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CompletedNCT07457944Updated Mar 9, 2026

Efficacy and Safety of Different Doses of Rituximab Therapy in Pemphigus Patients

An observational study in Pemphigus Disease and Rituximab (RTx), sponsored by Ruijin Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-03-09.

Sponsored by Ruijin Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
275
Ages
18 Years to 100 Years
Sex
All
01

Study summary

Investigating the clinical efficacy of different doses of rituximab in patients with pemphigus

Read the detailed description

Pemphigus is a severe autoimmune skin disease traditionally treated with systemic corticosteroids and immunosuppressants. Recent studies have highlighted the superior efficacy of rituximab combined with systemic corticosteroids, establishing this combination as a first-line treatment for pemphigus patients.

Currently, the administration protocols for rituximab in pemphigus patients often refer to the dosage used for rheumatoid arthritis: two intravenous infusions of 500 mg or 1000 mg spaced two weeks apart, with an additional 500 mg infusion after 6 to 9 months if necessary. Recently, several studies have reported successful treatment of pemphigus using low-dose (single 500 mg dose) or ultra-low-dose (single 200 mg dose) rituximab.

As an optimal dosage regimen for pemphigus has yet to be established, we conducted a retrospective cohort study to evaluate the efficacy of different rituximab dosages and explore the optimal dosing strategy for the treatment of pemphigus.

02

Conditions studied

  • Pemphigus Disease
  • Rituximab (RTx)

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Keywords

  • Pemphigus
  • Rituximab
  • Adverse effect
03

In context

Pemphigus

76 studies on the registry are indexed under Pemphigus; 18 are open to participants now.

This study's enrollment of 275 is above the median of 60 across 21 observational studies indexed under Pemphigus.

Browse Pemphigus studies →

Lead sponsor

Ruijin Hospital is the lead sponsor of 679 studies on the registry; 387 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

Patients who had a clinical presentation of active pemphigus combined with immunological or pathological evidence, and received rituximab

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.

Inclusion criteria

  1. patients with a diagnosis of pemphigus vulgaris or foliaceus in active stage based on guideline indicators, including typical clinical presentation, positive direct immunofluorescence microscopy findings, and/or detection of serum anti-Dsg3 and/or Dsg1 immunoglobin (Ig)G autoantibodies
  2. follow-up for at least 6 months after initiation of rituximab therapy

Exclusion criteria

Exclusion Criteria:

  1. Previous use of rituximab for other indications
  2. concomitant use of other biological agents within 6 months (e.g. Dupilumab,IL-17,FcRn)
  3. with a diagnosis of other variants of pemphigus besides PV and PF
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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
275 participants (actual)
Patient registry
No

Groups and cohorts

  • Group A

    one dose of 500mg RTX

  • Group B

    two doses of 500mg RTX

  • Group C

    two doses of 1000mg RTX

06

What researchers measure

Primary outcomes

  1. relapse

    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

  2. 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

  3. adverse evert

    Time frame: week 4, 8, 12, 24, 36, 48 after treatment

Secondary outcomes

  1. dose of glucocorticoids

    According to the clinical glucocorticoid dosage record

    Time frame: week 4, 8, 12, 24, 36, 48 after treatment

  2. immunoglobulin levels

    Time frame: week 4, 8, 12, 24, 36, 48 after treatment

  3. Concomitant medication

    According to the clinical medication record

    Time frame: week 4, 8, 12, 24, 36, 48 after treatment

  4. serum anti-Dsg1 and Dsg3 autoantibody levels

    Time frame: week 4, 8, 12, 24, 36, 48 after treatment

  5. peripheral CD19+ cell counts

    Time frame: week 4, 8, 12, 24, 36, 48 after treatment

07

Study locations

1 site
  • Department of Dermatology, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine
    Shanghai, Shanghai Municipality, China
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2019 to primary completion in Jan 2023, 48 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 3, 2026
First posted
Mar 9, 2026
StartActual
Jan 1, 2019
Primary completionActual
Jan 1, 2023
CompletionActual
Jan 1, 2026
Last update
Mar 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07457944
Lead sponsor
Ruijin Hospital
Collaborators
Peking University First Hospital, Guangdong Provincial Dermatology Hospital, Chinese Academy of Medical Sciences, West China Hospital, Second Xiangya Hospital of Central South University
Responsible party
Sponsor
First posted
Mar 9, 2026
Start date
Jan 1, 2019
Primary completion
Jan 1, 2023
Completion
Jan 1, 2026
Last update
Mar 9, 2026
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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