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

NCT06654817 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 38

Last updated 2024-10-23

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Chao Ji

    lead OTHER

Principal Investigators

  • Zhuang Zheyu Zheyu Zhuang · Chao Ji

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2024-04-01
Completion
2024-04-01
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06654817 on ClinicalTrials.gov