Clinical performance study of PS-PLA1 assay reagent for SLE

JRCT ID: jRCT1030230668

Registered date:29/02/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: SLE, non-SLE connective tissue diseases, non-connective tissue diseases
• Date of first enrollment: 29/02/2024
• Target sample size: 300
• Study type: Observational

Outcome(s)

• Primary Outcome: Discriminatory evaluation of SLE using PS-PLA1

Secondary Outcome

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.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Include 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

Exclude 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

Related Information

• Primary Sponsor: Fujio Keishi