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

NCT07769333 | Not Yet Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: 343/IREB/KTH
• Study Type: interventional
• Target: 92
• Locations: 0 countries
• Sites: N/A

Brief 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)

Outcome Measures

Primary Outcomes (1)

• PDAI SCORE

  PDAI score will be assessed to measure disease activity in patients with pemphigus vulgaris. The PDAI score ranges from 0 to 250. Higher scores indicate more severe disease activity and a worse outcome.

  Baseline, 2 weeks, 1 month, 3 months, and 6 months after baseline

Study Arms (2)

RITUXIMAB

EXPERIMENTAL

Drug: Rituxan (rituximab)

CORTICOSTEROIDS PLUS AZATHIOPRINE

ACTIVE COMPARATOR

Drug: Azathioprine (AZA)' plus corticosteroids

Interventions

Rituxan (rituximab) DRUG

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

RITUXIMAB

Azathioprine (AZA)' plus corticosteroids DRUG

A CONVRNTIONAL TREATMENT FOR P.V

CORTICOSTEROIDS PLUS AZATHIOPRINE

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18-65 years.
• Active moderate-to-severe pemphigus vulgaris.
• Newly diagnosed disease or disease flare.
• Diagnosis confirmed by biopsy and direct immunofluorescence

You may not qualify if:

• Mild pemphigus vulgaris.
• Pregnancy or lactation.
• Active malignancy.
• Serious infection.
• Severe cardiac disease.
• Severe renal disease.
• Severe hepatic disease.
• Prior exposure to rituximab within the last 12 months.

Sponsors & Collaborators

• Khyber Teaching Hospital: lead

Related Publications (4)

• Szymanski K, Kowalewski C, Walecka I, Wozniak K. Eight Years of Follow-Up of Rituximab in Pemphigus Vulgaris and Foliaceus at a Single Center: Assessing Efficacy and Safety in Light of Several Factors. J Clin Med. 2025 Oct 16;14(20):7318. doi: 10.3390/jcm14207318.

  PMID: 41156189 RESULT

• Cao S, Yang B, Wang Z, Liu T, Sun Y, Zhang Z, Pan F, Yang Q, Geng H, Zhao Q, Liu H, Zhang F. Efficacy, safety, and B-cell depletion capacity of 3 rituximab dosing regimens in the treatment of moderate-to-severe pemphigus vulgaris and pemphigus foliaceus: A 52-week clinical trial. J Am Acad Dermatol. 2025 Sep;93(3):634-643. doi: 10.1016/j.jaad.2025.05.1374. Epub 2025 May 13.

  PMID: 40374120 RESULT

• Liu SH, Wang SH, Zuo YG. Efficacy and safety of low dose rituximab in pemphigus: an updated systematic review and meta-analysis. Front Immunol. 2025 Jul 25;16:1605243. doi: 10.3389/fimmu.2025.1605243. eCollection 2025.

  PMID: 40787442 RESULT

• Branisteanu DE, Lotti T, Colac Botoc C, Hutanu AE, Munteanu CA, Ciobanu RP, Branisteanu DC, Colac AG, Branisteanu CIO, Branisteanu G, Toader SV, Toader MP. Real-world outcomes with rituximab vs. conventional therapy in pemphigus vulgaris: a single-center Romanian cohort. Front Med (Lausanne). 2025 Nov 12;12:1691897. doi: 10.3389/fmed.2025.1691897. eCollection 2025.

  PMID: 41312452 RESULT

MeSH Terms

Conditions

Pemphigus

Interventions

Rituximab; Azathioprine; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Skin Diseases, Vesiculobullous; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Thionucleosides; Sulfur Compounds; Organic Chemicals; Mercaptopurine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

NOOR AYAZ, MBBS

CONTACT

+923345536315; drnoorayaz@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DR

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: August 17, 2026
• Study Start (Estimated): December 2, 2026
• Primary Completion (Estimated): May 5, 2027
• Study Completion (Estimated): November 6, 2027
• Last Updated: August 18, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share