Lupus Erythematosus, SystemicNCT03144063
Improving the Assessment of SLE Disease Activity
An observational study of Lupus Erythematosus, Systemic and SLE, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Physicians' assessment of disease activity in SLE is fundamental but challenging. The Systemic Lupus Erythematosus Disease Activity Index (SLEDAI-2K) is one of the most commonly used disease activity indices. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lupus Erythematosus, Systemic, SLE
- How many people
- 247 participants
- Where
- 1 siteCanada
- Study dates
- 11 Jul 2017to 4 Jun 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Objective I Initial Development and Validation of SLEDAI-2KG This is a retrospective validation study of SLEDAI-2KG using the University of Toronto Lupus Clinic (TLC) database. Clinical and laboratory data is collected according to a standard protocol at regular intervals (2 to 6 months between visits) and stored on a computer database. Objective II Further retrospective validation of SLEDAI-2KG using BLISS trial data. All patients in GSK BLISS-52 (N=865) and BLISS-76 (N=819) were assessed at regular intervals and data including clinical and laboratory features of SLE, medications and in particular corticosteroids was collected and will be used in the validation of SLEDAI-2KG. Objective III Assessment of concurrent construct validity of SLEDAI-2KG prospectively in the TLC Cohort Patients from the TLC with active disease with a flare (increase in SLEDAI-2K by at least 4) that requires an increase in the dose of prednisone to ≥15 mg/day or initiation of prednisone at ≥15 mg/day.
Who may be able to join
- Objective I:
- ≥4 American College of Rheumatology (ACR) criteria or 3 ACR criteria plus a typical histological lesion of SLE on renal or skin biopsy
- Clinician's diagnosis based on his/her assessment
- Patients from the Toronto Lupus Clinic with regular follow-up, defined as having follow up visits at 3 and 6 months from the baseline visit (1st study visit).
- Objective II:
- Participant in the BLISS-52 and BLISS-76 trials
Show all 10Show fewer
- Objective III:
- ≥4 American College of Rheumatology (ACR) criteria or 3 ACR criteria plus a typical histological lesion of SLE on renal or skin biopsy
- Increase in SLEDAI-2K ≥4
- Clinician's diagnosis based on his/her assessment
Who cannot join
- Objective I and III:
- Patients with missing follow up visits at 3 and 6 months from the baseline visit (1st study visit).
- Patients with missing data in the charts for all visits.
- Objective II:
- Participants who did not complete the trial and therefore have missing data points for primary endpoint measures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving the Assessment of Systemic Lupus Erythematosus Disease Activity
Physicians' assessment of disease activity in SLE is fundamental but challenging. The Systemic Lupus Erythematosus Disease Activity Index (SLEDAI-2K) is one of the most commonly used disease activity indices. Clinical trials experience suggested that the disease activity instruments did not function well on their own, and composite measures were developed to address this issue. This approach has been adopted after learning from clinical trials that the absence of a robust sensitive index is a major flaw when designing a trial. Another issue with clinical trials is the confounding effect of corticosteroids, which to date have been the most effective treatment for the management of lupus. However, unregulated use of corticosteroids in drug trials decrease the investigator's ability to differentiate between the tested drugs and placebo as they appear to enhance response among the placebo arm and thus mask the effect of the tested drug.
In this study, the aim is to develop and validate a new index, SLEDAI-2K Glucocorticosteroid Index (SLEDAI-2KG). It is very challenging to evaluate improvement in drug trials in the context of the standard of care treatment which includes corticosteroids. This novel index, SLEDAI-2KG, will help to overcome the confounding effect of corticosteroids and to allow for more accurate description of disease improvement and thus facilitate accurate investigations of new therapeutic agents.
Read the detailed description
Objectives:
- To describe the development and initial validation of the SLEDAI-2KG using the Toronto Lupus Cohort (TLC) database.
- To conduct further validation of SLEDAI-2KG using BLISS trial data.
- To assess concurrent construct validity of SLEDAI-2KG prospectively in the University of Toronto Lupus Clinic.
Study design:
- Objective one is a single center study aiming to derive a new index, SLEDAI-2KG, based on SLEDAI-2K. Scoring of SLEDAI-2KG will be determined in this study.
- Objective two is a retrospective analysis conducted on prospectively collected data from two clinical trials, BLISS-52 and BLISS-76.
- Objective three is a single centre prospective study.
