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Rituximab With Corticosteroids Versus Corticosteroids Plus Azathioprine for Moderate-to-Severe Pemphigus Vulgaris

NCT07769333 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2026-08-18

No results posted yet for this study

Summary

This quasi-experimental study aims to compare the effectiveness and safety of rituximab combined with corticosteroids versus the standard regimen of oral corticosteroids plus azathioprine in patients with moderate to severe pemphigus vulgaris.

Pemphigus vulgaris is a rare autoimmune blistering disease. Conventional treatment with high-dose corticosteroids and azathioprine, though effective, is associated with significant long-term side effects. Rituximab, a B-cell depleting monoclonal antibody, has emerged as a promising alternative that may achieve higher rates of complete remission, faster disease control, fewer relapses, and reduced cumulative steroid exposure.

Patients will be allocated non-randomly into two groups based on clinical suitability, affordability, and preference. Outcomes will be assessed over 12 months, focusing primarily on complete remission rates, with secondary evaluation of time to disease control, relapse rates, cumulative corticosteroid dose, and adverse events.

The study seeks to generate local evidence from Pakistan to guide more effective and safer treatment protocols for moderate to severe pemphigus vulgaris.

Conditions

  • Pemphigus Vulgaris
  • Rituximab (RTx)

Interventions

DRUG

Rituxan (rituximab)

a biological drug plus corticosteroids in the treatment of P.V

DRUG

Azathioprine (AZA)' plus corticosteroids

A CONVRNTIONAL TREATMENT FOR P.V

Sponsors & Collaborators

  • Khyber Teaching Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2026-12-02
Primary Completion
2027-05-05
Completion
2027-11-06
FDA Drug
Yes

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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 NCT07769333 on ClinicalTrials.gov