Systemic Lupus ErythematosusLOTUSNCT07005479
Long-Term Outcomes in SLE at Peking University People's Hospital
An observational study of Systemic Lupus Erythematosus, run by Peking University People's Hospital at 1 site in China.
Trial summary
This study aims to prospectively follow patients diagnosed with Systemic Lupus Erythematosus (SLE) at Peking University People's Hospital, assessing long-term outcomes such as disease activity, organ involvement, survival, and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 21 May 2020to 20 May 2032
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: All patients must be over the age of 18 and competent to provide written consent.
Who may be able to join
- All patients must meet at least one of the following classification criteria for Systemic Lupus Erythematosus (SLE):
- The 1997 American College of Rheumatology (ACR) Revised Classification Criteria; The 2012 Systemic Lupus International Collaborating Clinics (SLICC) Classification Criteria; The 2019 EULAR/ACR Classification Criteria for SLE. All patients must be over the age of 18 and competent to provide written consent.
Who cannot join
- Patients less than 18 years of age and patients who are unable to consent are excluded from the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Rheumatology and Immunology, Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Haihong Yao, MD, 010-88326666, yaohaihong@pku.edu.cn
About this study
Official title: A Prospective Cohort Study on Long-Term Outcomes in Patients With Systemic Lupus Erythematosus at Peking University People's Hospital
This study aims to prospectively follow patients diagnosed with Systemic Lupus Erythematosus (SLE) at Peking University People's Hospital, assessing long-term outcomes such as disease activity, organ involvement, survival, and quality of life. Findings will support individualized patient management and contribute to understanding disease progression in the Chinese population.
Read the detailed description
This single-center, prospective observational cohort study aims to evaluate the long-term clinical outcomes of patients diagnosed with SLE at Peking University People's Hospital. SLE is a chronic, heterogeneous autoimmune disease that can lead to cumulative organ damage, impaired quality of life, and premature mortality. Although disease control has improved with the advent of immunosuppressive therapies, predicting long-term outcomes remains a challenge.
The study will enroll adult SLE patients and follow them for a period of up to 10 years. Data will be collected at regular intervals, including clinical assessments, laboratory findings, treatment history, and patient-reported outcomes. A particular focus will be placed on measuring disease activity using validated indices such as the SLE Disease Activity Index (SLEDAI) and on evaluating the achievement and maintenance of Lupus Low Disease Activity State (LLDAS).
LLDAS is a validated treat-to-target goal associated with reduced damage accrual and improved prognosis. It will be assessed at each follow-up visit based on established criteria, including low disease activity (SLEDAI-2K ≤4 with no major organ activity), no new disease activity, low-dose glucocorticoid use (prednisone ≤7.5 mg/day or equivalent), and stable standard immunosuppressants. The frequency, duration, and determinants of achieving and sustaining LLDAS over time will be analyzed as a key outcome, alongside major organ involvement, flare rates, survival, and quality of life.
This study will provide real-world data on long-term disease trajectories in a Chinese tertiary hospital population and offer insights into predictors of favorable outcomes, guiding personalized disease management strategies and supporting the implementation of treat-to-target approaches in clinical practice.
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- SLE, LLDAS, survival
- Medical subject headings
- Lupus Erythematosus, Systemic
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients Achieving and Sustaining Lupus Low Disease Activity State (LLDAS)
LLDAS is defined according to the Asia Pacific Lupus Collaboration (APLC) criteria as meeting all of the following at a study visit:
SLEDAI-2K ≤4 with no activity in major organ systems (renal, CNS, cardiopulmonary, vasculitis, etc.)
No new features of lupus disease activity compared to the previous assessment
Physician Global Assessment (PGA) ≤1 (on a 0-3 scale)
Prednisone (or equivalent) dose ≤7.5 mg/day
Use of standard maintenance immunosuppressive drugs only
Measured: Approximately 5-10 years
Secondary outcomes (3)
Organ Damage Accrual Measured by the SLICC/ACR Damage Index (SDI)
Organ damage will be assessed using the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI). SDI ranges from 0 to 47, with higher scores indicating more severe, irreversible organ damage accrued since the onset of SLE. A score of 0 indicates no damage, while each additional point reflects cumulative damage in different organ systems.
Measured: Annually over a 10-year follow-up period
Lupus-Related Mortality Rate
Number and proportion of deaths directly attributable to SLE or its complications (e.g., infection, renal failure, cardiovascular events).
Measured: Approximately 5-10 years
Glucocorticoid-Sparing Effect
Proportion of patients achieving and maintaining prednisone (or equivalent) ≤7.5 mg/day without disease flare. Also evaluating cumulative steroid dose over time.
