Pemphigoid, BullousNCT01559155
Role of Proteasomes in a Dermatological Autoimmune Disease: Bullous Pemphigoid
An observational study of Pemphigoid, Bullous and Pemphigus, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The primary objective of this study is to describe and compare plasmatic anti-proteasome auto-antibody concentrations among three distinct groups: (1) patients suffering from bullous pemphigoide; (2) patients suffering from other dermatological auto-immune diseases; (3) an elderly control group. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pemphigoid, Bullous, Pemphigus, Lupus Erythematosus, Cutaneous
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- 5 Nov 2013to 9 Jun 2015
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population is composed of three groups: (1) 50 patients with newly diagnosed (untreated) bullous pemphigoid, (2) 50 control patients matched for age and sex with the previous group and (3) 30 patients with other dermatological auto-immune disease (15 pemphigus + 15 cutaneous lupus).
Who may be able to join
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- The patient is not taking systemic treatment
- The patient has not been treated with topical steroids for more than 15 days.
- For the bullous pemphigoid group:
- clinical signs: erythematous-based lesions, especially on flexion areas of the arms and legs, not afflicting mucous membranes, and without atrophic scaring
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- histology: without epidermal acantholysis
- For the pemphigus group:
- patient with pemphigus
- For the lupus group:
- systemic lupus patients: presence of the 4 diagnostic criteria for systemic lupus erythematosus as defined by the American College of Rheumatology (amended 1997)
- or characteristics of subacute cutaneous lupus: clinical, histological and immunological (anti-SSa)
- or clinical and histological characteristics of chronic lupus
- For the control group:
- hospitalized patients with no history of auto-immune, inflammatory or evolving neoplastic disease
Who cannot join
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
- The patient is pregnant, parturient, or breastfeeding
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- For patients with bullous pemphigoid, pemphigus or lupus:
- The patient is taking systemic treatment
- The patient has been taking topical steroids for more than 15 days.
- For the controls:
- autoimmune disease
- inflammatory disease
- evolving neoplastic disease
- surgery during the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this study is to describe and compare plasmatic anti-proteasome auto-antibody concentrations among three distinct groups: (1) patients suffering from bullous pemphigoide; (2) patients suffering from other dermatological auto-immune diseases; (3) an elderly control group.
Read the detailed description
The secondary objectives of this study are:
To compare the following parameters between the 3 groups:
- plasmatic proteasome concentrations
- plasmatic proteasome proteolytic activity
To explore the potential relationships between:
- plasmatic proteasome concentrations
- plasmatic proteasome proteolytic activity
- plasmatic anti-proteasome auto-antibody concentrations
- measures of disease severity for dermatological auto-immune diseases
To characterize plasmatic anti-proteasome auto-antibodies in patients suffering from bullous pemphigoide and other dermatological auto-immune diseases (other bullous auto immune diseases: pemphigus, cutaneous lupus, ...).
To characterize the expression and the activity of proteasomes in skin samples, in plasma and in circulating mononuclear cells in patients with bullous pemphigoide.
- Keywords
- proteasomes, proteasome concentration, disease activity, proteolytic activity, autoantibodies, proteasome autoantibody
- Medical subject headings
- Pemphigoid, Bullous, Pemphigus, Lupus Erythematosus, Cutaneous
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 |
|---|---|---|
| Bullous pemphigoid | Patients in this cohort are newly diagnosed (or have not started treatment) with bullous pemphigoid | |
| Other bullous-like auto-immune | Patients in this cohort are newly diagnosed (or have not started treatment) with pemphigus (15 patients) or cutaneous lupus (15 patients) | |
| Control group | Patients in this cohort are hospitalized at the Nîmes University Hospital, and have no history of autoimmune, inflammatory or neoplastic disease. Patients are matched for age and sex with patients in the bullous pemphigoid cohort. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasmatic concentration of anti-proteasome autoantibodies (ng/ml)
Measured: baseline
Secondary outcomes (18)
the daily number of new lesions
For patients suffering from bullous pemphigoid or pemphigus: the daily number of new lesions for the 3 days preceding blood sampling
Measured: baseline
Presence/absence of mucosal disease
For patients suffering from bullous pemphigoid only
Measured: baseline
Disease duration (weeks)
For patients suffering from bullous pemphigoid or pemphigus or lupus
Measured: baseline
% surface area
For patients suffering from bullous pemphigoid or pemphigus or lupus: % of skin area affected in relation to total area
Measured: baseline
Puritis score
For patients suffering from bullous pemphigoid only: severity of itching on a analog scale varying from 0 to 6
Measured: baseline
concentration of anti-PB18 antibodies, measured by ELISA
For patients suffering from bullous pemphigoid only; U/ml
Measured: baseline
Immunohistochemistry
For the first 10 patients suffering from bullous pemphigoid included at the Nîmes University Hospital only; Skin biopsy immunohistochemistry scores for the pan-alpha, alpha6, beta1, beta2, beta1i, beta5i and rpt5 subunits (negative, weak, moderate, strong)
Measured: baseline
Tissue DNA expression
For the first 10 patients suffering from bullous pemphigoid included at the Nîmes University Hospital only; Skin biopsy, plasma and circulating mononuclear cell DNA expression for the pan-alpha, alpha6, beta1, beta2, beta1i, beta5i and rpt5 subunits (weighted by beta-actin)
Measured: baseline
presence/absence of oral lesions
For patients suffering from pemphigus
Measured: baseline
Presence/absence of Nikolsky's sign
For patients with pemphigus only
Measured: baseline
Pemphigus disease area index
For patients with Pemphigus only; score varying from 0 to 120.
