Bullous PemphigoidNCT03636763
Dipeptidyl Peptidase-IV Inhibitors, Risk Factor for Development of Bullous Pemphigoid?
An observational study of Bullous Pemphigoid, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Bullous pemphigoid (BP) is the most common autoimmune bullous dermatosis. It mainly affects the elderly, and its cutaneous manifestations are extremely varied. Since the publication of the first case of PB associated with sulfasalazine in 1970, several drugs have been reported for their potential link with the… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bullous Pemphigoid
- What is being tested?
- data report
- How many people
- 183 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2018to Dec 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients from three university departments of Dermatology with type 2 diabetes and a diagnosis of PB diagnosed for the first time between January 1, 2014 and July 31, 2016
Who may be able to join
- Case: Patients from three university departments of Dermatology (Marseille North, Marseille La Timone, Bern) with type 2 diabetes, and a diagnosis of PB diagnosed for the first time between January 1, 2014 and July 31, 2016. The diagnosis of PB is based on compatible clinical presentation, compatible histology, positive direct immunofluorescence (IFD), and in some cases positive indirect immunofluorescence (IFI) and / or the presence of autoantibodies (BP180 and / or BP230) by ELISA.
- Witnesses: Patients from two university departments of Endocrinology (Marseille La Conception and Bern) with type 2 diabetes, and matched 1: 2 to cases for sex and age.
Who cannot join
- Case: Patients with another bullous dermatosis, not meeting the inclusion criteria. Patients biopsied before consultation in University Hospital, or patients seen in private dermatology practices.
- Witnesses: Patients suffering at the time of inclusion of a chronic dermatosis, in particular of a bullous dermatosis.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Assistance Publique Des Hopitaux de Marseille
Marseille, PACA, 13354
MICHAEL BENZAQUEN, +33 491964962, MICHAEL.BENZAQUEN@ap-hm.fr
About this study
Official title: Dipeptidyl Peptidase-IV Inhibitors, Risk Factor for Development of Bullous Pemphigoid? : Multicenter Retrospective Study in France and Switzerland
Bullous pemphigoid (BP) is the most common autoimmune bullous dermatosis. It mainly affects the elderly, and its cutaneous manifestations are extremely varied. Since the publication of the first case of PB associated with sulfasalazine in 1970, several drugs have been reported for their potential link with the development of PB. Recently, cases of PB associated with dipeptidyl peptidase-IV (DPP4) inhibitors, also known as gliptins, have been reported. DPP4 inhibitors are oral antidiabetic agents prescribed to patients with type 2 diabetes, as monotherapy, in combination with other oral antidiabetic agents or with insulin.
In recent years, an increasing number of cases have been published, describing the potential role of gliptins in PB induction. All these clinical cases and pharmacovigilance analyzes tend to show an increased risk of developing BP in case of gliptin exposure.
Read more
The main objective is to evaluate the risk of developing a PB under DPP4 inhibitor treatment, comparing cases of diabetic patients with BP, to matched diabetic controls for sex and age, from French departments. Endocrinology in a retrospective study from 1 January 2014 to 31 July 2016.
The study will be conducted using databases of clinical and histological records. The investigators will perform a retrospective 1: 2 case-control study comparing cases with type 2 diabetes and BP to matched diabetic controls for sex and age, randomly drawn from French endocrinology departments (Marseille La Conception ) and Switzerland (Bern), between January 1, 2014 and July 31, 2016. the investigators will compare gliptin exposure in the case-control group versus the control group, adjusting for potential confounding bias using models. logistic regression.
Read the detailed description
Bullous pemphigoid (BP) is the most common autoimmune bullous dermatosis. It mainly affects the elderly, and its cutaneous manifestations are extremely varied. Since the publication of the first case of PB associated with sulfasalazine in 1970, several drugs (spironolactone, furosemide, chloroquine, beta-blockers and various antibiotics) have been reported for their potential link with the development of PB. Recently, cases of PB associated with dipeptidyl peptidase-IV (DPP4) inhibitors, also known as gliptins, have been reported. DPP4 inhibitors are oral antidiabetic agents prescribed to patients with type 2 diabetes, as monotherapy, in combination with other oral antidiabetic agents or with insulin.
Problem raised:
In recent years, an increasing number of cases have been published, describing the potential role of gliptins in PB induction. All these clinical cases and pharmacovigilance analyzes tend to show an increased risk of developing BP in case of gliptin exposure, but this hypothesis has not yet been confirmed by a quality controlled study.
Goal:
The main objective is to evaluate the risk of developing a PB under DPP4 inhibitor treatment, comparing cases of diabetic patients with BP, to matched diabetic controls for sex and age, from French departments. Endocrinology (Marseille La Conception) and Dermatologie (Marseille North, Marseille La Timone) and Swiss (Bern), in a retrospective study from 1 January 2014 to 31 July 2016.
