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

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorKhyber Teaching Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Adults aged 18-65 years.

Active moderate-to-severe pemphigus vulgaris.

Newly diagnosed disease or disease flare.

Diagnosis confirmed by biopsy and direct immunofluorescence

Disqualifiers

Mild pemphigus vulgaris.

Pregnancy or lactation.

Active malignancy.

Serious infection.

Trial design

Treatments tested in this trial

  • Rituxan (rituximab)
  • Azathioprine (AZA)' plus corticosteroids

Treatment groups

92 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators