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PsoriasisPhase 4NCT00940862

Effect of Adalimumab on Vascular Inflammation in Patients With Moderate to Severe Plaque Psoriasis

A Phase 4 study testing adalimumab, UVB Phototherapy and Topical treatment in people with Psoriasis and Vascular Inflammation, run by Innovaderm Research Inc. at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study is to determine the effect of adalimumab on inflammation of blood vessels that could lead to heart attack in patients with psoriasis. Changes to the carotid artery and ascending aorta will be evaluated in patients treated with adalimumab (systemic treatment) and compared against patients treated with a… Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
adalimumab, UVB Phototherapy and Topical treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
2 sitesCanada
Study dates
Jul 2009to Aug 2011
Phase
Phase 4
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18-80 years old and capable of giving informed consent.
  • at least a 6-month history of chronic moderate to severe psoriasis and a candidate for systemic therapy.
  • BSA covered with psoriasis of at least 5 % or more at Baseline.
  • An history of coronary atherosclerosis or at least three risk factors among the following: hypertension, active smoking, diabetes mellitus, dyslipidemia, obesity, microalbuminuria, age above 55 years, and first degree relative with coronary atherosclerosis before 65 years.
  • Patient must be on a stable dose for at least 8 weeks before baseline if taking medications used to control angina, hypertension, serum lipids and any medication that can have an effect on inflammation.
  • Patient has a carotid or ascending aorta atherosclerotic plaque inflammation target-to background ratio of 1.6 or more as determined by 18-FDG uptake measured by PET scanning.
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  • Female patient is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile, or is of childbearing potential and practicing one of the following methods of birth control throughout the study and for 150 days after study completion:
  • condoms, sponge, foams, jellies, diaphragm or IUD.
  • contraceptives for three months prior to study drug administration
  • a vasectomized partner.
  • Female patient of childbearing potential must have a negative serum pregnancy test at the Screening visit.
  • Patient is judged to be in good general health as determined by the principal investigator.
  • Patient will be evaluated for latent TB infection with a PPD or a Quantiferon Gold test and CXR. Patient who demonstrates evidence of latent TB infection will only be allowed to participate in the study if they are willing to use TB prophylaxis according to Canadian guidelines
  • Patient must be able and willing to provide written informed consent and comply with the requirements of this study protocol.
  • Patient must be able and willing to self-administer SC injections or have a qualified person available to administer SC injections.

Who cannot join

  • Patient has other active skin diseases or skin infections (that may interfere with evaluation of psoriasis or with patient's safety.
  • Patient has a history of an allergic reaction or significant sensitivity to constituents of study drug, including latex.
  • Patient used any non-biological systemic therapy for the treatment of psoriasis less than 30 days before Day 0. Investigational chemical agents must be discontinued at least 30 days or five half-lives prior to the Baseline visit (whichever is longer).
  • Patient who has used any biological therapy for the treatment of psoriasis less than 3 months (90 days) before Day 0.
  • Patient is taking or requires oral or injectable corticosteroids during the study. Inhaled corticosteroids for stable medical conditions are allowed.
  • Patient has used any topical treatment for psoriasis or has used phototherapy within the last 2 weeks prior to baseline (at the exception of low strength (hydrocortisone and desonide) topical corticosteroid for the face, groin (including genitals) and inframammary areas).
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  • Patient has received Anakinra/Kineret within the last 2 weeks prior to the Baseline visit or is likely to receive Anakinra/Kineret during the course of the study.
  • Patient has a poorly controlled medical condition, such as uncontrolled diabetes, documented history of recurrent infections, unstable ischemic heart disease, congestive heart failure a left ventricular ejection fraction of less than 40%, recent stroke, chronic leg ulcer or any other condition which, in the opinion of the investigator, would put the patient at risk if participating in the study.
  • Patient had a myocardial infarction or hospitalization for a cardiac condition within the past 12 weeks.
  • Patient has a history of acute coronary syndrome, percutaneous coronary intervention, coronary artery bypass graft, or carotid revascularization within 12 weeks of baseline.
  • Patient for whom a change in medical treatment for angina, serum lipids, hypertension or any other medication that can have a significant effect on inflammation is planned for the duration of the study.
  • Patient has a history of neurologic symptoms suggestive of central nervous system demyelinating disease.
  • Patient has history of cancer or lymphoproliferative disease other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix.
  • Patient has a history of listeriosis, treated or untreated TB, persistent chronic infections, or recent active infections requiring hospitalization or treatment with intravenous anti-infectives within 30 days or oral anti-infectives within 14 days prior to the Baseline visit.
  • Patient has received any live attenuated vaccine 28 days or less before baseline.
  • Patient with hepatitis B or hepatitis C viral infection.
  • Patient with any of the following: hemoglobin = 10 g/L, white blood cell count = 3.0 X 109/L, platelet count =130 X 109/L, ALT = 2 times the upper limit of normal, AST = 2 times the upper normal limit, total bilirubin = 2 times the upper normal limit or creatinine = 150 umol/L.
  • Patient is currently using or plans to use anti-retroviral therapy at any time during the study.
  • Patient is known to have immune deficiency or is immunocompromised.
  • Female patient who is pregnant or breast-feeding or considering becoming pregnant during the study or for 150 days after the last dose of study medication.
  • Patient has a history of clinically significant drug or alcohol abuse in the last year.
  • Patient is considered by the investigator, for any reason, to be an unsuitable candidate for the study.

