Status:
ACTIVE_NOT_RECRUITING
A Single Cycle of Intravenous Immunoglobulin as Adjuvant to Rituximab in Patients With Pemphigus: A Retrospective Cohort Study at a Tertiary Referral Center
Lead Sponsor:
Ruijin Hospital
Conditions:
Pemphigus Disease
Rituximab (RTx)
Eligibility:
All Genders
18-100 years
Brief Summary
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 immuno...
Eligibility Criteria
Inclusion
- Patients' files between January 1st, 2019, and December 31st, 2024 from department of dermatology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
- 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
- treated with RTX in association with oral corticosteroids
- with a follow-up of at least 48 weeks after RTX treatment initiation
Exclusion
- with a diagnosis of other variants of pemphigus (e.g., paraneoplastic pemphigus, herpetiform pemphigus, IgA pemphigus);
- concomitant use of other immunosuppressants (e.g., azathioprine, mycophenolate mofetil, methotrexate)
- previous administration with IVIg for other indications within 12 weeks
Key Trial Info
Start Date :
December 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 2 2026
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT06949241
Start Date
December 1 2019
End Date
February 2 2026
Last Update
April 29 2025
Active Locations (1)
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1
Department of Dermatology, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China