Pemphigus VulgarisNCT06167408
Identifying Factors Influencing In-Hospital Relapse in Pemphigus Patients
An observational study of Pemphigus Vulgaris, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Pemphigus Vulgaris
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 1 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- inpatients.
- Pathologic diagnosis of pemphigus.
Who cannot join
- Patients hospitalized for cyclophosphamide shock therapy only.
- Patients who did not recover and were discharged due to personal reasons.
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated hospital of Chongqing Medical University
Chongqing, Yuzhong District, 400000
About this study
Official title: Identifying Factors Influencing In-Hospital Relapse in Pemphigus Patients: A Retrospective Study
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.
Read the detailed 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.
- Conditions
- Pemphigus Vulgaris
- Medical subject headings
- Pemphigus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pemphigus patients in the First Affiliated Hospital of Chongqing Medical University | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
in-hospitalization relapse
the occurrence of in-hospital relapse among pemphigus patients during acute episodes
Measured: through hospitalization (Up to 1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start1 Jan 2022
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pemphigus VulgarisStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Chongqing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanyi Wu, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06167408
- Sponsor's protocol ID
- 20231130
- Status last verified
- Dec 2023
- First submitted
- 30 Nov 2023
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Factors Influencing In-Hospital Relapse in Pemphigus Patients: A Retrospective Study
- ClinicalTrials.gov ID
- NCT06167408
- Acronym / sponsor ID
- 20231130
- Conditions
- Pemphigus Vulgaris
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 12 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pemphigus patients in the First Affiliated Hospital of Chongqing Medical University | – | – |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- inpatients.
- Pathologic diagnosis of pemphigus.
Key exclusion criteria (2 listed)
- Patients hospitalized for cyclophosphamide shock therapy only.
- Patients who did not recover and were discharged due to personal reasons.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
in-hospitalization relapse
Time frame: through hospitalization (Up to 1 month)
the occurrence of in-hospital relapse among pemphigus patients during acute episodes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Pemphigus Vulgaris
RecruitingPhase 1/2
A Phase 1/2, Open-label, Safety and Dosing Study of Autologous CART Cells (Desmoglein 3 Chimeric Autoantibody Receptor T Cells [DSG3-CAART] or CD19-specific Chimeric Antigen Receptor T Cells [CABA-201]) in Subjects With Active, Pemphigus Vulgaris (RESET-PV)
Pemphigus Vulgaris
Not yet recruitingEarly Phase 1
Rituximab With Corticosteroids Versus Corticosteroids Plus Azathioprine for Moderate-to-Severe Pemphigus Vulgaris
Pemphigus Vulgaris, Rituximab (RTx)
Recruiting
CD19 CAR-T Therapy for Refractory Pemphigus Vulgaris
Pemphigus Vulgaris
Recruiting
Comparison of the Efficacy of Clobetasol Propionate 0.05% Mouthwash, Photobiomodulation, and Their Combination in Managing of Oral Lesions in Patient With Pemphigus Vulgaris.
Oral Lesions in Patients With Pemphigus Vulgaris
RecruitingObservational study
Autoimmune Blistering Diseases Study
Pemphigus Vulgaris, Pemphigus Foliaceus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pemphigus Vulgaris, run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
in-hospitalization relapse (time frame: through hospitalization (Up to 1 month)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2023.