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • Montreal Heart Institute

    Montreal, Quebec, H1T 1C8

  • Innovaderm Research Inc

    Montreal, Quebec, H2K 4L5

Other trials in Canada

About this study

Official title: Pilot Study on the Effect of Adalimumab on Vascular Inflammation in Patients With Moderate to Severe Plaque Psoriasis

This study is to determine the effect of adalimumab on inflammation of blood vessels that could lead to heart attack in patients with psoriasis. Changes to the carotid artery and ascending aorta will be evaluated in patients treated with adalimumab (systemic treatment) and compared against patients treated with a topical treatment that does not affect the entire body.

Read the detailed description

Psoriasis and rheumatoid arthritis (RA) have been shown to be independent risk factors for myocardial infarction (MI). The risk is believed to be related in part to systemic inflammation associated with these diseases. Some studies have suggested that treatment of RA patients with anti-TNF alpha can decrease the risks of MI. However, we do not have data on the effect of anti-TNF alpha on coronary atherosclerosis. Adalimumab is probably the best anti-TNF alpha candidate to study for an effect on coronary atherosclerosis as it has more affinity for membrane bound TNF alpha than other anti-TNF alpha products such as etanercept and a higher global anti-TNF alpha activity in psoriasis patients.

This study involves a comparison of adalimumab administered sub-cutaneously with a loading dose of 80 mg followed by 40 mg at week 1 and 40 mg every other week thereafter for a total of 10 injections (two 40 mg injections at week 0 for a total dose of 80 mg, followed by single injections at weeks 1, 3, 5, 7, 9, 11, 13 and 15) with non systemic treatments for psoriasis (topical therapy and/or UVB therapy). Patients will be randomized (2:1) to either adalimumab or topical and/or UVB therapy for psoriasis.

If this pilot study shows that adalimumab reduces vascular inflammation in patients with psoriasis, a larger study could be undertaken to study the effect of adalimumab on coronary atherosclerotic plaques.

Being tested
adalimumab, UVB Phototherapy, Topical treatment
Keywords
psoriasis, vascular inflammation, coronary atherosclerosis
Medical subject headings
Psoriasis, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • adalimumabBiological

    Also called Humira

    Injection of adalimumab (80 mg followed by 40 mg at week 1 and 40 mg EOW thereafter for 15 weeks)

  • UVB PhototherapyDevice

    Also called Ultra violet light B

    This intervention can be applied alone or in combination with topical treatment. It will be performed between Day 0 and Day 112. The investigator is free to introduce or modify the topical and/or UVB regimens at any time after screening.

  • Topical treatmentOther

    This intervention can be applied alone or in combination with UVB phototherapy. It will be performed between Day 0 and Day 112. The investigator is free to introduce or modify the topical and/or UVB regimens at any time after screening. The investigator will prescribe to patients randomized in this arm a select topical product from the list:

    Calcipotriol, Calcipotriene, Dovonex, Tazorac, Tazarotene Anthralin, Corticosteroids.

