Efficacy and Safety Evaluation of Anti-CD20 Monoclonal Antibody Combined with Azathioprine and Corticosteroids in the Treatment of Pemphigus Vulgaris

October 22, 2024 updated by: Chao Ji

Evaluation of Combination Therapy with Ofatumumab and Systemic Corticosteroids for Pemphigus: a Multi-center Cohort Study

A prospective cohort study was conducted, following patients for 36 weeks from January 1, 2023, to April 30, 2024. Patients meeting the diagnostic criteria were nonrandomly grouped based on screening results. The primary endpoints were time to disease control and skin healing. Secondary endpoints included complete remission rates, relapse rates, corticosteroid doses, pemphigus disease area index (PDAI), dermatology life quality index (DLQI), visual analogue scale (VAS) pain scores, CD19+ B cell percentages, desmoglein-specific antibodies, and adverse events.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

38

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350000
        • First Affiliated Hospital of Fujian Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with alopecia areata

Inclusion Criteria:

Patients with moderate to severe pemphigus who have poor control of previous external medications and require systemic treatment have a PDAI (Pemphigus Area and Activity Score) greater than 9 points.

Exclusion Criteria:

  • Patients with serious basic diseases, with hepatitis B and three positive cases, and with a history of immunoglobulin related diseases.

Description

Inclusion Criteria:

- Patients with moderate to severe pemphigus who have poor control of previous external medications and require systemic treatment have a PDAI (Pemphigus Area and Activity Score) greater than 9 points.

Exclusion Criteria:

  • Patients with serious basic diseases, with hepatitis B and three positive cases, and with a history of immunoglobulin related diseases.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
experimental group

ofatumumab combined with corticosteroids versus corticosteroids

To compare the efficacy and safety of two treatment strategies: ofatumumab combined with corticosteroids versus corticosteroids along with azathioprine, in pemphigus patients.

A prospective cohort study was conducted, following patients for 36 weeks from January 1, 2023, to April 30, 2024. Patients meeting the diagnostic criteria were nonrandomly grouped based on screening results. The primary endpoints were time to disease control and skin healing. Secondary endpoints included complete remission rates, relapse rates, corticosteroid doses, pemphigus disease area index (PDAI), dermatology life quality index (DLQI), visual analogue scale (VAS) pain scores, CD19+ B cell percentages, desmoglein-specific antibodies, and adverse events.
Drug: Ofatumumab subcutaneous injection
To compare the efficacy and safety of two treatment strategies: ofatumumab combined with corticosteroids versus corticosteroids along with azathioprine, in pemphigus patients.
control group
the standard treatment of corticosteroids plus azathioprine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pemphigus Disease Area Index (PDAI）
Time Frame: 36 week
Pemphigus Disease Area Index (PDAI). PDAI activity score cutoffs were defined as 0 to 8 for mild, 9 to 24 for moderate, and 25 or higher for severe disease.
36 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chao Ji

Investigators

  • Study Director: Zhuang Zheyu Zheyu Zhuang, Chao Ji

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Actual)

April 1, 2024

Study Completion (Actual)

April 1, 2024

Study Registration Dates

First Submitted

October 14, 2024

First Submitted That Met QC Criteria

October 22, 2024

First Posted (Actual)

October 23, 2024

Study Record Updates

Last Update Posted (Actual)

October 23, 2024

Last Update Submitted That Met QC Criteria

October 22, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRCTA,ECFAH OfFMU|2024]565

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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