Study Population and Sampling Methods:
Objective I patient selection: Patients with active disease, SLEDAI-2K ≥0, will be identified in the TLC database. All patients must have follow up visits at 3 and 6 months.
Objective II: Data from BLISS-52 and BLISS-76 trials will be used. Objective III patient selection: Patients followed at the Toronto Lupus Clinic from May 2017 to December 2017. Patients will be identified based on active disease with a flare (increase in SLEDAI-2K by at least 4 requiring an increase in the dose of prednisone to ≥ 15 mg/day or initiation of prednisone at ≥ 15 mg/day).
Objective III patient selection: Patients followed at the Toronto Lupus Clinic from May 2017 to December 2017. The investigator will identify patients with active disease with a flare (increase in SLEDAI-2K by at least 4 requiring an increase in the dose of prednisone to ≥ 15 mg/day or initiation of prednisone at ≥ 15 mg/day).
Data Sources:
The University of Toronto Lupus Cohort dataset and GSK BLISS-52 and BLISS-76 trial data The Toronto Lupus Cohort (TLC) is the largest lupus cohort in Canada, and more than 1600 patients have been enrolled in this cohort. Patients in the TLC are seen at regular intervals (2-6 months apart) and data, including laboratory and clinical parameters important to lupus, is collected using a well-defined protocol.
Data Analysis Methods:
In objective I - Phase 1 will focus on the identification of scenarios of real patients to derive weight scores for Glucocorticosteroid (GCS). Phase 2 will focus on the development of SLEDAI-2KG (derivation of an equation to explain the link between SLEDAI-2K and GCS doses) and phase 3 focused on SLEDAI-2KG validation.
The analysis of the initial validation of SLEDAI-2KG will be conducted on the selected patients from the TLC. Improved patients (responders) will be identified based on SLEDAI-2K definition of improvement and further will be studied by calculating the SLEDAI-2KG using the above described models. The mean change of SLEDAI-2K scores and the mean change of SLEDAI-2KG scores in the responders will be studied. Using the SLEDAI-2K responders as "Gold Standard", it will be determined if SLEDAI-2KG responders are true responders and not false responders.
Concurrent construct validity: A clinician (external construct) who does not know the patients and will evaluate each patient's record (electronic record and medical chart) and assign a clinical activity score for each assessment according to the following scale: improved, same, and worse, using standardized predefined definitions. The correlation between the external construct and the change in SLEDAI-2K and SLEDAI-2KG scores will be studied. Using the clinician scoring of disease activity-Improved as "Gold Standard", the results of SLEDAI-2K and SLEDAI-2KG responders will be analyzed by constructing two 2x2 tables.
Sample Size for 3 objectives:
Sample Size 1: The sample size calculation of needed scenarios was based on the assumption of reliability (Intra-class Correlation Coefficient (ICC)) ≥ 0.80 with a standard error of 0.05 and 3 raters. The required minimum was 46 scenarios.
Sample Size 2: For objective two all data available from the BLISS-52 and BLISS-76 trials will be used.
Sample Size 3: For objective three the investigator's target sample size is 100 patients and to achieve this number at least 18 months will be required and subsequently a 6 months period for follow-up for each patients. Based on the COSMIN recommendations, a sample size ≥100 is recommended in this step
- Conditions
- Lupus Erythematosus, Systemic, SLE
- Keywords
- Disease Activity, SLEDAI-2K
- Medical subject headings
- Lupus Erythematosus, Systemic
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 |
|---|---|---|
| Toronto Lupus Cohort | Objective 1 and 3 Cohort: * ≥4 American College of Rheumatology (ACR) criteria or 3 ACR criteria plus a typical histological lesion of SLE on renal or skin biopsy * Clinician's diagnosis based on his/her assessment * Patients from the Toronto Lupus Clinic with regular follow-up, defined as having follow up visits at 3 and 6 months from the baseline visit (1st study visit). | |
| BLISS-52 Cohort | Objective 2 Cohort: Validation of the SLEDAI-2KG will be completed on BLISS-52 trial data. The extracted trial data consists of data on all patients that participated in the trial. | |
| BLISS-76 Cohort | Objective 2 Cohort: Validation of the SLEDAI-2KG will be completed on BLISS-76 trial data. The extracted trial data consists of data on all patients that participated in the trial. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective I - Initial Development and Validation of Systemic Lupus Erythematosus Disease Activity Index-2000 Glucocorticosteroid (SLEDAI-2KG)
The new index SLEDAI-2KG will be validated against the old index Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) in the TLC cohort. Improved patients (responders) will be identified based on SLEDAI-2K definition of improvement (decrease in the total score by ≥4).
