Pemphigus VulgarisCaReLyBPNCT04117529
Phenotypic and Functional Characterisation of Human B-cell Response in Pemphigus
A study testing Blood sample in people with Pemphigus Vulgaris and Pemphigus Foliaceus, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Pemphigus is a rare autoimmune disease involving skin and mucous membranes characterized by the production of pathogenic autoantibodies directed against desmosomal transmembrane glycoproteins belonging to the cadherin family,responsible for the disruption of desmosomes leading to the acantholysis phenomenon.Two main… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pemphigus Vulgaris, Pemphigus Foliaceus
- What is being tested?
- Blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 22 Oct 2019to Jul 2022
- Phase
- Interventional
- 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
Who may be able to join
- Patients man or woman
- Patients above 18 years old
- Patients fulfilling the diagnostic criteria for pemphigus (Lever et al, 1979), or for lupus (SLICC 2012), or for rheumatoid arthritis (ACR / EULAR 2009 criteria), or for Gougerot-Sjögren's syndrome (ACR criteria / EULAR 2016)
- Clinically active disease, defined by the presence of erosions or cutaneo-mucous bubbles for pemphigus, a SLEDAI score> 0 for lupus, a DAS28> 0 score for rheumatoid arthritis, and an EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score> 0 for Gougerot-Sjögren's syndrome
- Patients consenting to participate in the study
- Patients benefiting from the national healthcare insurance
Who cannot join
- Pregnant or lactating woman
- Patient already treated with biotherapy
- Patient already receiving treatment that may affect lymphocyte B populations: corticosteroid therapy> 10 mg / d or other immunosuppressant.
- Patient whose weight and / or hemoglobin level does not allow an additional blood sample during the assessment already provided by the treatment (according to the values in Appendix 2 of the Decree of April 12, 2018, which lists the research mentioned in 2 ° of Article L. 1121-1 of the Public Health Code)
- Person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Pr Philippe MUSETTE - Hôpital AVICENNE
Bobigny, 93000
About this study
Official title: Phenotypic and Functional Characterisation of Human B-cell Response in Pemphigus and Application to Other Auto-immune Diseases
Pemphigus is a rare autoimmune disease involving skin and mucous membranes characterized by the production of pathogenic autoantibodies directed against desmosomal transmembrane glycoproteins belonging to the cadherin family,responsible for the disruption of desmosomes leading to the acantholysis phenomenon.Two main classical subtypes of pemphigus have been individualized:pemphigus vulgaris and foliaceus,in which pathogenic autoantibodies are directed against desmoglein 3 and 1 respectively.The knowledge about B-cell populations responsible for pemphigus activity increased a lot.In pemphigus patients,B-cell population was shown to comprise auto-reactive B lymphocytes producing antibodies targeting desmogleins,directly responsible for disease activity,and regulatory B lymphocytes.After rituximab treatment,clinical activity was proved to be associated with circulating auto-antibodies high titers and an increase of auto-reactive B-cells,whereas clinical remission was associated with a change in B-cell populations,as B cell repertoire changed from oligoclonal to polyclonal when reconstituting after treatment,with an increase of immatures and transitional B-cells producing IL-10.The mechanisms leading to autoreactive B-cells appearance,the precise role of B-reg in immune tolerance and the factors triggering the imbalance between pro autoimmune and regulatory immune B-cells leading to pemphigus activity remain to be discovered.Polymorphonuclear neutrophil granulocytes(PMN) are the first responders of the immune system to threats by invading microorganisms.Since 2004, PMN were shown to produce neutrophil extracellular traps(NET),structures consisting of decondensed chromatin embedded with histones,granular and cytoplasmic proteins that trap and kill microbes.In lupus recent works demonstrated evidences that NETs components are found in immune complexes responsible for tissue inflammation and that polyclonal activation of B-cell as well as memory B-cell activation could be obtain in presence of immune complexes derived from NET.Besides lupus,other works showed evidence of NETs implication in inflammatory and auto-immune states in rheumatoid arthritis and small vessel vasculitis.The hypotheses is that B-cell activation by NET might not be restricted to autoimmune diseases of which antibodies target NETs components.The aim is to assess the effects on B-cell activation and the phenotypic changes in B-cell population from pemphigus patients after stimulation by NET.
Read the detailed description
Pemphigus is a rare autoimmune disease involving skin and mucous membranes with an incidence estimated as 0.7 to 7 new cases per million per year, responsible for non-negligible morbidity and mortality. Pemphigus is characterized by the production of pathogenic autoantibodies directed against two desmosomal proteins involved in keratinocyte adhesion (i.e. desmoglein 1 and desmoglein 3). These antibodies are responsible for the disruption of desmosomes leading to the acantholysis phenomenon, which results in the formation of skin and mucosal blisters. Two main classical subtypes of pemphigus have been individualized, pemphigus vulgaris (PV) and pemphigus foliaceus (PF), in which pathogenic autoantibodies are directed against desmosomal transmembrane glycoproteins belonging to the cadherin family, desmoglein 3, and desmoglein 1, respectively. As for many auto-immune diseases, high doses of corticosteroids (CS) remained the mainstay of first-line treatment for long time, alone or in conjunction with immunosuppressants. However, on these regimens, frequent relapses occurs when tapering CS dosage leading to long-term treatment and its associated risk of CS side effects.
Since ten years, the improvement in the knowledge of B-cell activation and survival, as well as their direct implication in auto-immune disease such as pemphigus through pathogenic auto-antibodies production, led to the identification of new therapeutic targets. New biological therapies based on B cell depletion were developed in severe autoimmune disorders, notably in pemphigus.
Several teams demonstrated the safety and efficacy of Rituximab, a chimeric immunoglobulin gamma-1(IgG1) monoclonal antibody(mAb) targeting the cluster of differentiation antigen 20(CD20) molecule expressed by normal B-cells from pre-B cells except for plasma cells, in severe pemphigus refractory to corticosteroids as well as in first line of treatment. Across these works, some of them concurred to improve the knowledge about B-cell populations responsible for pemphigus activity. In pemphigus patients, B-cell population was shown to comprise auto-reactive B lymphocytes producing antibodies targeting desmogleins, directly responsible for disease activity, and regulatory B lymphocytes (B-reg). After rituximab treatment of pemphigus patients, clinical activity was proved to be associated with circulating auto-antibodies high titers and an increase of auto-reactive B-cells, whereas clinical remission was associated with a change in B-cell populations, as B cell repertoire changed from oligoclonal to polyclonal when reconstituting after treatment, with an increase of immatures and transitional B-cells producing IL-10 (B-reg).
The mechanisms leading to autoreactive B-cells appearance, the precise role of B-reg in immune tolerance, and the factors triggering the imbalance between pro autoimmune and regulatory immune B-cells leading to pemphigus activity remain to be discovered. As for other auto-immune diseases, first flares and relapses were described following infectious events. Thus, infectious agents might trigger unknown mechanisms participating in the immune system imbalance by the activation of previously quiescent auto reactive B-cells or effector B-cells.
Polymorphonuclear neutrophil granulocytes (PMN) are the first responders of the immune system to threats by invading microorganisms; performing essential functions of innate immunity in host defence against a broad range of pathogens, notably by phagocytosis, intracellular degradation and extracellular discharge of antimicrobial factors. Since 2004, Polynuclear Neutral Neutrophil (PNN) were shown to produce neutrophil extracellular traps (NET), structures consisting of decondensed chromatin embedded with histones, granular and cytoplasmic proteins that trap and kill microbes. NET were initially consider to arise following cell death (NETosis) but NET formation was also described without PMN death with mitochondrial DNA extrusion. NET production during infectious events is responsible for the release of cytosolic, nuclear and mitochondrial antigens in the extracellular environment; this auto-antigen exposure constituting favourable conditions for autoimmune disease such as lupus erythematosus and AntiNeutrophil Cytoplasmic Antibody (ANCA) vasculitis, of which auto-antibodies targets belong to NET components (DNA, RNA, MPO, PR3). Besides antimicrobial function, an excessive production of NET or NET insufficient clearance were found to maintain tissue inflammation and excessive tissue damages that contribute to autoinflammatory and autoimmune diseases.
