PemphigoidSSENIORNCT02823067
Pruritus and Pemphigoid in Nursing Home Patients
An observational study of Pemphigoid and Pruritus, run by M.F. Jonkman at 1 site in Netherlands.
Trial summary
The primary objective of this observational study is to describe the prevalence of pruritus and pemphigoid in nursing home patients. Secondary outcomes are the relationships of demographic factors and medical risk factors with pemphigoid, including dementia and neuropsychiatric symptoms, medication use and Karnofsky… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Pemphigoid, Pruritus
- What is being tested?
- Blood sample
- How many people
- 125 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jun 2016to 1 Jan 2018
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: The study population will consist of 126 nursing home patients aged 65 years or above, living in a nursing home of the University Network Care of the Elderly - UMCG.
Who may be able to join
- Inpatient of a nursing home
- Age 65 years or above
- Subject or their official representatives have signed informed consent
Who cannot join
- Age below 65 years
- Subjects who do not have signed informed consent
- Receiving treatment with any systemic immunosuppressive agents
- Terminally ill patients with a life expectancy of less than 4 weeks
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this observational study is to describe the prevalence of pruritus and pemphigoid in nursing home patients. Secondary outcomes are the relationships of demographic factors and medical risk factors with pemphigoid, including dementia and neuropsychiatric symptoms, medication use and Karnofsky score.
Read the detailed description
Pruritus or itch is the most common skin symptom in elderly patients and is estimated to affect more than 30% of nursing home patients. Clinical and experimental evidence suggests pruritus in elderly patients may be linked to pemphigoid. Pemphigoid is the most common autoimmune skin blistering diseases and mainly affects the elderly. It is successfully treatable with systemic therapy. However, pemphigoid is often missed as a cause of pruritus in elderly patients (nonbullous cutaneous pemphigoid). Although nursing home patients and patients with dementia in particular have the highest risk for development of pemphigoid, no study has been performed in this population so far. Including serological screening for pemphigoid in the diagnostic evaluation of chronic pruritus in nursing home patients may lead to the diagnosis of pemphigoid. Furthermore, chronic itch may be an unrecognized cause of neuropsychiatric symptoms in nursing home patients with dementia.
- Conditions
- Pemphigoid, Pruritus
- Being tested
- Blood sample
- Keywords
- Pemphigoid, Bullous pemphigoid, Pruritus, Senile pruritus, Neuropsychiatric symptoms
- Medical subject headings
- Pemphigoid, Bullous, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
One extra blood sample of 10 ml will be taken during a routine venapunction for immunoserology testing.
| Study group | Role | What they receive |
|---|---|---|
| Nursing home patients | Nursing home patients aged 65 years or above. One extra blood sample of 10 ml will be taken during a routine venapunction for immunoserology testing. Receives: Other: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of pruritus
Presence and intensity of pruritus will be determined (hetero-)anamnestically with the Bullous Pemphigoid Disease Area Index (BPDAI) VAS score and derivative score for all subjects.
Measured: Day 1
Detection of circulating pemphigoid specific IgG autoantibodies by indirect immunofluorescence on 1M salt-split human skin substrate
IgG autoantibodies with epidermal side staining of artificial split; positive/negative, staining intensity IgG 1+,2+,3+
Measured: Day 1
Detection of circulating pemphigoid specific IgG autoantibodies by indirect immunofluorescence microscopy on monkey esophagus substrate
Anti-basement membrane zone IgG autoantibodies; positive/negative, staining intensity IgG 1+,2+,3+
Measured: Day 1
Concentration of anti-BP180 NC16A IgG autoantibodies by ELISA
Anti-BP180 NC16A IgG index; U/mL, cut-off value 9 U/mL
Measured: Day 1
Concentration of anti-BP230 IgG autoantibodies by ELISA
Anti-BP230 IgG index; U/mL, cut-off value 9 U/mL
Measured: Day 1
Detection of circulating pemphigoid specific IgG autoantibodies by immunoblot of keratinocyte extract
Presence/absence of circulating IgG autoantibodies against BP180 (180kDa) or BP230 (230kDa)
Measured: Day 1
Secondary outcomes (6)
Age
For all subjects
Measured: Day 1
Sex
For all subjects
Measured: Day 1
Comorbidities
Presence/absence of comorbidities dementia, cerebrovascular accident, Parkinson's disease, other neurological disease or other diseases
Measured: Day 1
Karnofsky Performance Scale
0% - 100%
Measured: Day 1
Medication
Registration of medication use for all subjects
Measured: Day 1
Neuropsychiatric symptoms
Neuropsychiatric Inventory - Nursing Home version in Dutch
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study start1 Jun 2016
- Primary completion1 Jan 2018
- Study completion1 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PemphigoidStudies of the same condition, open and under way.