Clinician scoring on a Likert scale (external construct) for disease activity - Improvement based on predefined definitions
Measured: 3 months
Objective II - Further validation of Systemic Lupus Erythematosus Disease Activity Index-2000 Glucocorticosteroid (SLEDAI-2KG) using BLISS trial data
SLEDAI-2KG will be further validated using BLISS-52 and BLISS-7S trial data on all patients that were enrolled. The primary endpoint in both trials was SLE Responder Index (SRI). The SRI incorporates the Safety of Estrogens in Lupus Erythematosus-National Assessment-SLEDAI (SELENA-SLEDAI), British Isles Lupus Assessment Group (BILAG), and Physician Global Assessment (PGA). The primary outcome of this objective is the SRI-modified: The SRI-modified will include the 2nd and 3rd components of SRI, but replace the SELENA-SLEDAI with the SLEDAI-2KG.
Measured: 5 months
Objective IIIA - Assessment of concurrent construct validity of Systemic Lupus Erythematosus Disease Activity Index-2000 Glucocorticosteroid (SLEDAI-2KG) prospectively in the University of Toronto Lupus Clinic
Improved patients (responders) will be identified based on Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) definition of improvement (decrease in the total score by ≥4).
Measured: 8 months
Objective IIIB - Identification of Systemic Lupus Erythematosus Disease Activity Index-2000 Glucocorticosteroid (SLEDAI-2KG) Responders
SLEDAI-2KG improved patients (responders) will be identified based on the definition of improvement (decrease in the total score by ≥4).
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study start11 Jul 2017
- Primary completion4 Jun 2020
- Study completion4 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus Erythematosus, SystemicStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Prospective
- Enrolment
- 247 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, Zahi Touma, University Health Network, Toronto
- Investigators
- Zahi Touma, MD PhD, Principal investigator, University Health Network and University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03144063
- Sponsor's protocol ID
- 15-9195
- Status last verified
- Mar 2025
- First submitted
- 28 Apr 2017
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Assessment of Systemic Lupus Erythematosus Disease Activity
- ClinicalTrials.gov ID
- NCT03144063
- Acronym / sponsor ID
- 15-9195
- Conditions
- Lupus Erythematosus, Systemic, SLE
- Keywords
- Disease Activity, SLEDAI-2K
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 247 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- 11 Jul 2017 (actual)
- Primary completion
- 4 Jun 2020 (actual)
- Study completion
- 4 Jun 2020 (actual)
- First posted
- 8 May 2017 (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.
Physicians' assessment of disease activity in SLE is fundamental but challenging. The Systemic Lupus Erythematosus Disease Activity Index (SLEDAI-2K) is one of the most commonly used disease activity indices. Clinical trials experience suggested that the disease activity instruments did not function well on their own, and composite measures were developed to address this issue. This approach has been adopted after learning from clinical trials that the absence of a robust sensitive index is a major flaw when designing a trial. Another issue with clinical trials is the confounding effect of corticosteroids, which to date have been the most effective treatment for the management of lupus. However, unregulated use of corticosteroids in drug trials decrease the investigator's ability to differentiate between the tested drugs and placebo as they appear to enhance response among the placebo arm and thus mask the effect of the tested drug.
In this study, the aim is to develop and validate a new index, SLEDAI-2K Glucocorticosteroid Index (SLEDAI-2KG). It is very challenging to evaluate improvement in drug trials in the context of the standard of care treatment which includes corticosteroids. This novel index, SLEDAI-2KG, will help to overcome the confounding effect of corticosteroids and to allow for more accurate description of disease improvement and thus facilitate accurate investigations of new therapeutic agents.
Detailed description
Objectives:
- To describe the development and initial validation of the SLEDAI-2KG using the Toronto Lupus Cohort (TLC) database.
- To conduct further validation of SLEDAI-2KG using BLISS trial data.
- To assess concurrent construct validity of SLEDAI-2KG prospectively in the University of Toronto Lupus Clinic.
Study design:
- Objective one is a single center study aiming to derive a new index, SLEDAI-2KG, based on SLEDAI-2K. Scoring of SLEDAI-2KG will be determined in this study.
- Objective two is a retrospective analysis conducted on prospectively collected data from two clinical trials, BLISS-52 and BLISS-76.
