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Efficacy and safety of ultra-low dosage regimen of rituximab combined with corticosteroids in the treatment of pemphigus

Efficacy and safety of ultra-low dosage regimen of rituximab combined with corticosteroids in the treatment of pemphigus

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800020382
Enrollment
Unknown
Registered
2018-12-27
Start date
2019-01-01
Completion date
Unknown
Last updated
2019-01-14

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

Conditions

Pemphigus

Interventions

Group 1:Rituximab 500mg single infusion combined with routinedose of corticosteriods therapy
Group 2:Rituximab 100mg single infusion combined with routinedose of corticosteriods therapy
Group 3:Oral or intravenous infusion of routinedose of corticosteriods (prednisone or methylprednisolone)

Sponsors

West China Hospital, Sichuna University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients who meet the diagnostic criteria for pemphigus, especially those with long-term oral administration of corticosteriods or immunosuppressive agents; Clinical manifestations: (1) multiple looseness on the skin, easy to rupture bullae; (2) refractory erosion surface secondary to blisters, scales or scars; (3) non-infectious blisters or erosions in the mucosal area (including the oral mucosa); (4) Nikolsky sign positive: 1) Histopathology: acanthosis; blister formation between epidermal cells; 2) Immunodiagnostic indicators: normal skin direct immunofluorescence (DIF) around the lesion area or lesions indicates IgG and/or complement deposition between epidermal cells; indirect immunofluorescence (IIF) detects anti-cell interphase in serum Anti-Dsg antibodies were detected in the serum by antibodies or ELISA. 2. Aged 18 to 80 years old; 3. Informed consent has been signed; 4. Women of childbearing age who have no birth plan.

Exclusion criteria

Exclusion criteria: (1) Pregnant or lactating women; (2) Women of childbearing age who have a birth plan; (3) Those who are allergic to the drug; (4) Patients with active hepatitis virus replication; (5) HIV-positive patients; patients with potential tuberculosis infection; (6) Combined with other diseases such as tumors, obvious systemic infections, arrhythmia, angina pectoris, cardiac insufficiency, etc.

Design outcomes

Primary

MeasureTime frame
Partial remission rate;Complete remission rate;

Secondary

MeasureTime frame
Desmosin antibody 1;Desmosin antibody 3;B cell count;Pemphigus Disease Area Index;

Countries

China

Contacts

Public ContactLi Wei

West China hospital, Sichuan University

724564806@qq.com+86 18980601695

Outcome results

None listed

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