PsoriasisNCT00477191
Effects of TNF-alpha Antagonism (Etanercept) in Patients With the Metabolic Syndrome and Psoriasis
A study testing Etanercept in people with Psoriasis and Metabolic Syndrome, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
People with psoriasis have significantly higher rates of obesity, diabetes, heart failure and high blood pressure than the general public. The purpose of this study is to determine how substances produced in the fat (inflammatory markers) relate to the risk of heart disease in people with the metabolic syndrome and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis, Metabolic Syndrome, Hyperlipidemia
- What is being tested?
- Etanercept
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Dec 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Age > 18
- Subject willing and able to give informed consent.
- Adult patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
- PASI > 10 and BSA affected with psoriasis > 10.
- Abdominal obesity defined by waist hip ratio > 0.90 for men and > 0.85 for women and BMI ³ 30 kg/m2
Who cannot join
- On insulin or other diabetes (anti-hyperglycemic) medication
- Congestive Heart Failure
- Heart Attack, Stroke or Transient Ischemic Attack in last 3 months
- Unstable angina
- Pulmonary disease requiring oxygen
- SLE, optic neuritis, transverse myelitis, epilepsy
Show all 18Show fewer
- Positive PPD
- Scheduled for upcoming surgery
- Known immunosuppression (for example, HIV)
- Known autoimmune disease
- Hepatitis B or Hepatitis C
- Pregnant or nursing
- Renal insufficiency (Creatinine >1.5)
- Latex allergy
- Use of live vaccination in past 90 days
- Organ transplantation
- History of severe infection
- History of malignancy (except cured non-melanoma skin cancer)
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
People with psoriasis have significantly higher rates of obesity, diabetes, heart failure and high blood pressure than the general public. The purpose of this study is to determine how substances produced in the fat (inflammatory markers) relate to the risk of heart disease in people with the metabolic syndrome and psoriasis. People with metabolic syndrome have insulin resistance, increased waist size, high blood pressure, or high cholesterol.
Read the detailed description
People with psoriasis have significantly higher rates of obesity, diabetes, heart failure and high blood pressure than the general public. The purpose of this study is to determine how substances produced in the fat (inflammatory markers) relate to the risk of heart disease in people with the metabolic syndrome and psoriasis. People with metabolic syndrome have insulin resistance, increased waist size, high blood pressure, or high cholesterol. Insulin resistance means that the body does not respond well to the insulin in your blood. Therefore, both blood levels of insulin and glucose (sugar) are high.
This causes inflammation (irritation) in the body. Inflammation can cause an unhealthy response in your body and blood vessels, and can lead to blockages in the heart and other vessels.
TNF-alpha is a substance made by fat and inflammatory cells that helps cause inflammatory reactions. TNF-alpha is thought to be important in causing psoriasis. The drug Etanercept blocks TNF-alpha's actions, and has been approved by the Food and Drug Administration (FDA) for the treatment of psoriasis. We think that Etanercept may also reduce the inflammation associated with metabolic syndrome and decrease the risk of heart disease. All subjects in this study will receive etanercept.
- Conditions
- Psoriasis, Metabolic Syndrome, Hyperlipidemia, Obesity, Hypertension
- Being tested
- Etanercept
- Keywords
- psoriasis, metabolic syndrome, Syndrome X, diabetes, insulin resistance, obesity, hypertension, hyperlipidemia, hypercholesterolemia
- Medical subject headings
- Psoriasis, Metabolic Syndrome, Hyperlipidemias, Obesity, Hypertension, Microvascular Angina, Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtanerceptDrug
Also called Enbrel
TNF-alpha antagonist 50 mg twice a week x 3 mos and the 50 mg once a week for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Etanercept | Experimental | Etanercept Receives: Drug: Etanercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in CRP Levels From Baseline to 6 Months of Treatment in Subjects With Psoriasis and Metabolic Syndrome
Analyzing the difference in C reactive protein levels from baseline to month 6 in subjects with Psoriasis and Metabolic Syndrome
Measured: 6 months
Secondary outcomes (3)
Change in Plasma Glucose in Subjects With Psoriasis and Metabolic Syndrome
Analyzing the difference in plasma glucose in subjects with Psoriasis and Metabolic Syndrome between baseline and month 6.
Measured: 6 months
Change of Endothelial Function by Measurement of Flow-mediated Vasodilation Using the Reactive Hyperemia Index (RHI) in 6 Months
Reactive hyperemia index (RHI) is a measure of endothelial dysfunction using noninvasive peripheral arterial tonometry (PAT). It is a ratio of the post-to-pre occlusion PAT amplitude of the tested arm, divided by the post -to-pre occlusion ratio of the control arm. RHI less than 1.67 is considered sign of endothelial dysfunction. The possible range of scores is 1 to 3 and a lower score has a worse outcome.