Measured: Assessed at each follow-up visit (up to 10 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start21 May 2020
- Primary completion20 May 2030 (estimated)
- Study completion20 May 2032 (estimated)
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 Peking University People's HospitalThe 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
- 1,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, He Jing, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07005479
- Sponsor's protocol ID
- SLE-PKUPHS
- Acronym
- LOTUS
- Status last verified
- May 2025
- First submitted
- 20 May 2025
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study on Long-Term Outcomes in Patients With Systemic Lupus Erythematosus at Peking University People's Hospital
- ClinicalTrials.gov ID
- NCT07005479
- Acronym / sponsor ID
- LOTUS / SLE-PKUPHS
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- SLE, LLDAS, survival
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 21 May 2020 (actual)
- Primary completion
- 20 May 2030 (estimated)
- Study completion
- 20 May 2032 (estimated)
- First posted
- 5 Jun 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 study aims to prospectively follow patients diagnosed with Systemic Lupus Erythematosus (SLE) at Peking University People's Hospital, assessing long-term outcomes such as disease activity, organ involvement, survival, and quality of life. Findings will support individualized patient management and contribute to understanding disease progression in the Chinese population.
Detailed description
This single-center, prospective observational cohort study aims to evaluate the long-term clinical outcomes of patients diagnosed with SLE at Peking University People's Hospital. SLE is a chronic, heterogeneous autoimmune disease that can lead to cumulative organ damage, impaired quality of life, and premature mortality. Although disease control has improved with the advent of immunosuppressive therapies, predicting long-term outcomes remains a challenge.
The study will enroll adult SLE patients and follow them for a period of up to 10 years. Data will be collected at regular intervals, including clinical assessments, laboratory findings, treatment history, and patient-reported outcomes. A particular focus will be placed on measuring disease activity using validated indices such as the SLE Disease Activity Index (SLEDAI) and on evaluating the achievement and maintenance of Lupus Low Disease Activity State (LLDAS).
LLDAS is a validated treat-to-target goal associated with reduced damage accrual and improved prognosis. It will be assessed at each follow-up visit based on established criteria, including low disease activity (SLEDAI-2K ≤4 with no major organ activity), no new disease activity, low-dose glucocorticoid use (prednisone ≤7.5 mg/day or equivalent), and stable standard immunosuppressants. The frequency, duration, and determinants of achieving and sustaining LLDAS over time will be analyzed as a key outcome, alongside major organ involvement, flare rates, survival, and quality of life.
This study will provide real-world data on long-term disease trajectories in a Chinese tertiary hospital population and offer insights into predictors of favorable outcomes, guiding personalized disease management strategies and supporting the implementation of treat-to-target approaches in clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients must be over the age of 18 and competent to provide written consent.
Key inclusion criteria (2 listed)
- All patients must meet at least one of the following classification criteria for Systemic Lupus Erythematosus (SLE):
- The 1997 American College of Rheumatology (ACR) Revised Classification Criteria; The 2012 Systemic Lupus International Collaborating Clinics (SLICC) Classification Criteria; The 2019 EULAR/ACR Classification Criteria for SLE. All patients must be over the age of 18 and competent to provide written consent.
Key exclusion criteria (1 listed)
- Patients less than 18 years of age and patients who are unable to consent are excluded from the study.
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
Proportion of Patients Achieving and Sustaining Lupus Low Disease Activity State (LLDAS)
Time frame: Approximately 5-10 years
LLDAS is defined according to the Asia Pacific Lupus Collaboration (APLC) criteria as meeting all of the following at a study visit: SLEDAI-2K ≤4 with no activity in major organ systems (renal, CNS, cardiopulmonary, vasculitis, etc.) No new features of lupus disease activity compared to the previous assessment Physician Global Assessment (PGA) ≤1 (on a 0-3 scale) Prednisone (or equivalent) dose ≤7.5 mg/day Use of standard maintenance immunosuppressive drugs only
3 secondary outcomes
Organ Damage Accrual Measured by the SLICC/ACR Damage Index (SDI)
Time frame: Annually over a 10-year follow-up period
Lupus-Related Mortality Rate
Time frame: Approximately 5-10 years
Glucocorticoid-Sparing Effect
Time frame: Assessed at each follow-up visit (up to 10 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
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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.
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 Systemic Lupus Erythematosus, run by Peking University People's Hospital at 1 site in China.
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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 5 Jun 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haihong Yao, MD (010-88326666, yaohaihong@pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients Achieving and Sustaining Lupus Low Disease Activity State (LLDAS) (time frame: Approximately 5-10 years). 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 5 Jun 2025.