NCT06654817

Efficacy and Safety Evaluation of Anti-CD20 Monoclonal Antibody Combined with Azathioprine and Corticosteroids in the Treatment of Pemphigus Vulgaris

Evaluation of Combination Therapy with Ofatumumab and Systemic Corticosteroids for Pemphigus: a Multi-center Cohort Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 38 (actual)
• Sponsor: Chao Ji · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A prospective cohort study was conducted, following patients for 36 weeks from January 1, 2023, to April 30, 2024. Patients meeting the diagnostic criteria were nonrandomly grouped based on screening results. The primary endpoints were time to disease control and skin healing. Secondary endpoints included complete remission rates, relapse rates, corticosteroid doses, pemphigus disease area index (PDAI), dermatology life quality index (DLQI), visual analogue scale (VAS) pain scores, CD19+ B cell percentages, desmoglein-specific antibodies, and adverse events.

Conditions

• Pemphigus
• Pemphigus Vulgaris (PV)

Interventions

Type	Name	Description
DRUG	Ofatumumab subcutaneous injection	To compare the efficacy and safety of two treatment strategies: ofatumumab combined with corticosteroids versus corticosteroids along with azathioprine, in pemphigus patients.

Timeline

• Start date: 2023-01-01
• Primary completion: 2024-04-01
• Completion: 2024-04-01
• First posted: 2024-10-23
• Last updated: 2024-10-23

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study