Material and methods:
The study will be conducted in three university departments of Dermatology (Marseille North, Marseille La Timone, Bern), using databases of clinical and histological records. The investigators will perform a retrospective 1: 2 case-control study comparing cases with type 2 diabetes and BP to matched diabetic controls for sex and age, randomly drawn from French endocrinology departments (Marseille La Conception ) and Switzerland (Bern), between January 1, 2014 and July 31, 2016. The investigators will compare gliptin exposure in the case-control group versus the control group, adjusting for potential confounding bias using models. logistic regression.
Criteria for inclusion:
- Case: Patients from three university departments of Dermatology (Marseille North, Marseille La Timone, Bern) with type 2 diabetes, and a diagnosis of PB diagnosed for the first time between January 1, 2014 and July 31, 2016. The diagnosis of PB is based on compatible clinical presentation, compatible histology, positive direct immunofluorescence (IFD), and in some cases positive indirect immunofluorescence (IFI) and / or the presence of autoantibodies (BP180 and / or BP230) by ELISA.
- Witnesses: Patients from two university departments of Endocrinology (Marseille La Conception and Bern) with type 2 diabetes, and matched 1: 2 to cases for sex and age.
Exclusion criteria:
- Case: Patients with another bullous dermatosis, not meeting the inclusion criteria. Patients biopsied before consultation in University Hospital, or patients seen in private dermatology practices.
- Witnesses: Patients suffering at the time of inclusion of a chronic dermatosis, in particular of a bullous dermatosis.
- Conditions
- Bullous Pemphigoid
- Being tested
- data report
- Medical subject headings
- Pemphigoid, Bullous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
data reportDrug
Also called gliptin
the information "gliptin exposure" will be reported
| Study group | Role | What they receive |
|---|---|---|
| Bullous pemphigoid and diabetes 2 | patients with Bullous pemphigoid and diabete type 2 data report about gliptin exposure will be performed Receives: Drug: data report | |
| diabete type 2 | patients with diabetes type 2 data report about gliptin exposure will be performed Receives: Drug: data report |
What is being measured
The primary outcome is the main question the study is designed to answer.
numbers of patients exposed to gliptin
numbers of patients exposed to gliptin developing a Bullous pemphigoid
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study startSep 2018 (estimated)
- Primary completionMar 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bullous PemphigoidStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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-control
- Time perspective
- Retrospective
- Enrolment
- 183 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- EMILIE GARRIDO PRADALIE, Study director, APHM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03636763
- Sponsor's protocol ID
- 2017-29
- Status last verified
- Aug 2018
- First submitted
- 16 Aug 2018
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dipeptidyl Peptidase-IV Inhibitors, Risk Factor for Development of Bullous Pemphigoid? : Multicenter Retrospective Study in France and Switzerland
- ClinicalTrials.gov ID
- NCT03636763
- Acronym / sponsor ID
- 2017-29
- Conditions
- Bullous Pemphigoid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 183 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Sep 2018 (estimated)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 17 Aug 2018 (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.
Bullous pemphigoid (BP) is the most common autoimmune bullous dermatosis. It mainly affects the elderly, and its cutaneous manifestations are extremely varied. Since the publication of the first case of PB associated with sulfasalazine in 1970, several drugs have been reported for their potential link with the development of PB. Recently, cases of PB associated with dipeptidyl peptidase-IV (DPP4) inhibitors, also known as gliptins, have been reported. DPP4 inhibitors are oral antidiabetic agents prescribed to patients with type 2 diabetes, as monotherapy, in combination with other oral antidiabetic agents or with insulin.
In recent years, an increasing number of cases have been published, describing the potential role of gliptins in PB induction. All these clinical cases and pharmacovigilance analyzes tend to show an increased risk of developing BP in case of gliptin exposure.
The main objective is to evaluate the risk of developing a PB under DPP4 inhibitor treatment, comparing cases of diabetic patients with BP, to matched diabetic controls for sex and age, from French departments. Endocrinology in a retrospective study from 1 January 2014 to 31 July 2016.
The study will be conducted using databases of clinical and histological records. The investigators will perform a retrospective 1: 2 case-control study comparing cases with type 2 diabetes and BP to matched diabetic controls for sex and age, randomly drawn from French endocrinology departments (Marseille La Conception ) and Switzerland (Bern), between January 1, 2014 and July 31, 2016. the investigators will compare gliptin exposure in the case-control group versus the control group, adjusting for potential confounding bias using models. logistic regression.
