Efficacy and Safety of Different Doses of Rituximab Therapy in Pemphigus Patients
1 other identifier
observational
275
1 country
1
Brief Summary
Investigating the clinical efficacy of different doses of rituximab in patients with pemphigus
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2026
CompletedFirst Submitted
Initial submission to the registry
March 3, 2026
CompletedFirst Posted
Study publicly available on registry
March 9, 2026
CompletedMarch 9, 2026
March 1, 2026
4 years
March 3, 2026
March 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
week 4, 8, 12, 24, 36, 48 after treatment
disease control
according to Pemphigus S2 Guideline, patients' new lesions cease to form and established lesions begin to heal
week 4, 8, 12, 24, 36, 48 after treatment
adverse evert
week 4, 8, 12, 24, 36, 48 after treatment
Secondary Outcomes (5)
dose of glucocorticoids
week 4, 8, 12, 24, 36, 48 after treatment
immunoglobulin levels
week 4, 8, 12, 24, 36, 48 after treatment
Concomitant medication
week 4, 8, 12, 24, 36, 48 after treatment
serum anti-Dsg1 and Dsg3 autoantibody levels
week 4, 8, 12, 24, 36, 48 after treatment
peripheral CD19+ cell counts
week 4, 8, 12, 24, 36, 48 after treatment
Study Arms (3)
Group A
one dose of 500mg RTX
Group B
two doses of 500mg RTX
Group C
two doses of 1000mg RTX
Eligibility Criteria
Patients who had a clinical presentation of active pemphigus combined with immunological or pathological evidence, and received rituximab
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Guangdong Provincial Dermatology Hospitalcollaborator
- Ruijin Hospitallead
- Peking University First Hospitalcollaborator
- Chinese Academy of Medical Sciencescollaborator
- West China Hospitalcollaborator
- Second Xiangya Hospital of Central South Universitycollaborator
Study Sites (1)
Department of Dermatology, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2026
First Posted
March 9, 2026
Study Start
January 1, 2019
Primary Completion
January 1, 2023
Study Completion
January 1, 2026
Last Updated
March 9, 2026
Record last verified: 2026-03