Assessment of the 1-year Relapse Rate in Patients with Pemphigus Treated According to the Revised Pemphigus PNDS

NCT06903494 | Completed

• 2 other identifiers: 2020/144/OB2020-A01312-37
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

In May 2018, the PNDS (national diagnosis and care protocol) for pemphigus drawn up by the autoimmune bullous diseases reference centre was amended to take into account the results of recent studies and proposed, in line with the rituximab as 1st-line treatment: 1g repeated at 15-day intervals, then in the event of complete clinical remission, at 6 months: an infusion of 500mg or 1g in patients with initially severe pemphigus and/or who still have a high level of anti desmogleins at 3 months. The primary objective of the study is to prospectively evaluate the relapse rate during the first year of patients with newly diagnosed pemphigus treated according to the recommendations of the revised PNDS.

Conditions

Dermatology Disease

Keywords

pemphigus

Outcome Measures

Primary Outcomes (1)

• Relapse rate over one year

  The primary objective of the study was to prospectively evaluate the relapse rate during the first year of patients with newly diagnosed pemphigus treated according to the recommendations of the revised PNDS. Relapse' is defined as 'the reappearance of at least three new lesions per month, which do not heal spontaneously within one week or by the extension of old lesions in a patient who had previously achieved disease control.

  1 year

Secondary Outcomes (2)

• Evaluation of prognostic factors for short-term relapse (no maintenance infusion at 6 month))

  6 month

• Prognostic factors for short-term relapse (Tolerability of the treatment regimen proposed in the revised PNDS)

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consecutive patients with newly diagnosed pemphigus treated as 1st-line patients with rituximab according to the recommendations of the revised PNDS,

You may qualify if:

• Pemphigus newly diagnosed according to the following criteria:
• erosions and/or superficial cutaneous and/or mucosal bullae, suggestive of pemphigus vulgaris (PV) or pemphigus superficialis (PS)
• histological appearance of intraepidermal acantholysis
• IgG and/or C3 deposits on the keratinocyte membrane (after meshwork)
• Patient who has been informed
• Moderate to severe pemphigus (PDAI score \> 15), or mild pemphigus (PDAI score ≤ 15) that has not responded to the 1st line of treatment recommended in the NDSP (local corticosteroid therapy ± disulone) after three months.
• Patient who has agreed to be monitored and treated according to the revised PNDS

You may not qualify if:

• Patient âgé de moins de 18 ans
• Diagnostic de Pemphigus (PV) ou (PS) restant incertain
• Pemphigus paranéoplasique
• Malade opposé à sa participation ou ne pouvant être suivi régulièrement

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

Pascal

Rouen, 76031, France

Location

MeSH Terms

Conditions

Pemphigus

Condition Hierarchy (Ancestors)

Skin Diseases, Vesiculobullous; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Pascal PJ JOLY, Professor

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: March 30, 2025
• Study Start: February 17, 2021
• Primary Completion: February 17, 2024
• Study Completion: March 1, 2025
• Last Updated: March 30, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)