NCT06167408

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 12, 2023

Completed
Last Updated

December 12, 2023

Status Verified

December 1, 2023

Enrollment Period

5 months

First QC Date

November 30, 2023

Last Update Submit

December 10, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • in-hospitalization relapse

    the occurrence of in-hospital relapse among pemphigus patients during acute episodes

    through hospitalization (Up to 1 month)

Study Arms (1)

Pemphigus patients in the First Affiliated Hospital of Chongqing Medical University

Eligibility Criteria

AgeUp to 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study included 96 patients diagnosed with pemphigus who received inpatient treatment at the First Affiliated Hospital of Chongqing Medical University between January 1st, 2014, and December 31st, 2020. The inclusion criteria covered both initial and follow-up cases, without age or sex restrictions. Diagnosis was confirmed through pathological biopsy, classifying pemphigus into different types. Patients underwent routine assessments, received various treatments, and were monitored for complications during hospitalization. Ten patients with multiple hospitalizations for cyclophosphamide pulse therapy and three patients not recovering were excluded.

You may qualify if:

  • inpatients.
  • Pathologic diagnosis of pemphigus.

You may not qualify if:

  • Patients hospitalized for cyclophosphamide shock therapy only.
  • Patients who did not recover and were discharged due to personal reasons.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated hospital of Chongqing Medical University

Chongqing, Yuzhong District, 400000, China

Location

MeSH Terms

Conditions

Pemphigus

Condition Hierarchy (Ancestors)

Skin Diseases, VesiculobullousSkin DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

November 30, 2023

First Posted

December 12, 2023

Study Start

January 1, 2022

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

December 12, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations