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Ultra-low-dose rituximab with glucocorticoids in patients with pemphigus study.

Ultra-low-dose rituximab with glucocorticoids in patients with pemphigus study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400090625
Enrollment
Unknown
Registered
2024-10-10
Start date
2023-06-07
Completion date
Unknown
Last updated
2024-10-15

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

Conditions

Pemphigus

Interventions

experimental group :Experimental group: 100 mg rituximab at week 0, week 2, and month 6 once, combined with glucocorticoid therapy
control group 1:Control group one: mycophenolate mofetil combined with glucocorticoid therapy.
control group 2:Control group two: 500 mg rituximab at week 0, week 2 once, combined with glucocorticoid therapy

Sponsors

Shandong Provincial Hospital for Skin Diseases & Shandong First Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients meeting the diagnostic criteria for pemphigus (a: clinical manifestations of flaccid vesicles and erosions on the skin and mucous membranes, positive Nissl sign; b histopathological examination showed intraepidermal blisters and acantholysis; c direct immunofluorescence Examination revealed IgG and C3 reticular deposition between spiny cells); 2. Adult patients aged 18-80; 3. Mild to severe pemphigus (PDAI (PemphigusDiseaseAreaIndex, Pemphigus Disease Area Index) score, 25 points as mild, moderate, and severe); 4. Receive RTX treatment for the first time; 5. Sign the informed consent; 6. Can receive treatment and follow-up as planned;

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
complete remission.;Complete remission off therapy;

Secondary

MeasureTime frame
Cumulative glucocorticoid dosage;

Countries

China

Contacts

Public ContactZhang Furen

Shandong Provincial Hospital for Skin Diseases & Shandong First Medical University

frzhang@sdfmu.edu.cn+86 187 6671 9565

Outcome results

None listed

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