- 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
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.F. Jonkman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, M.F. Jonkman, University Medical Center Groningen
- Investigators
- Marcel Jonkman, MD PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02823067
- Sponsor's protocol ID
- NL56232.042.15
- Other IDs
- METc 2015/605, NTR5843
- Acronym
- SSENIOR
- Status last verified
- Oct 2018
- First submitted
- 28 Jun 2016
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pruritus and Pemphigoid in Nursing Home Patients
- ClinicalTrials.gov ID
- NCT02823067
- Acronym / sponsor ID
- SSENIOR / NL56232.042.15
- Conditions
- Pemphigoid, Pruritus
- Keywords
- Pemphigoid, Bullous pemphigoid, Pruritus, Senile pruritus, Neuropsychiatric symptoms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- M.F. JonkmanUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 6 Jul 2016 (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 observational study is to describe the prevalence of pruritus and pemphigoid in nursing home patients. Secondary outcomes are the relationships of demographic factors and medical risk factors with pemphigoid, including dementia and neuropsychiatric symptoms, medication use and Karnofsky score.
Detailed description
Pruritus or itch is the most common skin symptom in elderly patients and is estimated to affect more than 30% of nursing home patients. Clinical and experimental evidence suggests pruritus in elderly patients may be linked to pemphigoid. Pemphigoid is the most common autoimmune skin blistering diseases and mainly affects the elderly. It is successfully treatable with systemic therapy. However, pemphigoid is often missed as a cause of pruritus in elderly patients (nonbullous cutaneous pemphigoid). Although nursing home patients and patients with dementia in particular have the highest risk for development of pemphigoid, no study has been performed in this population so far. Including serological screening for pemphigoid in the diagnostic evaluation of chronic pruritus in nursing home patients may lead to the diagnosis of pemphigoid. Furthermore, chronic itch may be an unrecognized cause of neuropsychiatric symptoms in nursing home patients with dementia.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nursing home patients | – | Other: Blood sampleNursing home patients aged 65 years or above. One extra blood sample of 10 ml will be taken during a routine venapunction for immunoserology testing. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The study population will consist of 126 nursing home patients aged 65 years or above, living in a nursing home of the University Network Care of the Elderly - UMCG.
Key inclusion criteria (3 listed)
- Inpatient of a nursing home
- Age 65 years or above
- Subject or their official representatives have signed informed consent
Key exclusion criteria (4 listed)
- Age below 65 years
- Subjects who do not have signed informed consent
- Receiving treatment with any systemic immunosuppressive agents
- Terminally ill patients with a life expectancy of less than 4 weeks
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 sampleOne extra blood sample of 10 ml will be taken during a routine venapunction for immunoserology testing. | Other | Nursing home patients |
Primary outcome
Presence of pruritus
Time frame: Day 1
Presence and intensity of pruritus will be determined (hetero-)anamnestically with the Bullous Pemphigoid Disease Area Index (BPDAI) VAS score and derivative score for all subjects.
Detection of circulating pemphigoid specific IgG autoantibodies by indirect immunofluorescence on 1M salt-split human skin substrate
Time frame: Day 1
IgG autoantibodies with epidermal side staining of artificial split; positive/negative, staining intensity IgG 1+,2+,3+
Detection of circulating pemphigoid specific IgG autoantibodies by indirect immunofluorescence microscopy on monkey esophagus substrate
Time frame: Day 1
Anti-basement membrane zone IgG autoantibodies; positive/negative, staining intensity IgG 1+,2+,3+
Concentration of anti-BP180 NC16A IgG autoantibodies by ELISA
Time frame: Day 1
Anti-BP180 NC16A IgG index; U/mL, cut-off value 9 U/mL
Concentration of anti-BP230 IgG autoantibodies by ELISA
Time frame: Day 1
Anti-BP230 IgG index; U/mL, cut-off value 9 U/mL
Detection of circulating pemphigoid specific IgG autoantibodies by immunoblot of keratinocyte extract
Time frame: Day 1
Presence/absence of circulating IgG autoantibodies against BP180 (180kDa) or BP230 (230kDa)
6 secondary outcomes
Age
Time frame: Day 1
Sex
Time frame: Day 1
Comorbidities
Time frame: Day 1
Karnofsky Performance Scale
Time frame: Day 1
Medication
Time frame: Day 1
Neuropsychiatric symptoms
Time frame: Day 1
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 15 Oct 2018.
- Individual participant dataSharing planned: Undecided
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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.
Marcel Jonkman, MD PhD principal investigator
University Medical Center Groningen
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 and Pruritus, run by M.F. Jonkman at 1 site in Netherlands.
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 3 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 15 Oct 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 Netherlands. 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?
Presence of pruritus (time frame: Day 1). The study lists 6 primary outcomes in all. 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 15 Oct 2018.