PsoriasisIMAPANCT03399708
Immune Metabolic Associations in Psoriatic Arthritis
An observational study of Psoriasis and Psoriatic Arthritis, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
Trial summary
To use apremilast in clinical practice as a molecular probe to evaluate the effects of PDE4 inhibition on the cardiometabolic status and immune profile in patients with PsA and psoriasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis, Psoriatic Arthritis
- What is being tested?
- Apremilast 30mg
- Type of treatment
- Pill or oral medicine
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Jun 2017to 25 Oct 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with PsA and psoriasis.
Who may be able to join
- Age ≥ 18 years
- Have either a diagnosis of PsA (n=40) fulfilling the CASPAR criteria or Chronic plaque psoriasis (confirmed by dermatologist) (n=20)
- Eligible for apremilast therapy in line with the licence and SMC approval
- Able and willing to give written informed consent and comply with the requirements of the study protocol.
Who cannot join
- History of or current autoimmune rheumatic disease other than PsA or psoriasis
- Severe renal disease (eGFR ≤30ml/min)
- Liver disease with ALT/AST >4 times ULN
- Haemoglobin ≤9 g/dl
- Inflammatory bowel disease or coeliac disease
- Patients with any cancer currently receiving chemo- or radiotherapy
Show all 20Show fewer
- Severe depression and/or history of suicidal ideation or attempts.
- Currently receiving other leflunomide or biologics
- Current oral steroids or IM steroids within 6 weeks of baseline.
- Clinically meanigful weight loss of >3kg, current or planned use of weight loss medication e.g. orlistat, or severe calorie restriction within the first 3 months of the study
- Current insulin therapy for diabetes
- Current use of GLP-1 agonists or dipeptidyl peptidase-4 (DPP-IV) inhibitors
- Statin therapy started/stopped or dose altered within 3 months of baseline visit
- Thyroxine started or dose altered within 6 weeks of baseline
- Acitretin within 8 weeks of baseline
- Pregnancy or breast feeding
- Women planning to become pregnant during the study period
- Women of reproductive age or male partners of women of reproductive age unwilling to use effective contraception while taking apremilast \& for at least 28 days after last dose of apremilast
- Known HIV, hepatitis B and C infection
- Patient unable to participate in long term data collection
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Glasgow Royal Infirmary
Glasgow, Scotland, G31 2ER
About this study
Official title: Immune Metabolic Associations in Psoriatic Arthritis Study
To use apremilast in clinical practice as a molecular probe to evaluate the effects of PDE4 inhibition on the cardiometabolic status and immune profile in patients with PsA and psoriasis.
Read the detailed description
Psoriatic arthritis (PsA) and psoriasis are characterised by immune, metabolic, and vascular dysfunction. There is an increase in Major Adverse Cardiovascular Events in people with PsA and psoriasis not explained by conventional cardiovascular risk factors. Furthermore, obesity in psoriasis is associated with increased risk of developing PsA3. Dietary interventions leading to weight loss >5% are associated with a higher rate of achievement of minimal disease activity in overweight/obese patients with PsA treated with TNF inhibitors. Phosphodiesterase 4 (PDE4) inhibition with apremilast is licensed for the treatment of PsA and psoriasis and has been noted to be associated with weight loss. There is also data from animal models to suggest a role for PDE4 in glucose metabolism. However, the exact mechanisms underlying this are unclear and warrant investigation in humans. PDE4 may help explain the link between the immune and cardiometabolic dysfunction that characterises PsA and psoriasis, with pathogenic and therapeutic implications.
This study aims to use apremilast as a clinical molecular probe to evaluate the effects of PDE4 inhibition on metabolic, vascular, and immune status in patients with PsA and psoriasis. The hypothesis is that PDE4 inhibition mediates profound and synergistic effects on immune and metabolic pathways in these conditions to improve metabolic status and normalise dysregulated immunity.
Measurement of metabolic, immunological and vascular outcomes in 60 patients (40 with PsA and 20 with psoriasis) receiving apremilast as part of their standard clinical care will be taken. A subgroup of 20 participants with PsA will also undergo more in-depth investigations including MRI of abdominal fat, subcutaneous fat biopsy, measurement of vascular endothelial function using EndoPAT and more detailed deep-immunophenotyping. Patients will be recruited from rheumatology and dermatology clinics in NHS Greater Glasgow and Clyde (primary site) and two other recruiting sites in Scotland via the Scottish Collaborative Arthritis Research network (SCAR).
- Conditions
- Psoriasis, Psoriatic Arthritis
- Being tested
- Apremilast 30mg
- Keywords
- apremilast, PDE4 inhibition, cardiometabolic, immune profile
- Medical subject headings
- Psoriasis, Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apremilast 30mgDrug
Apremilast will used in line with its license. This includes the standard dose titration scheme (see section 6) and then the usual maintenance dose of 30 mg twice daily orally.
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cardiometabolic profile
To characterise dynamic changes in cardiometabolic profile with formal assessment at 3 months.
Measured: 3 months
Secondary outcomes (8)
Lipids
Change in lipid profile
Measured: 6 months
NMR metabolomic profile
Change in NMR metabolomic profile
Measured: 6 months
Blood pressure
Change in blood pressure
Measured: 6 months
endothelial function
change in endothelial function
Measured: 3 months
MRI imaging
change in visceral, subcutaneous, liver, and pancreatic fat as assessed by MRI imaging
Measured: 3 months
GLP-1 levels
Change in fasting \& post-prandial GLP-1 levels
Measured: 6 months
adipose tissue
Change in adipose tissue composition
Measured: 3 months
immune profile
Change circulating cytokines
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2018
- Study start12 Jun 2017
- Primary completion12 Oct 2019
- Study completion25 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies 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
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefan Siebert, MBChB PhD, Principal investigator, Glasgow University and NHS GGC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03399708
- Sponsor's protocol ID
- GN16RH008
- Acronym
- IMAPA
- Status last verified
- Nov 2019
- First submitted
- 27 Nov 2017
- Last updated
- 25 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Metabolic Associations in Psoriatic Arthritis Study
- ClinicalTrials.gov ID
- NCT03399708
- Acronym / sponsor ID
- IMAPA / GN16RH008
- Conditions
- Psoriasis, Psoriatic Arthritis
- Keywords
- apremilast, PDE4 inhibition, cardiometabolic, immune profile
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Study start
- 12 Jun 2017 (actual)
- Primary completion
- 12 Oct 2019 (actual)
- Study completion
- 25 Oct 2019 (actual)
- First posted
- 16 Jan 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.
To use apremilast in clinical practice as a molecular probe to evaluate the effects of PDE4 inhibition on the cardiometabolic status and immune profile in patients with PsA and psoriasis.
Detailed description
Psoriatic arthritis (PsA) and psoriasis are characterised by immune, metabolic, and vascular dysfunction. There is an increase in Major Adverse Cardiovascular Events in people with PsA and psoriasis not explained by conventional cardiovascular risk factors. Furthermore, obesity in psoriasis is associated with increased risk of developing PsA3. Dietary interventions leading to weight loss >5% are associated with a higher rate of achievement of minimal disease activity in overweight/obese patients with PsA treated with TNF inhibitors. Phosphodiesterase 4 (PDE4) inhibition with apremilast is licensed for the treatment of PsA and psoriasis and has been noted to be associated with weight loss. There is also data from animal models to suggest a role for PDE4 in glucose metabolism. However, the exact mechanisms underlying this are unclear and warrant investigation in humans. PDE4 may help explain the link between the immune and cardiometabolic dysfunction that characterises PsA and psoriasis, with pathogenic and therapeutic implications.
This study aims to use apremilast as a clinical molecular probe to evaluate the effects of PDE4 inhibition on metabolic, vascular, and immune status in patients with PsA and psoriasis. The hypothesis is that PDE4 inhibition mediates profound and synergistic effects on immune and metabolic pathways in these conditions to improve metabolic status and normalise dysregulated immunity.
Measurement of metabolic, immunological and vascular outcomes in 60 patients (40 with PsA and 20 with psoriasis) receiving apremilast as part of their standard clinical care will be taken. A subgroup of 20 participants with PsA will also undergo more in-depth investigations including MRI of abdominal fat, subcutaneous fat biopsy, measurement of vascular endothelial function using EndoPAT and more detailed deep-immunophenotyping. Patients will be recruited from rheumatology and dermatology clinics in NHS Greater Glasgow and Clyde (primary site) and two other recruiting sites in Scotland via the Scottish Collaborative Arthritis Research network (SCAR).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with PsA and psoriasis.
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Have either a diagnosis of PsA (n=40) fulfilling the CASPAR criteria or Chronic plaque psoriasis (confirmed by dermatologist) (n=20)
- Eligible for apremilast therapy in line with the licence and SMC approval
- Able and willing to give written informed consent and comply with the requirements of the study protocol.
Key exclusion criteria (20 listed)
- History of or current autoimmune rheumatic disease other than PsA or psoriasis
- Severe renal disease (eGFR ≤30ml/min)
- Liver disease with ALT/AST >4 times ULN
- Haemoglobin ≤9 g/dl
- Inflammatory bowel disease or coeliac disease
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 |
|---|---|---|
| Apremilast 30mgApremilast will used in line with its license. This includes the standard dose titration scheme (see section 6) and then the usual maintenance dose of 30 mg twice daily orally. | Drug | – |
Primary outcome
Changes in cardiometabolic profile
Time frame: 3 months
To characterise dynamic changes in cardiometabolic profile with formal assessment at 3 months.
8 secondary outcomes
Lipids
Time frame: 6 months
NMR metabolomic profile
Time frame: 6 months
Blood pressure
Time frame: 6 months
endothelial function
Time frame: 3 months
MRI imaging
Time frame: 3 months
GLP-1 levels
Time frame: 6 months
adipose tissue
Time frame: 3 months
immune profile
Time frame: 6 months
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 25 Nov 2019.
- 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.
Stefan Siebert, MBChB PhD principal investigator
Glasgow University and NHS GGC
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 Psoriasis and Psoriatic Arthritis, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
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 4 inclusion and 20 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 25 Nov 2019. 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 United Kingdom. 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?
Changes in cardiometabolic profile (time frame: 3 months). 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 25 Nov 2019.