PsoriasisMMAPPSNCT01522742
Monitoring and Modifying Atherosclerosis in Psoriasis Patients Study
An observational study of Psoriasis, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The main aims of this study are to determine whether: a) psoriasis patients with or without arthritis have more cardiovascular inflammation than healthy subjects and b)3 months of etanercept (enbrel) therapy (prescribed to psoriasis patients with or without arthritis by their treating clinicians) will decrease… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Jan 2016
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects with moderate-to-severe psoriasis with or without arthritis will be recruited primarily from dermatology and rheumatology clinics in the eastern Massachusetts area.
Who may be able to join
- -men and women age 18-80 with moderate-to-severe psoriasis (with or without arthritis) newly initiating biologic therapy with etanercept (enbrel) 50 mg once or twice weekly
- -men and women age 18-80 without psoriasis
Who cannot join
- pregnancy or breastfeeding
- women of child-bearing potential refusing to practice abstinence or to use a reliable barrier form of birth control including condoms, IUD, or diaphragm
- history of acute coronary syndrome or coronary artery stenting or surgery, or significant autoimmune/inflammatory disease other than psoriasis or a related psoriatic condition
- previous therapy for psoriasis with a biologic agent within the past 4 months
- new initiation of a statin or antihyperglycemic agent within the past 3 months
- screening hemoglobin < 11
Show all 21Show fewer
- conditions which would make MDCT coronary angiography/ cardiac FDG-PET protocol unsafe or unfeasible including: significant renal dysfunction with an eGFR by Cockcroft-Gault equation of <60 ml/min, contrast dye allergy, contraindication to beta-blockers (e.g. severe asthma, hypotension, or heart block), or contraindication to nitroglycerin (uninterruptable administration of phosphodiesterase inhibitors), body weight greater than 320 lbs (PET scanner table limitation)
- report by subject of any significant radiation exposure over the course of the year prior to enrollment; significant exposure is defined as:
- more than 2 myocardial perfusion studies within the past 12 months
- more than 2 CT angiograms within the past 12 months
- concurrent enrollment in a clinical trial judged by the investigator to introduce concerns about safety or confounding
- FOR HEALTHY CONTROL SUBJECTS
- pregnancy or breastfeeding
- women of child-bearing potential refusing to practice abstinence or to use a reliable barrier form of birth control including condoms, IUD, or diaphragm
- history of acute coronary syndrome or coronary artery stenting or surgery, or significant autoimmune/inflammatory disease
- screening hemoglobin < 11
- conditions which would make MDCT coronary angiography/ cardiac FDG-PET protocol unsafe or unfeasible including: significant renal dysfunction with an estimated creatinine clearance by Cockcroft-Gault equation of <60 ml/min, contrast dye allergy, contraindication to beta-blockers (e.g. severe asthma, hypotension, or heart block), or contraindication to nitroglycerin (e.g. continuous administration of phosphodiesterase inhibitors), body weight greater than 320 lbs PET scanner table limitation)
- report by subject of any significant radiation exposure over the course of the year prior to enrollment; significant exposure is defined as:
- more than 2 myocardial perfusion studies within the past 12 months
- more than 2 CT angiograms within the past 12 months
- concurrent enrollment in a clinical trial judged by the investigator to introduce concerns about safety or confounding
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
The main aims of this study are to determine whether: a) psoriasis patients with or without arthritis have more cardiovascular inflammation than healthy subjects and b)3 months of etanercept (enbrel) therapy (prescribed to psoriasis patients with or without arthritis by their treating clinicians) will decrease cardiovascular inflammation.
Read the detailed description
Psoriasis is a common disease characterized by skin lesions and systemic inflammation with or without arthritis. Patients with psoriasis have a higher risk of cardiovascular disease than healthy subjects, and this may be related in part to the inflammatory nature of their disease. This study is intended to help provide explanations for the increased cardiovascular disease risk in psoriasis and to assess whether this risk can be reduced by biologic anti-inflammatory therapies prescribed to resolve skin lesions and arthritis.
- Conditions
- Psoriasis
- Keywords
- psoriasis, cardiovascular disease risk, atherosclerosis, etanercept (enbrel)
- Medical subject headings
- Psoriasis, Atherosclerosis
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 |
|---|---|---|
| Healthy control subjects | Healthy control subjects matched to psoriasis patients on traditional cardiovascular risk factors will be studied at baseline. | |
| Psoriasis patients starting etanercept | Patients with moderate to severe psoriasis with or without arthritis who are about to be started on etanercept (enbrel) by their treating clinicians will be studied at baseline and 3 months after etanercept therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aortic/coronary target to background ratio (TBR) on cardiac FDG-PET.
Degree of aortic/coronary atherosclerotic plaque inflammation assessed via cardiac FDG-PET as target to background ratio (TBR) of the standardized uptake value (SUV).
Measured: Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
Secondary outcomes (7)
Aortic/coronary atherosclerotic plaque burden on MDCT coronary angiography.
Burden of aortic/coronary atherosclerotic plaque as measured by MDCT coronary angiography.
Measured: Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
Aortic/coronary atherosclerotic plaque morphology on MDCT coronary angiography.