In lupus, recent works demonstrated evidences that NET components are found in immune complexes responsible for tissue inflammation and that polyclonal activation of B-cell as well as memory B-cell activation could be obtain in presence of immune complexes derived from NET.
Besides lupus, other works showed evidence of NET implication in inflammatory and auto-immune states in rheumatoid arthritis and small vessel vasculitis.
The investigators hypothesize that B-cell activation by NET might not be restricted to autoimmune diseases of which antibodies target NET components, as it is the case for lupus (DNA, RNA, LL37), Rheumatoid Arthritis(RA) (citrullinated proteins) or small vessel vasculitis (PR3, MPO).
Thus, the primary aim is to assess the effects on B-cell activation and the phenotypic changes in B-cell population from pemphigus patients after stimulation by neutrophil extracellular traps.
The secondary aim is to compare the results obtained in pemphigus patients to patients with other autoimmune diseases such as lupus, rheumatoid arthritis a Gougerot-Sjögren syndrome.
- Conditions
- Pemphigus Vulgaris, Pemphigus Foliaceus
- Being tested
- Blood sample
- Keywords
- Pemphigus Vulgaris, Pemphigus Foliaceus, B-cell, Dermatology
- Medical subject headings
- Pemphigus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
Collection of 2 blood sample : The first one at the inclusion in the study, the second one between 6 months and 9 months after the inclusion. The sample consists of 2 tubes of EthyleneDiamineTetraAcetic (EDTA) of 7 mL.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Pemphigus or other autoimmune diseases. Receives: Other: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Involvement of neutrophil extracellular traps (NETs) in the activation of B lymphocytes in Pemphigus
This primary outcome measure is composite. It will be verified according to the following points : Measurement of activation parameters of total, auto-reactive, and regulator B lymphocytes of patients :
- Quantification of membrane markers for activation of B lymphocytes (CD80, CD86, CD40)
- Quantification of the production of pro-inflammatory cytokines (IL-6, IL-8, Tumor Necrosis Factor alpha (TNF alpha), IFNγ) by total and auto-reactive B lymphocytes
- Quantification of the total production of immunoglobulins and antibodies specific for the disease
- Quantification of IL-10 and Tumor Growth Factor (TGF) beta production by regulatory B cells.
Measured: 9 months after inclusion
Secondary outcomes (4)
Demonstration that activation of the different sub-populations of B lymphocytes during NET exposure, if shown in pemphigus, is also in lupus, rheumatoid arthritis and Gougerot-Sjögren's syndrome relying on membrane markers for activation of B lymphocytes
Quantification of membrane markers for activation of B lymphocytes (CD80, Cluster of Differentiation antigen 86 (CD86), CD40);
Measured: 9 months after inclusion
Demonstration that activation of the different sub-populations of B lymphocytes during NET exposure, if shown in pemphigus, is also lupus, rheumatoid arthritis and Gougerot-Sjögren's syndrome relying on pro-inflammatory cytokines
Quantification of the production of pro-inflammatory cytokines (IL-6, IL-8, TNF-alpha(Tumor Necrosis Factor alpha), IFNγ) by total and auto-reactive B lymphocytes
Measured: 9 months after inclusion
Demonstration that activation of the different sub-populations of B lymphocytes during NET exposure, if shown in pemphigus, is also in lupus, rheumatoid arthritis and Gougerot-Sjögren's syndrome relying on immunoglobulins and antibodies
Quantification of the total production of immunoglobulins and antibodies specific for the disease
Measured: 9 months after inclusion
Demonstration that activation of the different sub-populations of B lymphocytes during NET exposure, if shown in pemphigus,is also in lupus,rheumatoid arthritis and Gougerot-Sjögren's syndrome relying on IL-10 and TGFbeta production by regulatory B cells
Quantification of IL-10 and TGFbeta production by regulatory B cells
Measured: 9 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2019
- Study start22 Oct 2019
- Primary completionJul 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pemphigus VulgarisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe MUSETTE, Pr, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04117529
- Sponsor's protocol ID
- APHP190199
- Other IDs
- 2019-A00533-54
- Acronym
- CaReLyBP
- Status last verified
- Dec 2020
- First submitted
- 26 Sep 2019
- Last updated
- 8 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Langan SM, Smeeth L, Hubbard R, Fleming KM, Smith CJ, West J. Bullous pemphigoid and pemphigus vulgaris--incidence and mortality in the UK: population based cohort study. BMJ. 2008 Jul 9;337(7662):a180. doi: 10.1136/bmj.a180.
