Clinical trial NCT07005479: Long-Term Outcomes in SLE at Peking University People's Hospital
Official title: A Prospective Cohort Study on Long-Term Outcomes in Patients With Systemic Lupus Erythematosus at Peking University People's Hospital
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Systemic Lupus Erythematosus
Keywords: SLE
LLDAS
survival
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2025-06-05
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients must be over the age of 18 and competent to provide written consent.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Patients less than 18 years of age and patients who are unable to consent are excluded from the study.

Primary outcomes:
measure: Proportion of Patients Achieving and Sustaining Lupus Low Disease Activity State (LLDAS)
timeFrame: Approximately 5-10 years
Secondary outcomes:
measure: Organ Damage Accrual Measured by the SLICC/ACR Damage Index (SDI)
timeFrame: Annually over a 10-year follow-up period
measure: Lupus-Related Mortality Rate
timeFrame: Approximately 5-10 years
measure: Glucocorticoid-Sparing Effect
timeFrame: Assessed at each follow-up visit (up to 10 years)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Rheumatology and Immunology, Peking University People's Hospital
state: Beijing
Study officials:
References: