PsoriasisNCT01320293
Cardiovascular Effects in Psoriasis Patients Treated With Adalimumab.
A study testing Adalimumab 40 MG/0.8 ML Subcutaneous Solution [HUMIRA] in people with Psoriasis, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Severe psoriasis has been demonstrated to be associated with decreased endothelial function and an increase risk of future coronary events. Although systemic therapy with immunomodulatory agents has been shown to improve psoriatic symptoms, its effects on systemic inflammation and endothelial function are unknown. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- Adalimumab 40 MG/0.8 ML Subcutaneous Solution [HUMIRA]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Mar 2015
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Must understand and voluntarily sign an informed consent form.
- Must be male or female and age 18-55 years at time of consent.
- Must be able to adhere to the study visit schedule and other protocol requirements
- Have chronic plaque psoriasis for more than 6 months with a PASI score of 12 or greater at Baseline.
- Females of childbearing potential (FCBP)‡ must have a negative urine pregnancy test at screening (Visit 1).
- Negative PPD at Screening or 3 months earlier.
- Have not used any biologic treatment for psoriasis in the past 12 months.
Who cannot join
- Inability to provide voluntary consent
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
- Pregnant, trying to become pregnant or breastfeeding
- Prior diagnosis of coronary artery disease (CAD) or heart disease.
- Systemic fungal infection
- History of past or active mycobacterial infection with any species (including Mycobacterium tuberculosis). Latent Mycobacterium tuberculosis infection as indicated by a positive (more than 15mm induration)Purified Protein Derivative [PPD] skin test. Subjects with a positive PPD skin test and documented completion of treatment for latent TB are eligible. Subjects with a positive PPD skin test and not treated or no documentation of completion of treatment are ineligible.
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- History of recurrent bacterial infection (at least 3 major infections resulting in hospitalization and/or requiring intravenous antibiotic treatment within the past 2 years)
- Clinically significant abnormality on the chest x-ray (CXR) at screening. Chest x-rays performed within 3 months prior to start of study drug are acceptable.
- Use of any investigational medication within 4 weeks prior to start of study drug or 5 pharmacokinetic/pharmacodynamic half-lives (whichever is longer)
- History of Human Immunodeficiency Virus (HIV) infection or Hepatitis C
- Positive Hepatitis B Surface antigen at screening
- Malignancy or history of malignancy (except for treated [ie, cured] basal-cell skin carcinomas > 3 years prior to screening)
- History of any demyelinating disorder such as multiple sclerosis.
Trial locations and contacts
1 site in 1 country.
United States1 site
UNC Dermatology Clinical Trials Unit
Chapel Hill, North Carolina, 27516
About this study
Official title: Effect of Immunomodulatory Therapy With Adalimumab on Endothelial Function in Patients With Moderate to Severe Psoriasis
Severe psoriasis has been demonstrated to be associated with decreased endothelial function and an increase risk of future coronary events. Although systemic therapy with immunomodulatory agents has been shown to improve psoriatic symptoms, its effects on systemic inflammation and endothelial function are unknown.
In this study we want to assess the cardiovascular risks factors, endothelial dysfunction and inflammatory markers before and after treatment of moderate to severe psoriasis with an FDA-approved biologic agent, adalimumab (Humira).
- Conditions
- Psoriasis
- Being tested
- Adalimumab 40 MG/0.8 ML Subcutaneous Solution [HUMIRA]
- Keywords
- Moderate to Severe Chronic plaque type psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adalimumab 40 MG/0.8 ML Subcutaneous Solution [HUMIRA]Drug
Also called Humira
40mg subcutaneously, every other week for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Adalimumab 40mg | Experimental | Adalimumab 40 MG/0.8 ML Subcutaneous Solution [HUMIRA] Dose administered every other week for 6 months Receives: Drug: Adalimumab 40 MG/0.8 ML Subcutaneous Solution [HUMIRA] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change in Endothelial Function Compared to Baseline.