Study groups in NCT00940862
Study groupRoleWhat they receive
adalimumabExperimentalA total of 20 patients will be randomized to adalimumab (80 mg followed by 40 mg at week 1 and 40 mg EOW thereafter for 15 weeks)
Receives: Biological: adalimumab
Non-systemic treatment.Active comparatorA total of 10 patients will be randomized to non systemic therapy for psoriasis (topical treatments and/or UVB phototherapy).
Receives: Device: UVB Phototherapy; Other: Topical treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The changes in the target (atherosclerotic plaque) to background (blood) ratio (TBR) from the carotid artery and ascending aorta in patients randomized to adalimumab as compared to patients randomized to standard non-systemic therapy.

    Measured: Day -10 to -1, Day 105

Secondary outcomes (4)

  1. The changes in the TBR from a coronary artery from Day 0 to Day 105 in patients randomized to adalimumab as compared to patients randomized to standard therapy.

    Measured: Day -10 to -1, Day 105.

  2. To study changes in hs C-Reactive protein levels and serum lipids levels between Day 0 and Day 112 in patients randomized to adalimumab compared to patients randomized to standard therapy.

    Measured: Day 0, 28, 56, 112

  3. To study the safety of adalimumab in patients with psoriasis and history of coronary atherosclerosis or with at least three risk factors for coronary atherosclerosis. atherosclerosis or with at least three risk factors for coronary atherosclerosis

    Measured: Day 0, 28, 56, 112, 175

  4. To study the efficacy of adalimumab in patients with psoriasis and coronary atherosclerosis or at least three risk factors. PASI will be recorded and the percentage of patients achieving PASI 75 at Day 112 will be calculated for all patients randomized.

    Measured: Day 0, 28, 56, 112

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2009 (estimated)
  2. Study startJul 2009
  3. Primary completionJun 2011
  4. Study completionAug 2011

Resources

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 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00940862
Sponsor's protocol ID
Inno-6009
Status last verified
Oct 2011
First submitted
22 Jun 2009
Last updated
28 Oct 2011
Results posted
No
Data monitoring committee
No

Publications

  • Choi J, Koo JY. Quality of life issues in psoriasis. J Am Acad Dermatol. 2003 Aug;49(2 Suppl):S57-61. doi: 10.1016/s0190-9622(03)01136-8.

    PubMed 12894127

  • Gelfand JM, Feldman SR, Stern RS, Thomas J, Rolstad T, Margolis DJ. Determinants of quality of life in patients with psoriasis: a study from the US population. J Am Acad Dermatol. 2004 Nov;51(5):704-8. doi: 10.1016/j.jaad.2004.04.014.

    PubMed 15523347

  • Weiss SC, Kimball AB, Liewehr DJ, Blauvelt A, Turner ML, Emanuel EJ. Quantifying the harmful effect of psoriasis on health-related quality of life. J Am Acad Dermatol. 2002 Oct;47(4):512-8. doi: 10.1067/mjd.2002.122755.

    PubMed 12271293

  • Tremblay JF, Bissonnette R. Topical agents for the treatment of psoriasis, past, present and future. J Cutan Med Surg. 2002 May-Jun;6(3 Suppl):8-11. doi: 10.1177/12034754020060S303. Epub 2002 Apr 30. No abstract available.

    PubMed 11976984

  • Guenther L, Langley RG, Shear NH, Bissonnette R, Ho V, Lynde C, Murray E, Papp K, Poulin Y, Zip C. Integrating biologic agents into management of moderate-to-severe psoriasis: a consensus of the Canadian Psoriasis Expert Panel. February 27, 2004. J Cutan Med Surg. 2004 Sep-Oct;8(5):321-37. doi: 10.1007/s10227-005-0035-1.

    PubMed 15868311

  • Langley RG, Ho V, Lynde C, Papp KA, Poulin Y, Shear N, Toole J, Zip C. Recommendations for incorporating biologicals into management of moderate to severe plaque psoriasis: individualized patient approaches. J Cutan Med Surg. 2006;9 Suppl 1:18-25. doi: 10.1007/s10227-006-0103-1.

    PubMed 16633860

  • Gelfand JM, