Clinical performance study of PS-PLA1 assay reagent for SLE

Clinical performance study of AIA-CL PS-PLA1 (Phosphatidylserine-specific Phos pholipase A1) assay reagent for systemic lupus erythematosus (SLE)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1030230668

Enrollment

300

Registered

2024-02-29

Start date

2024-02-29

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

SLE, non-SLE connective tissue diseases, non-connective tissue diseases

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: SLE patients (untreated, treated intervention), non-SLE connective tissue disease patients (rheumatoid arthritis, other antinuclear antibody-related connective tissue diseases [Sjogren's syndrome, systemic sclerosis, polymyositis/dermatomyositis, mixed connective tissue disease], antiphospholipid antibody syndrome), non-connective tissue disease subjects

Exclusion criteria

Exclusion criteria: 1) Patients with thyroid disorders (Graves' disease, thyroiditis, Plummer's disease, Hashimoto's disease) 2) Pregnant women 3) Non-connective tissue disease subjects who are antinuclear antibody positive

Design outcomes

Primary

Measure	Time frame
Discriminatory evaluation of SLE using PS-PLA1	—

Secondary

Measure	Time frame
Sensitivity, specificity, positive predictive value, negative predictive value, and area under the curve (AUC) by ROC analysis for PS-PLA1 and anti-ds-DNA antibodies. Transition of PS-PLA1, anti-ds-DNA antibodies, and SLEDAI values after therapeutic intervention in SLE patients.	—

Contacts

Public ContactHirofumi Shoda

The University of Tokyo Hospital

shodah-int@h.u-tokyo.ac.jp+81-338155411

Outcome results