CompletedNot Applicable

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

China38 participantsStarted 2023-01-01

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: \- Patients with moderate to severe pemphigus who have poor control of previous external medications and require systemic treatment have a PDAI (Pemphigus Area and Activity Score) greater than 9 points. Exclusion Criteria: * Patients with serious basic diseases, with hepatitis B and three positive cases, and with a history of immunoglobulin related diseases.

What they're measuring

Pemphigus Disease Area Index (PDAI）

Timeframe: 36 week

Trial details

NCT IDNCT06654817

SponsorChao Ji

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-04-01

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