PubMed 18614511Hashimoto T, Amagai M, Garrod DR, Nishikawa T. Immunofluorescence and immunoblot studies on the reactivity of pemphigus vulgaris and pemphigus foliaceus sera with desmoglein 3 and desmoglein 1. Epithelial Cell Biol. 1995;4(2):63-9.
PubMed 8688919Martel P, Joly P. Pemphigus: autoimmune diseases of keratinocyte's adhesion molecules. Clin Dermatol. 2001 Nov-Dec;19(6):662-74. doi: 10.1016/s0738-081x(00)00191-7. No abstract available.
PubMed 11705674Amagai M, Tsunoda K, Zillikens D, Nagai T, Nishikawa T. The clinical phenotype of pemphigus is defined by the anti-desmoglein autoantibody profile. J Am Acad Dermatol. 1999 Feb;40(2 Pt 1):167-70. doi: 10.1016/s0190-9622(99)70183-0.
PubMed 10025740Mahoney MG, Wang Z, Rothenberger K, Koch PJ, Amagai M, Stanley JR. Explanations for the clinical and microscopic localization of lesions in pemphigus foliaceus and vulgaris. J Clin Invest. 1999 Feb;103(4):461-8. doi: 10.1172/JCI5252.
PubMed 10021453
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenotypic and Functional Characterisation of Human B-cell Response in Pemphigus and Application to Other Auto-immune Diseases
- ClinicalTrials.gov ID
- NCT04117529
- Acronym / sponsor ID
- CaReLyBP / APHP190199
- Conditions
- Pemphigus Vulgaris, Pemphigus Foliaceus
- Keywords
- Pemphigus Vulgaris, Pemphigus Foliaceus, B-cell, Dermatology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 22 Oct 2019 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 7 Oct 2019 (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.