Morphology of the aortic/coronary atherosclerotic plaque (e.g. calcification score, vulnerability characteristics) as measured by MDCT coronary angiography.
Measured: Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
Endothelial function as measured by flow-mediated vasodilation.
Measured: Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
Oral glucose tolerance.
Blood sugar and insulin levels during a standard 2-hour oral glucose tolerance test.
Measured: Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
Lipid and lipoprotein levels.
Levels of total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, apolipoprotein A1, apolipoprotein B, apolipoprotein C-II, apolipoprotein C-III, and apolipoprotein E.
Measured: Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
Inflammatory biomarker levels.
Levels of inflammatory biomarkers including but not limited to high-sensitivity C-reactive protein, interleukin-6, and TNF-alpha.
Measured: Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
Body fat distribution.
Measurements of height, weight, waist-to-hip ratio, leg circumference, arm circumference, and neck circumference. Determinations by whole body DEXA scanning of the total body and regional percent fat and lean body mass. Determination by single-slice abdominal computed tomography of total fat area, visceral adipose tissue, and subcutaneous adipose tissue.
Measured: Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionJan 2016
- Study completionJan 2016
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.
- More trials run by Massachusetts General HospitalThe 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
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Immunex Corporation
- Responsible party
- Principal investigator, Steven K. Grinspoon, MD, Massachusetts General Hospital
- Investigators
- Steven K Grinspoon, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01522742
- Sponsor's protocol ID
- 2011P-000557
- Acronym
- MMAPPS
- Status last verified
- Mar 2017
- First submitted
- 29 Dec 2011
- Last updated
- 17 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring and Modifying Atherosclerosis in Psoriasis Patients Study
- ClinicalTrials.gov ID
- NCT01522742
- Acronym / sponsor ID
- MMAPPS / 2011P-000557
- Conditions
- Psoriasis
- Keywords
- psoriasis, cardiovascular disease risk, atherosclerosis, etanercept (enbrel)
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Immunex Corporation
- Study start
- Feb 2012
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 1 Feb 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 main aims of this study are to determine whether: a) psoriasis patients with or without arthritis have more cardiovascular inflammation than healthy subjects and b)3 months of etanercept (enbrel) therapy (prescribed to psoriasis patients with or without arthritis by their treating clinicians) will decrease cardiovascular inflammation.
Detailed description
Psoriasis is a common disease characterized by skin lesions and systemic inflammation with or without arthritis. Patients with psoriasis have a higher risk of cardiovascular disease than healthy subjects, and this may be related in part to the inflammatory nature of their disease. This study is intended to help provide explanations for the increased cardiovascular disease risk in psoriasis and to assess whether this risk can be reduced by biologic anti-inflammatory therapies prescribed to resolve skin lesions and arthritis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy control subjects | – | –Healthy control subjects matched to psoriasis patients on traditional cardiovascular risk factors will be studied at baseline. |
| Psoriasis patients starting etanercept | – | –Patients with moderate to severe psoriasis with or without arthritis who are about to be started on etanercept (enbrel) by their treating clinicians will be studied at baseline and 3 months after etanercept therapy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with moderate-to-severe psoriasis with or without arthritis will be recruited primarily from dermatology and rheumatology clinics in the eastern Massachusetts area.
Key inclusion criteria (2 listed)
- -men and women age 18-80 with moderate-to-severe psoriasis (with or without arthritis) newly initiating biologic therapy with etanercept (enbrel) 50 mg once or twice weekly
- -men and women age 18-80 without psoriasis
Key exclusion criteria (21 listed)
- pregnancy or breastfeeding
- women of child-bearing potential refusing to practice abstinence or to use a reliable barrier form of birth control including condoms, IUD, or diaphragm
- history of acute coronary syndrome or coronary artery stenting or surgery, or significant autoimmune/inflammatory disease other than psoriasis or a related psoriatic condition
- previous therapy for psoriasis with a biologic agent within the past 4 months
- new initiation of a statin or antihyperglycemic agent within the past 3 months
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
Aortic/coronary target to background ratio (TBR) on cardiac FDG-PET.
Time frame: Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
Degree of aortic/coronary atherosclerotic plaque inflammation assessed via cardiac FDG-PET as target to background ratio (TBR) of the standardized uptake value (SUV).
7 secondary outcomes
Aortic/coronary atherosclerotic plaque burden on MDCT coronary angiography.
Time frame: Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
Aortic/coronary atherosclerotic plaque morphology on MDCT coronary angiography.
Time frame: Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
Endothelial function as measured by flow-mediated vasodilation.
Time frame: Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
Oral glucose tolerance.
Time frame: Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
Lipid and lipoprotein levels.
Time frame: Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
Inflammatory biomarker levels.
Time frame: Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
Body fat distribution.
Time frame: Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2017.
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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.
Steven K Grinspoon, MD principal investigator
Massachusetts General Hospital
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, run by Massachusetts General Hospital at 1 site in United States.
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 21 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 17 Mar 2017. 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 States. 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. 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?
Aortic/coronary target to background ratio (TBR) on cardiac FDG-PET. (time frame: Baseline in all subjects and change from baseline to 3 months in psoriasis cohort starting etanercept (enbrel).). 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 Mar 2017.