Percentage change in endothelial function between baseline visit and end of treatment, 6 months. Endothelial function was measured by percent change in brachial artery diameter after flow mediated dilation (FMD%).
Measured: 6 months
Secondary outcomes (2)
Changes in IL-6 Profile Compared to Baseline
IL6 average concentration in pg/ml at Baseline compared to end of treatment, 6 months.
Measured: 6 months
Changes in Adiponectin Profile Compared to Baseline
Adiponectin concentration in pg/ml measured at Baseline and end of treatment, 6 months.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionMar 2015
- Study completionMar 2015
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 University of North Carolina, Chapel HillThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- AbbVie
- Responsible party
- Principal investigator, Aida Lugo-Somolinos, MD, University of North Carolina, Chapel Hill
- Investigators
- Aida Lugo-Somolinos, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01320293
- Sponsor's protocol ID
- ABBO-0001
- Status last verified
- Oct 2016
- First submitted
- 18 Mar 2011
- Last updated
- 26 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: no plan to share data
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Immunomodulatory Therapy With Adalimumab on Endothelial Function in Patients With Moderate to Severe Psoriasis
- ClinicalTrials.gov ID
- NCT01320293
- Acronym / sponsor ID
- ABBO-0001
- Conditions
- Psoriasis
- Keywords
- Moderate to Severe Chronic plaque type psoriasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- AbbVie
- Study start
- Mar 2011
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 22 Mar 2011 (estimated)
- Results
- Posted 26 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Severe psoriasis has been demonstrated to be associated with decreased endothelial function and an increase risk of future coronary events. Although systemic therapy with immunomodulatory agents has been shown to improve psoriatic symptoms, its effects on systemic inflammation and endothelial function are unknown.
In this study we want to assess the cardiovascular risks factors, endothelial dysfunction and inflammatory markers before and after treatment of moderate to severe psoriasis with an FDA-approved biologic agent, adalimumab (Humira).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adalimumab 40mg | Experimental | Drug: Adalimumab 40 MG/0.8 ML Subcutaneous Solution [HUMIRA]Adalimumab 40 MG/0.8 ML Subcutaneous Solution [HUMIRA] Dose administered every other week for 6 months |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Must understand and voluntarily sign an informed consent form.
- Must be male or female and age 18-55 years at time of consent.
- Must be able to adhere to the study visit schedule and other protocol requirements
- Have chronic plaque psoriasis for more than 6 months with a PASI score of 12 or greater at Baseline.
- Females of childbearing potential (FCBP)‡ must have a negative urine pregnancy test at screening (Visit 1).
Key exclusion criteria (13 listed)
- Inability to provide voluntary consent
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
- Pregnant, trying to become pregnant or breastfeeding
- Prior diagnosis of coronary artery disease (CAD) or heart disease.
- Systemic fungal infection
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 |
|---|---|---|
| Adalimumab 40 MG/0.8 ML Subcutaneous Solution [HUMIRA]Also: Humira40mg subcutaneously, every other week for 6 months | Drug | Adalimumab 40mg |
Primary outcome
Percentage Change in Endothelial Function Compared to Baseline.
Time frame: 6 months
Percentage change in endothelial function between baseline visit and end of treatment, 6 months. Endothelial function was measured by percent change in brachial artery diameter after flow mediated dilation (FMD%).
2 secondary outcomes
Changes in IL-6 Profile Compared to Baseline
Time frame: 6 months
Changes in Adiponectin Profile Compared to Baseline
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. no plan to share data
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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.
Aida Lugo-Somolinos, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adalimumab 40 MG/0.8 ML Subcutaneous Solution [HUMIRA] in people with Psoriasis, run by University of North Carolina, Chapel Hill 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 7 inclusion and 13 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 26 Dec 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 26 Dec 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?
Percentage Change in Endothelial Function Compared to Baseline. (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 26 Dec 2016.