- Objective three is a single centre prospective study.
Study Population and Sampling Methods:
Objective I patient selection: Patients with active disease, SLEDAI-2K ≥0, will be identified in the TLC database. All patients must have follow up visits at 3 and 6 months.
Objective II: Data from BLISS-52 and BLISS-76 trials will be used. Objective III patient selection: Patients followed at the Toronto Lupus Clinic from May 2017 to December 2017. Patients will be identified based on active disease with a flare (increase in SLEDAI-2K by at least 4 requiring an increase in the dose of prednisone to ≥ 15 mg/day or initiation of prednisone at ≥ 15 mg/day).
Objective III patient selection: Patients followed at the Toronto Lupus Clinic from May 2017 to December 2017. The investigator will identify patients with active disease with a flare (increase in SLEDAI-2K by at least 4 requiring an increase in the dose of prednisone to ≥ 15 mg/day or initiation of prednisone at ≥ 15 mg/day).
Data Sources:
The University of Toronto Lupus Cohort dataset and GSK BLISS-52 and BLISS-76 trial data The Toronto Lupus Cohort (TLC) is the largest lupus cohort in Canada, and more than 1600 patients have been enrolled in this cohort. Patients in the TLC are seen at regular intervals (2-6 months apart) and data, including laboratory and clinical parameters important to lupus, is collected using a well-defined protocol.
Data Analysis Methods:
In objective I - Phase 1 will focus on the identification of scenarios of real patients to derive weight scores for Glucocorticosteroid (GCS). Phase 2 will focus on the development of SLEDAI-2KG (derivation of an equation to explain the link between SLEDAI-2K and GCS doses) and phase 3 focused on SLEDAI-2KG validation.
The analysis of the initial validation of SLEDAI-2KG will be conducted on the selected patients from the TLC. Improved patients (responders) will be identified based on SLEDAI-2K definition of improvement and further will be studied by calculating the SLEDAI-2KG using the above described models. The mean change of SLEDAI-2K scores and the mean change of SLEDAI-2KG scores in the responders will be studied. Using the SLEDAI-2K responders as "Gold Standard", it will be determined if SLEDAI-2KG responders are true responders and not false responders.
Concurrent construct validity: A clinician (external construct) who does not know the patients and will evaluate each patient's record (electronic record and medical chart) and assign a clinical activity score for each assessment according to the following scale: improved, same, and worse, using standardized predefined definitions. The correlation between the external construct and the change in SLEDAI-2K and SLEDAI-2KG scores will be studied. Using the clinician scoring of disease activity-Improved as "Gold Standard", the results of SLEDAI-2K and SLEDAI-2KG responders will be analyzed by constructing two 2x2 tables.
Sample Size for 3 objectives:
Sample Size 1: The sample size calculation of needed scenarios was based on the assumption of reliability (Intra-class Correlation Coefficient (ICC)) ≥ 0.80 with a standard error of 0.05 and 3 raters. The required minimum was 46 scenarios.
Sample Size 2: For objective two all data available from the BLISS-52 and BLISS-76 trials will be used.
Sample Size 3: For objective three the investigator's target sample size is 100 patients and to achieve this number at least 18 months will be required and subsequently a 6 months period for follow-up for each patients. Based on the COSMIN recommendations, a sample size ≥100 is recommended in this step
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Toronto Lupus Cohort | – | –Objective 1 and 3 Cohort: * ≥4 American College of Rheumatology (ACR) criteria or 3 ACR criteria plus a typical histological lesion of SLE on renal or skin biopsy * Clinician's diagnosis based on his/her assessment * Patients from the Toronto Lupus Clinic with regular follow-up, defined as having follow up visits at 3 and 6 months from the baseline visit (1st study visit). |
| BLISS-52 Cohort | – | –Objective 2 Cohort: Validation of the SLEDAI-2KG will be completed on BLISS-52 trial data. The extracted trial data consists of data on all patients that participated in the trial. |
| BLISS-76 Cohort | – | –Objective 2 Cohort: Validation of the SLEDAI-2KG will be completed on BLISS-76 trial data. The extracted trial data consists of data on all patients that participated in the trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Objective I Initial Development and Validation of SLEDAI-2KG This is a retrospective validation study of SLEDAI-2KG using the University of Toronto Lupus Clinic (TLC) database. Clinical and laboratory data is collected according to a standard protocol at regular intervals (2 to 6 months between visits) and stored on a computer database. Objective II Further retrospective validation of SLEDAI-2KG using BLISS trial data. All patients in GSK BLISS-52 (N=865) and BLISS-76 (N=819) were assessed at regular intervals and data including clinical and laboratory features of SLE, medications and in particular corticosteroids was collected and will be used in the validation of SLEDAI-2KG. Objective III Assessment of concurrent construct validity of SLEDAI-2KG prospectively in the TLC Cohort Patients from the TLC with active disease with a flare (increase in SLEDAI-2K by at least 4) that requires an increase in the dose of prednisone to ≥15 mg/day or initiation of prednisone at ≥15 mg/day.