Pemphigus is a rare autoimmune disease involving skin and mucous membranes characterized by the production of pathogenic autoantibodies directed against desmosomal transmembrane glycoproteins belonging to the cadherin family,responsible for the disruption of desmosomes leading to the acantholysis phenomenon.Two main classical subtypes of pemphigus have been individualized:pemphigus vulgaris and foliaceus,in which pathogenic autoantibodies are directed against desmoglein 3 and 1 respectively.The knowledge about B-cell populations responsible for pemphigus activity increased a lot.In pemphigus patients,B-cell population was shown to comprise auto-reactive B lymphocytes producing antibodies targeting desmogleins,directly responsible for disease activity,and regulatory B lymphocytes.After rituximab treatment,clinical activity was proved to be associated with circulating auto-antibodies high titers and an increase of auto-reactive B-cells,whereas clinical remission was associated with a change in B-cell populations,as B cell repertoire changed from oligoclonal to polyclonal when reconstituting after treatment,with an increase of immatures and transitional B-cells producing IL-10.The mechanisms leading to autoreactive B-cells appearance,the precise role of B-reg in immune tolerance and the factors triggering the imbalance between pro autoimmune and regulatory immune B-cells leading to pemphigus activity remain to be discovered.Polymorphonuclear neutrophil granulocytes(PMN) are the first responders of the immune system to threats by invading microorganisms.Since 2004, PMN were shown to produce neutrophil extracellular traps(NET),structures consisting of decondensed chromatin embedded with histones,granular and cytoplasmic proteins that trap and kill microbes.In lupus recent works demonstrated evidences that NETs components are found in immune complexes responsible for tissue inflammation and that polyclonal activation of B-cell as well as memory B-cell activation could be obtain in presence of immune complexes derived from NET.Besides lupus,other works showed evidence of NETs implication in inflammatory and auto-immune states in rheumatoid arthritis and small vessel vasculitis.The hypotheses is that B-cell activation by NET might not be restricted to autoimmune diseases of which antibodies target NETs components.The aim is to assess the effects on B-cell activation and the phenotypic changes in B-cell population from pemphigus patients after stimulation by NET.
Detailed description
Pemphigus is a rare autoimmune disease involving skin and mucous membranes with an incidence estimated as 0.7 to 7 new cases per million per year, responsible for non-negligible morbidity and mortality. Pemphigus is characterized by the production of pathogenic autoantibodies directed against two desmosomal proteins involved in keratinocyte adhesion (i.e. desmoglein 1 and desmoglein 3). These antibodies are responsible for the disruption of desmosomes leading to the acantholysis phenomenon, which results in the formation of skin and mucosal blisters. Two main classical subtypes of pemphigus have been individualized, pemphigus vulgaris (PV) and pemphigus foliaceus (PF), in which pathogenic autoantibodies are directed against desmosomal transmembrane glycoproteins belonging to the cadherin family, desmoglein 3, and desmoglein 1, respectively. As for many auto-immune diseases, high doses of corticosteroids (CS) remained the mainstay of first-line treatment for long time, alone or in conjunction with immunosuppressants. However, on these regimens, frequent relapses occurs when tapering CS dosage leading to long-term treatment and its associated risk of CS side effects.
Since ten years, the improvement in the knowledge of B-cell activation and survival, as well as their direct implication in auto-immune disease such as pemphigus through pathogenic auto-antibodies production, led to the identification of new therapeutic targets. New biological therapies based on B cell depletion were developed in severe autoimmune disorders, notably in pemphigus.
Several teams demonstrated the safety and efficacy of Rituximab, a chimeric immunoglobulin gamma-1(IgG1) monoclonal antibody(mAb) targeting the cluster of differentiation antigen 20(CD20) molecule expressed by normal B-cells from pre-B cells except for plasma cells, in severe pemphigus refractory to corticosteroids as well as in first line of treatment. Across these works, some of them concurred to improve the knowledge about B-cell populations responsible for pemphigus activity. In pemphigus patients, B-cell population was shown to comprise auto-reactive B lymphocytes producing antibodies targeting desmogleins, directly responsible for disease activity, and regulatory B lymphocytes (B-reg). After rituximab treatment of pemphigus patients, clinical activity was proved to be associated with circulating auto-antibodies high titers and an increase of auto-reactive B-cells, whereas clinical remission was associated with a change in B-cell populations, as B cell repertoire changed from oligoclonal to polyclonal when reconstituting after treatment, with an increase of immatures and transitional B-cells producing IL-10 (B-reg).
The mechanisms leading to autoreactive B-cells appearance, the precise role of B-reg in immune tolerance, and the factors triggering the imbalance between pro autoimmune and regulatory immune B-cells leading to pemphigus activity remain to be discovered. As for other auto-immune diseases, first flares and relapses were described following infectious events. Thus, infectious agents might trigger unknown mechanisms participating in the immune system imbalance by the activation of previously quiescent auto reactive B-cells or effector B-cells.
