An Early Phase 1 interventional study of Rituxan (rituximab) and Azathioprine (AZA)' plus corticosteroids in Pemphigus Vulgaris and Rituximab (RTx), sponsored by Khyber Teaching Hospital. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by Khyber Teaching Hospital · Early Phase 1, Interventional, and Treatment
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.
Pemphigus vulgaris is a rare but serious autoimmune disease in which the body's immune system produces antibodies that attack proteins (desmogleins) responsible for holding skin and mucosal cells together. This leads to painful blisters and erosions on the skin and mucous membranes, particularly in the mouth. If not treated effectively, the condition can cause significant morbidity and, in severe cases, life-threatening complications.
For many years the standard approach has involved high-dose oral corticosteroids combined with an immunosuppressive agent such as azathioprine. While this combination can control the disease, prolonged use of corticosteroids frequently results in serious adverse effects, including diabetes, osteoporosis, increased susceptibility to infections, and Cushingoid features. These complications often limit the long-term safety of conventional therapy.
Rituximab is a monoclonal antibody that specifically targets CD20-positive B-cells, the cells responsible for producing the harmful autoantibodies. By depleting these cells, rituximab addresses the underlying immunological mechanism of the disease more selectively than broad immunosuppression. Growing evidence from international studies suggests that rituximab, when used with a short course of corticosteroids, can achieve higher rates of sustained remission, reduce the frequency of relapses, and substantially lower the total amount of corticosteroids patients need to take.
Despite these promising findings, comparative data from Pakistan and similar resource-constrained settings remain limited. Cost, availability, and local clinical experience still influence treatment choices. A quasi-experimental design is therefore appropriate: patients with moderate to severe disease will be assigned to one of two treatment arms according to clinical suitability, affordability, and informed preference rather than by randomisation. One group will receive rituximab plus corticosteroids; the other will receive the conventional regimen of oral corticosteroids plus azathioprine.
Patients will be followed for twelve months. The primary focus will be the proportion of patients who achieve complete clinical remission. Secondary measures will include the time required to achieve disease control, the number and timing of relapses, the cumulative dose of corticosteroids administered, and the frequency and severity of treatment-related adverse events. Disease activity will be monitored using the Pemphigus Disease Area Index (PDAI) at regular intervals.
By generating local comparative data, this study aims to clarify whether rituximab-based therapy offers meaningful advantages in effectiveness and safety over the conventional regimen in the Pakistani population, thereby supporting more informed treatment decisions for patients with moderate to severe pemphigus vulgaris.
76 studies on the registry are indexed under Pemphigus; 18 are open to participants now.
This study's planned enrollment of 92 is above the median of 30 across 53 interventional studies indexed under Pemphigus.
Browse Pemphigus studies →Khyber Teaching Hospital is the lead sponsor of 29 studies on the registry; 19 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Rituxan (rituximab)
Drug: Azathioprine (AZA)' plus corticosteroids
a biological drug plus corticosteroids in the treatment of P.V
A CONVRNTIONAL TREATMENT FOR P.V
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.
Time frame: Baseline, 2 weeks, 1 month, 3 months, and 6 months after baseline
No study locations are listed for this record.
Plan to share: No
Start is estimated for Dec 2026; primary completion for May 2027, 5 months later.
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This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Rituximab
Khyber Teaching Hospital