Identifying Factors Influencing In-Hospital Relapse in Pemphigus Patients

Pemphigus Vulgaris Clinical Trial

Official title:

Identifying Factors Influencing In-Hospital Relapse in Pemphigus Patients: A Retrospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06167408
• Other study ID #: 20231130
• Status: Completed
• Start date: January 1, 2022
• Est. completion date: June 1, 2022

Study information

• Verified date: December 2023
• Source: First Affiliated Hospital of Chongqing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objective of this retrospective study was to investigate the factors influencing in-hospital relapse during acute episodes of pemphigus, an autoimmune blistering disease characterized by self-antibodies targeting desmogleins. The study included 96 pemphigus patients hospitalized in China between January 2014 and December 2020. The primary questions addressed by the study were:

What are the risk factors associated with in-hospital relapse during acute episodes of pemphigus? Participants in the study underwent a retrospective analysis using univariate and multivariate Cox regression analysis to identify and understand the various risk factors contributing to in-hospital relapse. This research aimed to contribute valuable insights into the factors influencing the course of pemphigus, providing crucial information for better management and treatment strategies.

Description:

This retrospective study conducted in China between January 2014 and December 2020 aimed to comprehensively examine factors influencing in-hospital relapse during acute episodes of pemphigus, an autoimmune blistering disease characterized by self-antibodies targeting desmogleins-essential cell adhesion molecules. The study enrolled 96 pemphigus patients who were hospitalized during acute episodes.

Research Questions:

Primary Question:

What are the identifiable risk factors associated with in-hospital relapse in pemphigus patients during acute episodes?

Methods:

Study Type: Retrospective Observational Study Participant Population: 96 pemphigus patients hospitalized in China Duration: January 2014 to December 2020

Main Tasks:

Data Collection:

Retrospective analysis of medical records and clinical data of pemphigus patients during acute hospitalizations.

Identification of demographic information, clinical characteristics, and treatment modalities.

Risk Factor Determination:

Univariate and multivariate Cox regression analysis employed to assess potential risk factors.

Variables considered included demographic factors, disease severity, and specific treatment regimens.

Outcome Measurement:

Identification of in-hospital relapse as the primary outcome. Correlation of relapse occurrence with the identified risk factors.

Results:

Key Findings:

Identification of specific risk factors contributing to in-hospital relapse in pemphigus patients.

Quantification of the impact of demographic and clinical variables on relapse probability.

Significance:

Clinical Implications:

Contribution of valuable insights for clinicians in predicting and managing in-hospital relapse in pemphigus patients.

Informing treatment strategies based on identified risk factors.

Research Contribution:

Expansion of understanding regarding the course and management of pemphigus. Providing a foundation for future prospective studies and the development of targeted interventions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 80 Years

Eligibility

Inclusion Criteria:

• inpatients.

• Pathologic diagnosis of pemphigus.

Exclusion Criteria:

• Patients hospitalized for cyclophosphamide shock therapy only.

• Patients who did not recover and were discharged due to personal reasons.

Related Conditions & MeSH terms

• Pemphigus
• Pemphigus Vulgaris

Locations

Country	Name	City	State
China	First Affiliated hospital of Chongqing Medical University	Chongqing	Yuzhong District

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	in-hospitalization relapse	the occurrence of in-hospital relapse among pemphigus patients during acute episodes	through hospitalization (Up to 1 month)