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Completed

NCT Number: NCT07457944

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

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

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Dermatology, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • follow-up for at least 6 months after initiation of rituximab therapy

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. relapse

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

    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

  2. disease control

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

    according to Pemphigus S2 Guideline, patients' new lesions cease to form and established lesions begin to heal

  3. adverse evert

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

Secondary outcomes

  1. dose of glucocorticoids

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

    According to the clinical glucocorticoid dosage record

  2. immunoglobulin levels

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

  3. Concomitant medication

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

    According to the clinical medication record

  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

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Collaborators

  • Chinese Academy of Medical Sciences
  • Guangdong Provincial Dermatology Hospital
  • Peking University First Hospital
  • Second Xiangya Hospital of Central South University
  • West China Hospital

Registry information

Official study title

Efficacy and Safety of Different Doses of Rituximab Therapy in Pemphigus Patients--a Multicenter Retrospective Study

Important dates

Study start
2019
Primary completion
2023
Study completion
2026
First posted
Mar 9, 2026
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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