Measured: baseline
Anti-desmogleine 1 and 3 antibody concentrations
For patients with Pemphigus only; ELISA (U/ml
Measured: baseline
CLASI score for lupus
for lupus patients only; score varying from 0 to 70
Measured: baseline
Karnofsky's score (%)
Measured: baseline
Plasma proteasome concentration
ng/ml
Measured: baseline
% trypsin-like plasma proteasome proteolytic activity
Measured: baseline
% chymotrypsin-like plasma proteasome proteolytic activity
Measured: baseline
% caspase-like plasma proteasome proteolytic activity
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2012 (estimated)
- Study start5 Nov 2013
- Primary completion9 Jun 2015
- Study completion9 Jun 2015
Why it stopped: recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pemphigoid, BullousStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Cross-sectional
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre Stoebner, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01559155
- Sponsor's protocol ID
- LOCAL/2011/PS-02
- Other IDs
- 2012-A00180-43
- Status last verified
- May 2018
- First submitted
- 19 Mar 2012
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Proteasomes in a Dermatological Autoimmune Disease: Bullous Pemphigoid
- ClinicalTrials.gov ID
- NCT01559155
- Acronym / sponsor ID
- LOCAL/2011/PS-02
- Keywords
- proteasomes, proteasome concentration, disease activity, proteolytic activity, autoantibodies, proteasome autoantibody
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: recruitment difficulties
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 5 Nov 2013 (actual)
- Primary completion
- 9 Jun 2015 (actual)
- Study completion
- 9 Jun 2015 (actual)
- First posted
- 21 Mar 2012 (estimated)
- 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 primary objective of this study is to describe and compare plasmatic anti-proteasome auto-antibody concentrations among three distinct groups: (1) patients suffering from bullous pemphigoide; (2) patients suffering from other dermatological auto-immune diseases; (3) an elderly control group.
Detailed description
The secondary objectives of this study are:
To compare the following parameters between the 3 groups:
- plasmatic proteasome concentrations
- plasmatic proteasome proteolytic activity
To explore the potential relationships between:
- plasmatic proteasome concentrations
- plasmatic proteasome proteolytic activity
- plasmatic anti-proteasome auto-antibody concentrations
- measures of disease severity for dermatological auto-immune diseases
To characterize plasmatic anti-proteasome auto-antibodies in patients suffering from bullous pemphigoide and other dermatological auto-immune diseases (other bullous auto immune diseases: pemphigus, cutaneous lupus, ...).
To characterize the expression and the activity of proteasomes in skin samples, in plasma and in circulating mononuclear cells in patients with bullous pemphigoide.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bullous pemphigoid | – | –Patients in this cohort are newly diagnosed (or have not started treatment) with bullous pemphigoid |
| Other bullous-like auto-immune | – | –Patients in this cohort are newly diagnosed (or have not started treatment) with pemphigus (15 patients) or cutaneous lupus (15 patients) |
| Control group | – | –Patients in this cohort are hospitalized at the Nîmes University Hospital, and have no history of autoimmune, inflammatory or neoplastic disease. Patients are matched for age and sex with patients in the bullous pemphigoid cohort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is composed of three groups: (1) 50 patients with newly diagnosed (untreated) bullous pemphigoid, (2) 50 control patients matched for age and sex with the previous group and (3) 30 patients with other dermatological auto-immune disease (15 pemphigus + 15 cutaneous lupus).
Key inclusion criteria (15 listed)
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- The patient is not taking systemic treatment
- The patient has not been treated with topical steroids for more than 15 days.
- clinical signs: erythematous-based lesions, especially on flexion areas of the arms and legs, not afflicting mucous membranes, and without atrophic scaring
Key exclusion criteria (14 listed)
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
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
Plasmatic concentration of anti-proteasome autoantibodies (ng/ml)
Time frame: baseline
18 secondary outcomes
the daily number of new lesions
Time frame: baseline
Presence/absence of mucosal disease
Time frame: baseline
Disease duration (weeks)
Time frame: baseline
% surface area
Time frame: baseline
Puritis score
Time frame: baseline
concentration of anti-PB18 antibodies, measured by ELISA
Time frame: baseline
Immunohistochemistry
Time frame: baseline
Tissue DNA expression
Time frame: baseline
presence/absence of oral lesions
Time frame: baseline
Presence/absence of Nikolsky's sign
Time frame: baseline
Pemphigus disease area index
Time frame: baseline
Anti-desmogleine 1 and 3 antibody concentrations
Time frame: baseline
CLASI score for lupus
Time frame: baseline
Karnofsky's score (%)
Time frame: baseline
Plasma proteasome concentration
Time frame: baseline
% trypsin-like plasma proteasome proteolytic activity
Time frame: baseline
% chymotrypsin-like plasma proteasome proteolytic activity
Time frame: baseline
% caspase-like plasma proteasome proteolytic activity
Time frame: baseline
Results and safety
The study was stopped early (reason given: recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
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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.
Pierre Stoebner, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
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 Pemphigoid, Bullous and Pemphigus, run by Centre Hospitalier Universitaire de Nīmes 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 15 inclusion and 14 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: stopped early, as of the sponsor's last update on 11 May 2018. 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 was stopped early (reason given: recruitment difficulties). Results are not available in the source record.
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?
Plasmatic concentration of anti-proteasome autoantibodies (ng/ml) (time frame: baseline). 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 11 May 2018.