Polymorphonuclear neutrophil granulocytes (PMN) are the first responders of the immune system to threats by invading microorganisms; performing essential functions of innate immunity in host defence against a broad range of pathogens, notably by phagocytosis, intracellular degradation and extracellular discharge of antimicrobial factors. Since 2004, Polynuclear Neutral Neutrophil (PNN) were shown to produce neutrophil extracellular traps (NET), structures consisting of decondensed chromatin embedded with histones, granular and cytoplasmic proteins that trap and kill microbes. NET were initially consider to arise following cell death (NETosis) but NET formation was also described without PMN death with mitochondrial DNA extrusion. NET production during infectious events is responsible for the release of cytosolic, nuclear and mitochondrial antigens in the extracellular environment; this auto-antigen exposure constituting favourable conditions for autoimmune disease such as lupus erythematosus and AntiNeutrophil Cytoplasmic Antibody (ANCA) vasculitis, of which auto-antibodies targets belong to NET components (DNA, RNA, MPO, PR3). Besides antimicrobial function, an excessive production of NET or NET insufficient clearance were found to maintain tissue inflammation and excessive tissue damages that contribute to autoinflammatory and autoimmune diseases.
In lupus, recent works demonstrated evidences that NET components are found in immune complexes responsible for tissue inflammation and that polyclonal activation of B-cell as well as memory B-cell activation could be obtain in presence of immune complexes derived from NET.
Besides lupus, other works showed evidence of NET implication in inflammatory and auto-immune states in rheumatoid arthritis and small vessel vasculitis.
The investigators hypothesize that B-cell activation by NET might not be restricted to autoimmune diseases of which antibodies target NET components, as it is the case for lupus (DNA, RNA, LL37), Rheumatoid Arthritis(RA) (citrullinated proteins) or small vessel vasculitis (PR3, MPO).
Thus, the primary aim is to assess the effects on B-cell activation and the phenotypic changes in B-cell population from pemphigus patients after stimulation by neutrophil extracellular traps.
The secondary aim is to compare the results obtained in pemphigus patients to patients with other autoimmune diseases such as lupus, rheumatoid arthritis a Gougerot-Sjögren syndrome.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Other: Blood samplePemphigus or other autoimmune diseases. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients man or woman
- Patients above 18 years old
- Patients fulfilling the diagnostic criteria for pemphigus (Lever et al, 1979), or for lupus (SLICC 2012), or for rheumatoid arthritis (ACR / EULAR 2009 criteria), or for Gougerot-Sjögren's syndrome (ACR criteria / EULAR 2016)
- Clinically active disease, defined by the presence of erosions or cutaneo-mucous bubbles for pemphigus, a SLEDAI score> 0 for lupus, a DAS28> 0 score for rheumatoid arthritis, and an EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score> 0 for Gougerot-Sjögren's syndrome
- Patients consenting to participate in the study
Key exclusion criteria (5 listed)
- Pregnant or lactating woman
- Patient already treated with biotherapy
- Patient already receiving treatment that may affect lymphocyte B populations: corticosteroid therapy> 10 mg / d or other immunosuppressant.
- Patient whose weight and / or hemoglobin level does not allow an additional blood sample during the assessment already provided by the treatment (according to the values in Appendix 2 of the Decree of April 12, 2018, which lists the research mentioned in 2 ° of Article L. 1121-1 of the Public Health Code)
- Person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampleCollection of 2 blood sample : The first one at the inclusion in the study, the second one between 6 months and 9 months after the inclusion. The sample consists of 2 tubes of EthyleneDiamineTetraAcetic (EDTA) of 7 mL. | Other | Experimental Arm |
Primary outcome
Involvement of neutrophil extracellular traps (NETs) in the activation of B lymphocytes in Pemphigus
Time frame: 9 months after inclusion
This primary outcome measure is composite. It will be verified according to the following points : Measurement of activation parameters of total, auto-reactive, and regulator B lymphocytes of patients : * Quantification of membrane markers for activation of B lymphocytes (CD80, CD86, CD40) * Quantification of the production of pro-inflammatory cytokines (IL-6, IL-8, Tumor Necrosis Factor alpha (TNF alpha), IFNγ) by total and auto-reactive B lymphocytes * Quantification of the total production of immunoglobulins and antibodies specific for the disease * Quantification of IL-10 and Tumor Growth Factor (TGF) beta production by regulatory B cells.