Key inclusion criteria (10 listed)
- ≥4 American College of Rheumatology (ACR) criteria or 3 ACR criteria plus a typical histological lesion of SLE on renal or skin biopsy
- Clinician's diagnosis based on his/her assessment
- Patients from the Toronto Lupus Clinic with regular follow-up, defined as having follow up visits at 3 and 6 months from the baseline visit (1st study visit).
- Participant in the BLISS-52 and BLISS-76 trials
- ≥4 American College of Rheumatology (ACR) criteria or 3 ACR criteria plus a typical histological lesion of SLE on renal or skin biopsy
Key exclusion criteria (5 listed)
- Patients with missing follow up visits at 3 and 6 months from the baseline visit (1st study visit).
- Patients with missing data in the charts for all visits.
- Participants who did not complete the trial and therefore have missing data points for primary endpoint measures
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
Objective I - Initial Development and Validation of Systemic Lupus Erythematosus Disease Activity Index-2000 Glucocorticosteroid (SLEDAI-2KG)
Time frame: 3 months
The new index SLEDAI-2KG will be validated against the old index Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) in the TLC cohort. Improved patients (responders) will be identified based on SLEDAI-2K definition of improvement (decrease in the total score by ≥4). Clinician scoring on a Likert scale (external construct) for disease activity - Improvement based on predefined definitions
Objective II - Further validation of Systemic Lupus Erythematosus Disease Activity Index-2000 Glucocorticosteroid (SLEDAI-2KG) using BLISS trial data
Time frame: 5 months
SLEDAI-2KG will be further validated using BLISS-52 and BLISS-7S trial data on all patients that were enrolled. The primary endpoint in both trials was SLE Responder Index (SRI). The SRI incorporates the Safety of Estrogens in Lupus Erythematosus-National Assessment-SLEDAI (SELENA-SLEDAI), British Isles Lupus Assessment Group (BILAG), and Physician Global Assessment (PGA). The primary outcome of this objective is the SRI-modified: The SRI-modified will include the 2nd and 3rd components of SRI, but replace the SELENA-SLEDAI with the SLEDAI-2KG.
Objective IIIA - Assessment of concurrent construct validity of Systemic Lupus Erythematosus Disease Activity Index-2000 Glucocorticosteroid (SLEDAI-2KG) prospectively in the University of Toronto Lupus Clinic
Time frame: 8 months
Improved patients (responders) will be identified based on Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) definition of improvement (decrease in the total score by ≥4).
Objective IIIB - Identification of Systemic Lupus Erythematosus Disease Activity Index-2000 Glucocorticosteroid (SLEDAI-2KG) Responders
Time frame: 8 months
SLEDAI-2KG improved patients (responders) will be identified based on the definition of improvement (decrease in the total score by ≥4).
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 28 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Lupus Erythematosus, Systemic
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
RecruitingPhase 3
A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus
Lupus Erythematosus, Systemic
RecruitingPhase 2
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescents With Active Class III or IV Lupus Nephritis and the Safety and PK of Obinutuzumab in Pediatric Participants
Lupus Nephritis
Recruiting
Effect of Anifrolumab on Arterial Inflammation in Systemic Lupus Erythematosus Study
Systemic Lupus Erythematosus, Atherosclerosis Generalized
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
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, MD PhD principal investigator
University Health Network and University of 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 Lupus Erythematosus, Systemic and SLE, run by University Health Network, Toronto 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 10 inclusion and 5 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 28 Mar 2025. 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?
Objective I - Initial Development and Validation of Systemic Lupus Erythematosus Disease Activity Index-2000 Glucocorticosteroid (SLEDAI-2KG) (time frame: 3 months). The study lists 4 primary outcomes in all. 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 28 Mar 2025.