Measured: 6 months
Change in the Safety and Tolerability of Etanercept in Patients With Psoriasis and Metabolic Syndrome Over a 6-month Period.
Analyzing the safety and tolerability of Etanercept which is being measured through the number of adverse events related to Entanercept over a 6-month period.
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 posted22 May 2007 (estimated)
- Study startMay 2007
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: Difficulty in recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Amgen
- Responsible party
- Principal investigator, Alexandra Kimball, Massachusetts General Hospital
- Investigators
- Alexandra B Kimball, MD, MPH, Principal investigator, Massachusetts General Hospital, Brigham & Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00477191
- Sponsor's protocol ID
- 2007-P-000494
- Status last verified
- Apr 2016
- First submitted
- 18 May 2007
- Last updated
- 16 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of TNF-alpha Antagonism (Etanercept) in Patients With the Metabolic Syndrome and Psoriasis
- ClinicalTrials.gov ID
- NCT00477191
- Acronym / sponsor ID
- 2007-P-000494
- Conditions
- Psoriasis, Metabolic Syndrome, Hyperlipidemia, Obesity, Hypertension
- Keywords
- psoriasis, metabolic syndrome, Syndrome X, diabetes, insulin resistance, obesity, hypertension, hyperlipidemia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in recruitment.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Amgen
- Study start
- May 2007
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 22 May 2007 (estimated)
- Results
- Posted 16 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
People with psoriasis have significantly higher rates of obesity, diabetes, heart failure and high blood pressure than the general public. The purpose of this study is to determine how substances produced in the fat (inflammatory markers) relate to the risk of heart disease in people with the metabolic syndrome and psoriasis. People with metabolic syndrome have insulin resistance, increased waist size, high blood pressure, or high cholesterol.
Detailed description
People with psoriasis have significantly higher rates of obesity, diabetes, heart failure and high blood pressure than the general public. The purpose of this study is to determine how substances produced in the fat (inflammatory markers) relate to the risk of heart disease in people with the metabolic syndrome and psoriasis. People with metabolic syndrome have insulin resistance, increased waist size, high blood pressure, or high cholesterol. Insulin resistance means that the body does not respond well to the insulin in your blood. Therefore, both blood levels of insulin and glucose (sugar) are high.
This causes inflammation (irritation) in the body. Inflammation can cause an unhealthy response in your body and blood vessels, and can lead to blockages in the heart and other vessels.
TNF-alpha is a substance made by fat and inflammatory cells that helps cause inflammatory reactions. TNF-alpha is thought to be important in causing psoriasis. The drug Etanercept blocks TNF-alpha's actions, and has been approved by the Food and Drug Administration (FDA) for the treatment of psoriasis. We think that Etanercept may also reduce the inflammation associated with metabolic syndrome and decrease the risk of heart disease. All subjects in this study will receive etanercept.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Etanercept | Experimental | Drug: EtanerceptEtanercept |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 18
- Subject willing and able to give informed consent.
- Adult patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
- PASI > 10 and BSA affected with psoriasis > 10.
- Abdominal obesity defined by waist hip ratio > 0.90 for men and > 0.85 for women and BMI ³ 30 kg/m2
Key exclusion criteria (18 listed)
- On insulin or other diabetes (anti-hyperglycemic) medication
- Congestive Heart Failure
- Heart Attack, Stroke or Transient Ischemic Attack in last 3 months
- Unstable angina
- Pulmonary disease requiring oxygen
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 |
|---|---|---|
| EtanerceptAlso: EnbrelTNF-alpha antagonist 50 mg twice a week x 3 mos and the 50 mg once a week for 3 months. | Drug | Etanercept |
Primary outcome
Change in CRP Levels From Baseline to 6 Months of Treatment in Subjects With Psoriasis and Metabolic Syndrome
Time frame: 6 months
Analyzing the difference in C reactive protein levels from baseline to month 6 in subjects with Psoriasis and Metabolic Syndrome
3 secondary outcomes
Change in Plasma Glucose in Subjects With Psoriasis and Metabolic Syndrome
Time frame: 6 months
Change of Endothelial Function by Measurement of Flow-mediated Vasodilation Using the Reactive Hyperemia Index (RHI) in 6 Months
Time frame: 6 months
Change in the Safety and Tolerability of Etanercept in Patients With Psoriasis and Metabolic Syndrome Over a 6-month Period.
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Alexandra B Kimball, MD, MPH principal investigator
Massachusetts General Hospital, Brigham & Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Etanercept in people with Psoriasis and Metabolic Syndrome, 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 5 inclusion and 18 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 16 May 2016. 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?
Yes. Results are posted in the registry (first posted 16 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in CRP Levels From Baseline to 6 Months of Treatment in Subjects With Psoriasis and Metabolic Syndrome (time frame: 6 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 16 May 2016.