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Skin B cells in the progression from cutaneous lupus to systemic lupus

Skin B cells in the progression from cutaneous lupus to systemic lupus - CLE to SLE

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON56119
Enrollment
50
Registered
2023-11-17
Start date
2025-09-03
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Cutaneous lupus skin lupus

Interventions

None listed

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years. 2. Diagnosis of CLE is made by dermatologist based on clinical features and histopathological examination. 3. In case of a SLE, this diagnosis is made by a rheumatologist based on 2019 ACR/EULAR classification criteria for SLE. 4. Patients who have read, understood, and signed an informed consent document related to this specific study.

Exclusion criteria

Exclusion criteria: - Patients with any other dermatological of systemic disorder which would interfere with the results, at the discretion of the investigator. - Patients using topical corticosteroids and topical calcineurin inhibitors at biopsy site within one week prior to enrolment. - Patients who are or have been treated with specific B cell depleting/modifying therapies (Rituximab, Belimumab, Cyclophosphamide)in 12 months prior to inclusion.

Design outcomes

Primary

MeasureTime frame
Objective 1: Characterization of autoreactive B cells in CLE and SLE • Frequency and phenotype of autoreactive B cells in skin and circulation • Specificities of antibodies from cutaneous B cell supernatant in ELISA Objective 2: Determine the mechanisms for B cell tolerance breakthrough and plasma cell differentiation in the skin of CLE and SLE patients • Transcriptome of B cells in skin (scRNAseq) • B cell receptor repertoire of cutaneous B cells • Immune cell landscape of B cells in skin (imaging mass cytometry).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)