An observational study in Pemphigus Disease, Rituximab (RTx) and Intravenous Immunoglobulin, sponsored by Ruijin Hospital. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-04-29.
Sponsored by Ruijin Hospital · Observational
Pemphigus is a critical autoimmune skin condition mediated by pathogenic autoantibodies mainly against desmoglein (Dsg)1 and Dsg3, and is traditionally managed with systemic corticosteroids and immunosuppressants.The revolutionary introduction of rituximab (RTX) has opened up a new era of pemphigus treatment by enabling treatment strategies to specifically target CD20+ B cells.Studies have highlighted the superior efficacy of RTX combined with systemic corticosteroids, making this therapy first-line treatment for pemphigus patients.Currently, the main challenge for pemphigus management is to maximize efficacy while preventing relapses and reducing risks over the course of the disease.
RTX achieves maximum effect typically at 4-8 weeks post-treatment, and is associated with an elevated risk of infection.On the other hand, intravenous immunoglobulin (IVIg), historically employed for the management of refractory pemphigus, is appreciated for its rapid action and lack of added immunosuppressive risk.It has also been shown to induce long-term clinical remission, and continues to serve as a rescue therapy for difficult cases.
While there have been reports on the successful use of RTX and concomitant IVIg for treating refractory pemphigus, there is a lack of extensive research weighing the pros and cons of adding IVIg to the currently recommended RTX regimen (Rheumatoid arthritis protocol, RAP). To investigate the efficacy and safety of this combined therapy, we conducted an retrospective cohort study to evaluate the impact of incorporating IVIg into the RTX and systemic corticosteroid treatment protocol for pemphigus patients.
76 studies on the registry are indexed under Pemphigus; 18 are open to participants now.
This study's enrollment of 76 is above the median of 60 across 21 observational studies indexed under Pemphigus.
Browse Pemphigus studies →Ruijin Hospital is the lead sponsor of 679 studies on the registry; 387 are open to participants now.
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Patients who had a clinical presentation of active pemphigus combined with immunological or pathological evidence, and received rituximab and systemic corticosteroids.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult patients receiving rituximab and systemic corticosteroids without adjuvant IVIg
Adult patients receiving rituximab and systemic corticosteroids with adjuvant IVIg
numbers of patients under disease control
according to Pemphigus S2 Guideline, patients' new lesions cease to form and established lesions begin to heal
Time frame: week 4, 8, 12, 24, 36, 48 after treatment
Number of patients with relapses
according to Pemphigus S2 Guideline，patient who has achieved disease control appears ≥3 new lesions/month that do not heal spontaneously within 1 week, or patient's established lesions extend
Time frame: week 4, 8, 12, 24, 36, 48 after treatment
Adverse event
Time frame: week 4, 8, 12, 24, 36, 48 after treatment
peripheral CD19+ cell counts
Time frame: week 4, 8, 12, 24, 36, 48 after treatment
Serum rituximab concentration
Time frame: week 4, 8, 12, 24, 36, 48 after treatment
immunoglobulin levels
Time frame: week 4, 8, 12, 24, 36, 48 after treatment
serum anti-Dsg1 and Dsg3 autoantibody levels
Time frame: week 4, 8, 12, 24, 36, 48 after treatment
Serum anti-rituximab antibody concentration
Time frame: week 4, 8, 12, 24, 36, 48 after treatment
This study is active, not recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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