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A multicenter, prospective, observational cohort study with natural follow-up in patients with systemic lupus erythematosus

A multicenter, prospective, observational cohort study with natural follow-up in patients with systemic lupus erythematosus

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600123373
Enrollment
Unknown
Registered
2026-04-26
Start date
2026-04-30
Completion date
Unknown
Last updated
2026-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic lupus erythematosus

Interventions

Sponsors

First Affiliated Hospital of Kunming Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.All subjects were SLE patients recruited from each center between January 2025 and December 2027 who voluntarily signed informed consent forms; 2.Aged 18–65 years, either sex; 3.Diagnosis consistent with the 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria or the 2019 EULAR/ACR SLE classification criteria; 4.Clinically diagnosed with SLE for at least 12 weeks prior to enrollment; 5.Educational level of primary school or above, proficient in Mandarin Chinese with capacity to comprehend scale contents, and capable of completing the questionnaires.

Exclusion criteria

Exclusion criteria: 1.Diagnosed with schizophrenia, mental retardation, alcohol abuse, alcohol dependence, or other psychoactive substance dependence; 2.History of major organic brain diseases, including trauma, tumor, stroke, infection, contagious disease, epilepsy, or definite neurodegenerative disorders; 3.Comorbid with other autoimmune diseases meeting ACR classification criteria for rheumatoid arthritis, systemic sclerosis, Sjögren's syndrome (primary or secondary), other connective tissue diseases, or drug-induced SLE; 4.Patients with severe cardiac, hepatic, renal, or pulmonary insufficiency; 5.Women who are pregnant, lactating, or planning pregnancy.

Design outcomes

Primary

MeasureTime frame
Systemic Lupus Erythematosus Disease Activity?Physician Global Assessment?Lupus Low Disease Activity State?Depression Scale ?Anxiety Scale?Cognitive Function;

Secondary

MeasureTime frame
Functional Magnetic Resonance Imaging,Neuroelectrophysiological Examination;Somatic Symptom Scale;

Countries

China

Contacts

Public Contactjianxu

First Affiliated Hospital of Kunming Medical University

jianxu777@126.com+86 138 8856 6797

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026