient's visit;
- An acute or chronic disease that, in the opinion of the investigator, limits the ability of patient to provide data on his/her health or participate in this study or influence the interpretation of the results.
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
Russia32 sites
Research Site
Barnaul
Research Site
Belgorod
Research Site
Chelyabinsk
Research Site
Grozny
Research Site
Irkutsk
Research Site
Izhevsk
Research Site
Kaliningrad
Research Site
Kazan'
Research Site
Kemerovo
Research Site
Krasnodar
Research Site
Makhachkala
Research Site
Moscow
Research Site
Murmansk
Research Site
Nizny Novgorod
Research Site
Novosibirsk
Research Site
Omsk
Research Site
Orenburg
Research Site
Penza
Research Site
Perm
Research Site
Petrozavodsk
Research Site
Ryazan
Research Site
Saint-Petrburg
Research Site
Samara
Research Site
Saransk
Research Site
Saratov
Research Site
Surgut
Research Site
Tula
Research Site
Ufa
Research Site
Ulyanovsk
Research Site
Volgograd
Research Site
Yaroslavl
Research Site
Yekaterinburg
About this study
Official title: An Observational Multicenter Retrospective-prospective Study of Patients With Active Moderate to Severe SLE
This is a multicenter observational retrospective-prospective study consisting of retrospective and prospective phases. Trial will include 2 visits for obtaining the patient's demographic and clinical data: the 1st is retrospective and the 2nd is prospective. The study will involve approximately 50 sites of the Russian Federation; in each site about 20 patients will be recruited. The total planned size of study population will be approximately 1000 patients enrolled to the retrospective phase of the study, from which ~ 600 patients will be enrolled to the prospective phase.
Read the detailed description
Systemic lupus erythematosus (SLE) is a systemic autoimmune rheumatic disease with variable clinical manifestations and an unpredictable course, affecting any organs or systems, which quite often develops over several months or years, with persistent or, conversely, rapidly changing clinical manifestations, an undulating course, alternating remissions and flares.
Currently, in Russia there is no exact data on the number of patients with active moderate to severe SLE in the population, since there is no unified system for regular monitoring of patients with SLE in the country. The systematic information about complications and comorbidities, about the treatment approaches and their effectiveness in the Russian population is also absent.
The Russian Federation consists of 85 regions with a total population of more than 145 million people. The regions differ in ethnic composition, age, gender, climate, ecology, economic level, prevalence of SLE in general and moderate to severe SLE in particular.
Thus, there is a need to perform a large-scale observational study in regions of the country with a sufficient size of population to obtain information on moderate to severe SLE epidemiology, clinical and demographic characteristics, to describe main clinical outcomes and evaluate existing associations between observed treatment patterns and clinical outcomes in real clinical practice.
Trial will include 2 visits for obtaining the patient's demographic and clinical data: the 1st is retrospective and the 2nd is prospective. To allow wide data coverage the study will involve approximately 50 sites of Russian Federation; in each site about 20 patients will be recruited.
Overall expected duration of the study (from the first patient inclusion to the last patient last visit) is about 13 months or until 1000 patients will be included in the retrospective phase and ~ 600 patients - in the prospective phase This observational study does not imply any intervention into a routine clinical practice, including choice of treatment modality or special methods of investigation.
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Systemic lupus erythematosus, SLE
- Medical subject headings
- Lupus Erythematosus, Systemic
What is being measured
The primary outcome is the main question the study is designed to answer.
disease activity status at the time of patient visit to the doctor measured with SLEDAI-2K, expressed as the mean SLEDAI-2K total score at Visit 2.
In order to achieve primary objective, the mean SLEDAI-2K total score at Visit 2 will be calculated among patients with moderate to severe SLE (i.e. SLEDAI-2K total score ≥6 measured on the Visit 2) who provided informed consent and were enrolled to the prospective phase. The Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) is a clinical index for the measurement of disease activity in SLE. The modified index SLEDAI-2K was introduced and validated in 2002; it allows the documentation of persistent activity disease in rash, mucous membrane ulcers, alopecia, and proteinuria. 4 activity categories have been defined on the basis of the SLEDAI-2K total score (higher scores indicate more damage): no activity (0 points); low activity (1-4 points); moderate activity (5-10 points), and high activity (>10 points).
Measured: patient's visit to the doctor (Visit 2 -prospective data collection)
Secondary outcomes (21)
1. Mean age at the inclusion into the study
Measured: inclusion into the study
2. Proportion of patients aged 18-44, 45-64, and ≥65 years at the inclusion into the study
Measured: inclusion into the study
3. Mean age at the SLE diagnosis
Measured: within 24 months prior to inclusion into the study
4. Mean and median SLE duration, years
Measured: from the SLE diagnosis to the Visit 1
5. Proportion of men and women
Measured: inclusion of a patient into retrospective part of the study (Visit 1)
6. Proportion of patients from each residential region of Russia
Measured: inclusion of a patient into retrospective part of the study (Visit 1)
7. Mean SLEDAI-2K activity total score at Visit 1 (if available)
The Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) is a clinical index for the measurement of disease activity in SLE. The modified index SLEDAI-2K was introduced and validated in 2002; it allows the documentation of persistent activity disease in rash, mucous membrane ulcers, alopecia, and proteinuria. 4 activity categories have been defined on the basis of the SLEDAI-2K total score (higher scores indicate more damage): no activity (0 points); low activity (1-4 points); moderate activity (5-10 points), and high activity (>10 points).
Measured: inclusion of a patient into retrospective part of the study (Visit 1)
8. The proportion of patients with each SLE activity category based on SLEDAI-2K total score at Visit 1 (if available):
- No activity (total score 0);
- Low (total score 1-4);
- Moderate (total score 5-10);
- High (total score >10); The Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) is a clinical index for the measurement of disease activity in SLE. The modified index SLEDAI-2K was introduced and validated in 2002; it allows the documentation of persistent activity disease in rash, mucous membrane ulcers, alopecia, and proteinuria. 4 activity categories have been defined on the basis of the SLEDAI-2K total score (higher scores indicate more damage): no activity (0 points); low activity (1-4 points); moderate activity (5-10 points), and high activity (>10 points).
Measured: inclusion of a patient into retrospective part of the study (Visit 1)
9. The proportion of patients with each SLE activity category based on SLEDAI-2K total score at Visit 2:
- Moderate (total score 5-10);
- High (total score >10). The Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) is a clinical index for the measurement of disease activity in SLE. The modified index SLEDAI-2K was introduced and validated in 2002; it allows the documentation of persistent activity disease in rash, mucous membrane ulcers, alopecia, and proteinuria. 4 activity categories have been defined on the basis of the SLEDAI-2K total score (higher scores indicate more damage): no activity (0 points); low activity (1-4 points); moderate activity (5-10 points), and high activity (>10 points).
Measured: patient's visit to the doctor (prospective part of the study)
10. Mean SLICC/ACR damage index score by each domain and total score at Visit 2
The Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SLICC/ACR damage index or SDI) is a 42-item questionnaire concerning long-term damage due to SLE in 12 organ systems for use in clinical research studies [14, 15]. The global score (range from 0 to 49, with higher scores indicating more damage) is the sum of the scores for all 12 organ systems.
Measured: patient's visit to the doctor (Visit 2 -prospective data collection)
11. The proportion of patients with various organ domain involvement:
- Skin and mucosa involvement;
- Joints involvement;
- Hematological disorders;
- Immunological activity;
- Renal involvement;
- Serositis (pleurisy, pericarditis etc.).
Measured: Retrospective and prospective data collection (Visit 1, Visit 2)
12. The proportion of patients with various comorbidities and concomitant treatment
Measured: patient's visit to the doctor (Visit 2 -prospective data collection)
13. The proportion of patients with various groups of SLE treatment medications in anamnesis (at Visit 1)
Measured: inclusion of a patient into retrospective part of the study (Visit 1)
14. The proportion of patients taking various groups and drugs of SLE treatment medications (at Visit 2);
Measured: patient's visit to the doctor (Visit 2 -prospective data collection)
15. The mean (median) of oral glucocorticosteroids (OGCS) daily dose,
mg/day (prednisolone equivalent) (evaluated in patients who are taking OGCS);
Measured: Retrospective and prospective data collection (Visit 1, Visit 2)
16. The proportion of patients received OGCS daily dose (prednisolone equivalent) more than 5 mg/day;
Measured: Retrospective and prospective data collection (Visit 1, Visit 2)
17. Proportion of patient receiving immunosuppressive agents (azathioprine, cyclophosphamide, methotrexate, mycophenolate mofetil, cyclosporine, calcineurin inhibitors etc.) as a single agent or combination
Measured: Retrospective and prospective data collection (Visit 1, Visit 2)
18. The mean value of immunological laboratory parameters
C3, C4, anti-dsDNA, ANA
Measured: Visit 2 (within around a year from inclusion into the study)
19. The mean value of hematology laboratory parameters
leukocytes, platelets
Measured: patient's visit to the doctor (Visit 2 -prospective data collection)
20. The proportion of patients with leukopenia <4,000/mm³;
Measured: patient's visit to the doctor (Visit 2 -prospective data collection)