4 secondary outcomes
Demonstration that activation of the different sub-populations of B lymphocytes during NET exposure, if shown in pemphigus, is also in lupus, rheumatoid arthritis and Gougerot-Sjögren's syndrome relying on membrane markers for activation of B lymphocytes
Time frame: 9 months after inclusion
Demonstration that activation of the different sub-populations of B lymphocytes during NET exposure, if shown in pemphigus, is also lupus, rheumatoid arthritis and Gougerot-Sjögren's syndrome relying on pro-inflammatory cytokines
Time frame: 9 months after inclusion
Demonstration that activation of the different sub-populations of B lymphocytes during NET exposure, if shown in pemphigus, is also in lupus, rheumatoid arthritis and Gougerot-Sjögren's syndrome relying on immunoglobulins and antibodies
Time frame: 9 months after inclusion
Demonstration that activation of the different sub-populations of B lymphocytes during NET exposure, if shown in pemphigus,is also in lupus,rheumatoid arthritis and Gougerot-Sjögren's syndrome relying on IL-10 and TGFbeta production by regulatory B cells
Time frame: 9 months after inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2021.
- Background: PubMed 18614511Langan SM, Smeeth L, Hubbard R, Fleming KM, Smith CJ, West J. Bullous pemphigoid and pemphigus vulgaris--incidence and mortality in the UK: population based cohort study. BMJ. 2008 Jul 9;337(7662):a180. doi: 10.1136/bmj.a180.
- Background: PubMed 8688919Hashimoto T, Amagai M, Garrod DR, Nishikawa T. Immunofluorescence and immunoblot studies on the reactivity of pemphigus vulgaris and pemphigus foliaceus sera with desmoglein 3 and desmoglein 1. Epithelial Cell Biol. 1995;4(2):63-9.
- Background: PubMed 11705674Martel P, Joly P. Pemphigus: autoimmune diseases of keratinocyte's adhesion molecules. Clin Dermatol. 2001 Nov-Dec;19(6):662-74. doi: 10.1016/s0738-081x(00)00191-7. No abstract available.
- Background: PubMed 10025740Amagai M, Tsunoda K, Zillikens D, Nagai T, Nishikawa T. The clinical phenotype of pemphigus is defined by the anti-desmoglein autoantibody profile. J Am Acad Dermatol. 1999 Feb;40(2 Pt 1):167-70. doi: 10.1016/s0190-9622(99)70183-0.
- Background: PubMed 10021453Mahoney MG, Wang Z, Rothenberger K, Koch PJ, Amagai M, Stanley JR. Explanations for the clinical and microscopic localization of lesions in pemphigus foliaceus and vulgaris. J Clin Invest. 1999 Feb;103(4):461-8. doi: 10.1172/JCI5252.
- Individual participant dataSharing planned: No
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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.
Philippe MUSETTE, Pr principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample in people with Pemphigus Vulgaris and Pemphigus Foliaceus, run by Assistance Publique - Hôpitaux de Paris 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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 8 Jan 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammed RAHAOUI, Mr (+33148955977, mohammed.rahaoui@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Involvement of neutrophil extracellular traps (NETs) in the activation of B lymphocytes in Pemphigus (time frame: 9 months after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04117529, which also lists 5 linked publications.
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 8 Jan 2021.