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Clinical efficacy of low-dose rituximab combined with low-dose hormone in the treatment of mild to moderate refractory pemphigus: a prospective, single-center, randomized, parallel controlled trial

Clinical efficacy of low-dose rituximab combined with low-dose hormone in the treatment of mild to moderate refractory pemphigus: a prospective, single-center, randomized, parallel controlled trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300069742
Enrollment
Unknown
Registered
2023-03-24
Start date
2021-01-01
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

pemphigus

Interventions

Experimental group:200mg Rituximab
Control group:Immunosuppressants
Control group2:500mg Rituximab

Sponsors

Dermatology Hospital of Southern Medical University, Guangzhou, China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1) Patients who meet the diagnostic criteria for pemphigus (a: clinical manifestations of skin, mucous membrane flaccid blisters, erosion, Nissl sign positive; b histopathological examination showed intraepidermal blisters and acantholysis; c direct immunofluorescence examination showed acanthocyte IgG, C3 reticular deposition); 2) adult patients aged 18-80 years; 3) mild to moderate pemphigus (PDAI (Pemphigus Disease Area Index, pemphigus disease area index) score, < = 45 points); 4) the first RTX treatment; 5) signed informed consent; 6) can be treated as planned and followed up;

Exclusion criteria

Exclusion criteria: Patients who had previously received RTX or RTX for treatment of relapse; patients aged 80 years; patients with medication contraindications, including severe cardiovascular disease, severe liver and kidney damage, severe active infection, previous severe infusion reactions, history of severe allergy to related drugs, history of cancer, pregnant and lactating women, and recently vaccinated or planned vaccination.

Design outcomes

Primary

MeasureTime frame
Pemphigus Disease Area Index;Cumulative hormonal dose;Time to disease control;Time to reach complete response;

Secondary

MeasureTime frame
Percent peripheral blood B lymphocytes;Anti-Dsg3 titer;Anti-Dsg1 titer;

Countries

China

Contacts

Public ContactYongfeng Chen

Dermatology Hospital of Southern Medical University, Guangzhou, China

gdcyf@163.com13802920269

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026