21. The proportion of patients with thrombocytopenia <100,000/mm³.
Measured: patient's visit to the doctor (Visit 2 -prospective data collection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start30 Aug 2024
- Primary completion19 Sep 2025
- Study completion19 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 637 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06759519
- Sponsor's protocol ID
- D3461R00092
- Acronym
- SEVERUS
- Status last verified
- Jun 2026
- First submitted
- 28 Aug 2024
- Last updated
- 9 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Multicenter Retrospective-prospective Study of Patients With Active Moderate to Severe SLE
- ClinicalTrials.gov ID
- NCT06759519
- Acronym / sponsor ID
- SEVERUS / D3461R00092
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Systemic lupus erythematosus, SLE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 637 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 30 Aug 2024 (actual)
- Primary completion
- 19 Sep 2025 (actual)
- Study completion
- 19 Sep 2025 (actual)
- First posted
- 6 Jan 2025 (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 a multicenter observational retrospective-prospective study consisting of retrospective and prospective phases. Trial will include 2 visits for obtaining the patient's demographic and clinical data: the 1st is retrospective and the 2nd is prospective. The study will involve approximately 50 sites of the Russian Federation; in each site about 20 patients will be recruited. The total planned size of study population will be approximately 1000 patients enrolled to the retrospective phase of the study, from which ~ 600 patients will be enrolled to the prospective phase.
Detailed description
Systemic lupus erythematosus (SLE) is a systemic autoimmune rheumatic disease with variable clinical manifestations and an unpredictable course, affecting any organs or systems, which quite often develops over several months or years, with persistent or, conversely, rapidly changing clinical manifestations, an undulating course, alternating remissions and flares.
Currently, in Russia there is no exact data on the number of patients with active moderate to severe SLE in the population, since there is no unified system for regular monitoring of patients with SLE in the country. The systematic information about complications and comorbidities, about the treatment approaches and their effectiveness in the Russian population is also absent.
The Russian Federation consists of 85 regions with a total population of more than 145 million people. The regions differ in ethnic composition, age, gender, climate, ecology, economic level, prevalence of SLE in general and moderate to severe SLE in particular.
Thus, there is a need to perform a large-scale observational study in regions of the country with a sufficient size of population to obtain information on moderate to severe SLE epidemiology, clinical and demographic characteristics, to describe main clinical outcomes and evaluate existing associations between observed treatment patterns and clinical outcomes in real clinical practice.
Trial will include 2 visits for obtaining the patient's demographic and clinical data: the 1st is retrospective and the 2nd is prospective. To allow wide data coverage the study will involve approximately 50 sites of Russian Federation; in each site about 20 patients will be recruited.
Overall expected duration of the study (from the first patient inclusion to the last patient last visit) is about 13 months or until 1000 patients will be included in the retrospective phase and ~ 600 patients - in the prospective phase This observational study does not imply any intervention into a routine clinical practice, including choice of treatment modality or special methods of investigation.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- It is planned to enrol ~ 600 patients with moderate to severe SLE. Before that approximately 1000 patients with confirmed diagnosis of SLE will be screened (retrospective phase).
Key inclusion criteria (6 listed)
- Patients with the diagnosis of SLE (ICD code: M32) confirmed by medical records;
- Patients with availability of data of at least one visit to the clinic in the medical records in the last 24 months prior to inclusion;
- Age ≥ 18 years at the time of last patient's visit to the clinic.
- Signed and dated written informed consent in accordance with ICH-GCP and local law prior to inclusion in the prospective phase of the study;
- Disease activity measured with SLEDAI-2K ≥ 6 despite of standard treatment at the time of inclusion in the prospective phase of the study
Key exclusion criteria (10 listed)
- Regular use of genetically engineered biological drugs for SLE treatment within the last 24 months prior to inclusion;
- Participation in any interventional trial since the last patient's visit to the clinic;
- Presence of lupus nephritis class III/IV ± V at the moment of the last patient's visit to the clinic;
- Presence of neuropsychiatric lupus at the moment of the last patient's visit to the clinic.
- Current use of genetically engineered biological drugs for SLE treatment;
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
disease activity status at the time of patient visit to the doctor measured with SLEDAI-2K, expressed as the mean SLEDAI-2K total score at Visit 2.
