Dermatology DiseaseEtude PRERINCT06903494
Assessment of the 1-year Relapse Rate in Patients with Pemphigus Treated According to the Revised Pemphigus PNDS
An observational study of Dermatology Disease, run by University Hospital, Rouen at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dermatology Disease
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 17 Feb 2021to 1 Mar 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients with newly diagnosed pemphigus treated as 1st-line patients with rituximab according to the recommendations of the revised PNDS,
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the 1-year Relapse Rate in Patients with Pemphigus Treated According to the Revised Pemphigus PNDS (national Diagnosis and Care Protocol)
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.
Read the detailed description
Pemphigus is a rare, potentially life-threatening autoimmune bullous disease affecting both the skin and mucous membranes in which pathogenic IgG antibodies are directed against desmosomal transmembrane desmoglein (Dsg) 1 and 3. The initial severity of lesions in pemphigus correlates with levels of serum anti-Dsg antibodies anti-Dsg 1 and anti-Dsg 3 serum antibody levels, respectively. High doses of oral corticosteroids (OCs), sometimes combined with immunosuppressive drugs (azathioprine, mycophenolate mofetil) have been the mainstay of pemphigus treatment for many years for many years.
Over the last decade, more than 1,000 patients with recalcitrant or relapsing pemphigus have been treated pemphigus treated with rituximab (anti-CD20 monoclonal antibody) have been monoclonal antibody) have been reported in the literature.
The efficacy and safety of rituximab as a first-line treatment for patients with moderate to severe forms of pemphigus were recently evaluated in a large randomised controlled trial. Two predictive factors for early relapse that can be easily used in practice were identified, with a positive predictive value of 50% and a negative predictive value of 94% (initial PDAI severity score >45 and anti-desmoglein 1 >20 IU/ml and/or anti-desmoglein 3 >130 IU/ml at M3 after the first rituximab infusion).
Thus, the probability of an early relapse in patients presenting at least one of these 2 clinico-immunological criteria is 50%, whereas the probability of not relapsing in patients with none of these criteria is 94%.
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
- Medical subject headings
- Pemphigus
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (2)
Evaluation of prognostic factors for short-term relapse (no maintenance infusion at 6 month))
Determining no maintenance infusion at 6 month after after starting treatment by rituximab In patients with no risk factors for relapse .
Measured: 6 month
Prognostic factors for short-term relapse (Tolerability of the treatment regimen proposed in the revised PNDS)
Assessment of severe and non-severe side effects during the 1st year of treatment
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start17 Feb 2021
- Primary completion17 Feb 2024
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatology DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal PJ JOLY, Professor, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06903494
- Sponsor's protocol ID
- 2020/144/OB
- Other IDs
- 2020-A01312-37
- Acronym
- Etude PRERI
- Status last verified
- Mar 2024
- First submitted
- 24 Mar 2025
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data provided will be the property of the sponsor and will be used solely for its own research activities.
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the 1-year Relapse Rate in Patients with Pemphigus Treated According to the Revised Pemphigus PNDS (national Diagnosis and Care Protocol)
- ClinicalTrials.gov ID
- NCT06903494
- Acronym / sponsor ID
- Etude PRERI / 2020/144/OB
- Conditions
- Dermatology Disease
- Keywords
- pemphigus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 17 Feb 2021 (actual)
- Primary completion
- 17 Feb 2024 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 30 Mar 2025 (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.
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.
Detailed description
Pemphigus is a rare, potentially life-threatening autoimmune bullous disease affecting both the skin and mucous membranes in which pathogenic IgG antibodies are directed against desmosomal transmembrane desmoglein (Dsg) 1 and 3. The initial severity of lesions in pemphigus correlates with levels of serum anti-Dsg antibodies anti-Dsg 1 and anti-Dsg 3 serum antibody levels, respectively. High doses of oral corticosteroids (OCs), sometimes combined with immunosuppressive drugs (azathioprine, mycophenolate mofetil) have been the mainstay of pemphigus treatment for many years for many years.
Over the last decade, more than 1,000 patients with recalcitrant or relapsing pemphigus have been treated pemphigus treated with rituximab (anti-CD20 monoclonal antibody) have been monoclonal antibody) have been reported in the literature.
The efficacy and safety of rituximab as a first-line treatment for patients with moderate to severe forms of pemphigus were recently evaluated in a large randomised controlled trial. Two predictive factors for early relapse that can be easily used in practice were identified, with a positive predictive value of 50% and a negative predictive value of 94% (initial PDAI severity score >45 and anti-desmoglein 1 >20 IU/ml and/or anti-desmoglein 3 >130 IU/ml at M3 after the first rituximab infusion).
Thus, the probability of an early relapse in patients presenting at least one of these 2 clinico-immunological criteria is 50%, whereas the probability of not relapsing in patients with none of these criteria is 94%.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients with newly diagnosed pemphigus treated as 1st-line patients with rituximab according to the recommendations of the revised PNDS,
Key inclusion criteria (7 listed)
- Pemphigus newly diagnosed according to the following criteria:
- 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
Key exclusion criteria (4 listed)
- 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
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
Relapse rate over one year
Time frame: 1 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.
2 secondary outcomes
Evaluation of prognostic factors for short-term relapse (no maintenance infusion at 6 month))
Time frame: 6 month
Prognostic factors for short-term relapse (Tolerability of the treatment regimen proposed in the revised PNDS)
Time frame: 1 year
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 30 Mar 2025.
- Individual participant dataSharing planned: No. The data provided will be the property of the sponsor and will be used solely for its own research activities.
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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.
Pascal PJ JOLY, Professor principal investigator
University Hospital, Rouen
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 Dermatology Disease, run by University Hospital, Rouen at 1 site in France.
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 7 inclusion and 4 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 30 Mar 2025. 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 France. 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?
Relapse rate over one year (time frame: 1 year). 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 30 Mar 2025.