Detailed description
Bullous pemphigoid (BP) is the most common autoimmune bullous dermatosis. It mainly affects the elderly, and its cutaneous manifestations are extremely varied. Since the publication of the first case of PB associated with sulfasalazine in 1970, several drugs (spironolactone, furosemide, chloroquine, beta-blockers and various antibiotics) have been reported for their potential link with the development of PB. Recently, cases of PB associated with dipeptidyl peptidase-IV (DPP4) inhibitors, also known as gliptins, have been reported. DPP4 inhibitors are oral antidiabetic agents prescribed to patients with type 2 diabetes, as monotherapy, in combination with other oral antidiabetic agents or with insulin.
Problem raised:
In recent years, an increasing number of cases have been published, describing the potential role of gliptins in PB induction. All these clinical cases and pharmacovigilance analyzes tend to show an increased risk of developing BP in case of gliptin exposure, but this hypothesis has not yet been confirmed by a quality controlled study.
Goal:
The main objective is to evaluate the risk of developing a PB under DPP4 inhibitor treatment, comparing cases of diabetic patients with BP, to matched diabetic controls for sex and age, from French departments. Endocrinology (Marseille La Conception) and Dermatologie (Marseille North, Marseille La Timone) and Swiss (Bern), in a retrospective study from 1 January 2014 to 31 July 2016.
Material and methods:
The study will be conducted in three university departments of Dermatology (Marseille North, Marseille La Timone, Bern), using databases of clinical and histological records. The investigators will perform a retrospective 1: 2 case-control study comparing cases with type 2 diabetes and BP to matched diabetic controls for sex and age, randomly drawn from French endocrinology departments (Marseille La Conception ) and Switzerland (Bern), between January 1, 2014 and July 31, 2016. The investigators will compare gliptin exposure in the case-control group versus the control group, adjusting for potential confounding bias using models. logistic regression.
Criteria for inclusion:
- Case: Patients from three university departments of Dermatology (Marseille North, Marseille La Timone, Bern) with type 2 diabetes, and a diagnosis of PB diagnosed for the first time between January 1, 2014 and July 31, 2016. The diagnosis of PB is based on compatible clinical presentation, compatible histology, positive direct immunofluorescence (IFD), and in some cases positive indirect immunofluorescence (IFI) and / or the presence of autoantibodies (BP180 and / or BP230) by ELISA.
- Witnesses: Patients from two university departments of Endocrinology (Marseille La Conception and Bern) with type 2 diabetes, and matched 1: 2 to cases for sex and age.
Exclusion criteria:
- Case: Patients with another bullous dermatosis, not meeting the inclusion criteria. Patients biopsied before consultation in University Hospital, or patients seen in private dermatology practices.
- Witnesses: Patients suffering at the time of inclusion of a chronic dermatosis, in particular of a bullous dermatosis.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bullous pemphigoid and diabetes 2 | – | Drug: data reportpatients with Bullous pemphigoid and diabete type 2 data report about gliptin exposure will be performed |
| diabete type 2 | – | Drug: data reportpatients with diabetes type 2 data report about gliptin exposure will be performed |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients from three university departments of Dermatology with type 2 diabetes and a diagnosis of PB diagnosed for the first time between January 1, 2014 and July 31, 2016
Key inclusion criteria (2 listed)
- Case: Patients from three university departments of Dermatology (Marseille North, Marseille La Timone, Bern) with type 2 diabetes, and a diagnosis of PB diagnosed for the first time between January 1, 2014 and July 31, 2016. The diagnosis of PB is based on compatible clinical presentation, compatible histology, positive direct immunofluorescence (IFD), and in some cases positive indirect immunofluorescence (IFI) and / or the presence of autoantibodies (BP180 and / or BP230) by ELISA.
- Witnesses: Patients from two university departments of Endocrinology (Marseille La Conception and Bern) with type 2 diabetes, and matched 1: 2 to cases for sex and age.
Key exclusion criteria (2 listed)
- Case: Patients with another bullous dermatosis, not meeting the inclusion criteria. Patients biopsied before consultation in University Hospital, or patients seen in private dermatology practices.
- Witnesses: Patients suffering at the time of inclusion of a chronic dermatosis, in particular of a bullous dermatosis.
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 |
|---|---|---|
| data reportAlso: gliptinthe information "gliptin exposure" will be reported | Drug | Bullous pemphigoid and diabetes 2, diabete type 2 |
Primary outcome
numbers of patients exposed to gliptin
Time frame: 3 years
numbers of patients exposed to gliptin developing a Bullous pemphigoid
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 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.
EMILIE GARRIDO PRADALIE study director
APHM
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 Bullous Pemphigoid, run by Assistance Publique Hopitaux De Marseille 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 2 inclusion and 2 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 17 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Joseph BENZAQUEN (+33 491964962, MICHAEL.BENZAQUEN@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
numbers of patients exposed to gliptin (time frame: 3 years). 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 17 Aug 2018.