Time frame: patient's visit to the doctor (Visit 2 -prospective data collection)
In order to achieve primary objective, the mean SLEDAI-2K total score at Visit 2 will be calculated among patients with moderate to severe SLE (i.e. SLEDAI-2K total score ≥6 measured on the Visit 2) who provided informed consent and were enrolled to the prospective phase. The Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) is a clinical index for the measurement of disease activity in SLE. The modified index SLEDAI-2K was introduced and validated in 2002; it allows the documentation of persistent activity disease in rash, mucous membrane ulcers, alopecia, and proteinuria. 4 activity categories have been defined on the basis of the SLEDAI-2K total score (higher scores indicate more damage): no activity (0 points); low activity (1-4 points); moderate activity (5-10 points), and high activity (>10 points).
21 secondary outcomes
1. Mean age at the inclusion into the study
Time frame: inclusion into the study
2. Proportion of patients aged 18-44, 45-64, and ≥65 years at the inclusion into the study
Time frame: inclusion into the study
3. Mean age at the SLE diagnosis
Time frame: within 24 months prior to inclusion into the study
4. Mean and median SLE duration, years
Time frame: from the SLE diagnosis to the Visit 1
5. Proportion of men and women
Time frame: inclusion of a patient into retrospective part of the study (Visit 1)
6. Proportion of patients from each residential region of Russia
Time frame: inclusion of a patient into retrospective part of the study (Visit 1)
7. Mean SLEDAI-2K activity total score at Visit 1 (if available)
Time frame: inclusion of a patient into retrospective part of the study (Visit 1)
8. The proportion of patients with each SLE activity category based on SLEDAI-2K total score at Visit 1 (if available):
Time frame: inclusion of a patient into retrospective part of the study (Visit 1)
9. The proportion of patients with each SLE activity category based on SLEDAI-2K total score at Visit 2:
Time frame: patient's visit to the doctor (prospective part of the study)
10. Mean SLICC/ACR damage index score by each domain and total score at Visit 2
Time frame: patient's visit to the doctor (Visit 2 -prospective data collection)
11. The proportion of patients with various organ domain involvement:
Time frame: Retrospective and prospective data collection (Visit 1, Visit 2)
12. The proportion of patients with various comorbidities and concomitant treatment
Time frame: patient's visit to the doctor (Visit 2 -prospective data collection)
13. The proportion of patients with various groups of SLE treatment medications in anamnesis (at Visit 1)
Time frame: inclusion of a patient into retrospective part of the study (Visit 1)
14. The proportion of patients taking various groups and drugs of SLE treatment medications (at Visit 2);
Time frame: patient's visit to the doctor (Visit 2 -prospective data collection)
15. The mean (median) of oral glucocorticosteroids (OGCS) daily dose,
Time frame: Retrospective and prospective data collection (Visit 1, Visit 2)
16. The proportion of patients received OGCS daily dose (prednisolone equivalent) more than 5 mg/day;
Time frame: Retrospective and prospective data collection (Visit 1, Visit 2)
17. Proportion of patient receiving immunosuppressive agents (azathioprine, cyclophosphamide, methotrexate, mycophenolate mofetil, cyclosporine, calcineurin inhibitors etc.) as a single agent or combination
Time frame: Retrospective and prospective data collection (Visit 1, Visit 2)
18. The mean value of immunological laboratory parameters
Time frame: Visit 2 (within around a year from inclusion into the study)
19. The mean value of hematology laboratory parameters
Time frame: patient's visit to the doctor (Visit 2 -prospective data collection)
20. The proportion of patients with leukopenia <4,000/mm³;
Time frame: patient's visit to the doctor (Visit 2 -prospective data collection)
21. The proportion of patients with thrombocytopenia <100,000/mm³.
Time frame: patient's visit to the doctor (Visit 2 -prospective data collection)
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 9 Jul 2026.
- D3461R00092\_CSR synopsis\_RedactedLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Related trials for Systemic Lupus Erythematosus
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
RecruitingPhase 4
Dapagliflozin in Active Lupus Nephritis
Lupus Nephritis (LN)
RecruitingObservational study
Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
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.
The record lists no contact. Use the official record to reach the sponsor.
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus Erythematosus, run by AstraZeneca at 32 sites in Russia.
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 10 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 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in Russia. 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?
disease activity status at the time of patient visit to the doctor measured with SLEDAI-2K, expressed as the mean SLEDAI-2K total score at Visit 2. (time frame: patient's visit to the doctor (Visit 2 -prospective data collection)). 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 9 Jul 2026.