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ACTIVE NOT RECRUITING
NCT04400994
PHASE2

IVIG With Rituximab vs Rituximab as First Line Treatment of Pemphigus

Sponsor: The University of Hong Kong

View on ClinicalTrials.gov

Summary

Pemphigus is a rare acquired autoimmune disease in which immunoglobulin G (IgG) antibodies target desmosomal proteins to produce intraepithelial, and mucocutaneous blisters. It is potentially fatal and the average mortality of pemphigus vulgaris (PV) was 75% before the introduction of corticosteroids in the early 1950s. Traditionally, treatment of pemphigus included high dose systemic corticosteroids with or without adjuvant immunosuppressants. However; the prolonged use of high dose steroids carries significant side effects. A recent randomized trial has proved the efficacy of Rituximab, a monoclonal anti-CD20 antibody against B-lymphocytes, as an efficacious therapy for pemphigus. Early use of rituximab was associated with better clinical outcomes, hence combination treatment of rituximab and intravenous immunoglobulins (IVIG) has shown to be effective for refractory pemphigus cases and can potentially induce long-term complete remission and lower risks infectious complications. In this study, investigators will evaluate the efficacy and safety of early use of rituximab with or without IVIG in patients with moderate to severe pemphigus using protocols that were similar to those previously published, investigators will also aim to measure the impact of health care economics and in doing so, assess the cost and benefits of both treatment arms.

Official title: The Use of IVIG in Combination With Rituximab VS Rituximab as the First Line Treatment of Pemphigus

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2020-06-20

Completion Date

2026-06-30

Last Updated

2025-07-08

Healthy Volunteers

No

Conditions

Interventions

DRUG

Rituximab

Rituximab would be given intravenously. * IV Rituximab is prediluted at a dose of 500mg in 500ml of 0.9% normal saline (i.e. 1:1 dilution, 1 mg/ml) * Initial infusion rate starts at a rate of 50mg/hr (50ml/hr) * If no hypersensitivity/anaphylaxis reaction occurs, increase infusion rate in 50mg/hr (50 ml/hr) increments every 30 minutes * Maximum infusion rate is 400 mg/hr (400 ml/hr) * Subsequent infusion: start at rate of 100mg/hr (100 ml/hr), increase 100mg/hr (100 ml/hr) increments every 30 minutes * Monitor temperature, BP HR, respiratory rate and SpO2 every 30 minutes

OTHER

IVIg

IVIg would be given in combination with Rituximab intravenously. Infusion plan of IVIg: 0 min: 50ml/hour 15 min: 75ml/hour 30 min: 100ml/hour 45 min: 125ml/hour 60 min: 150ml/hour 75 min \& beyond: 180ml/hour

Locations (1)

Department of Medicine

Central, Hong Kong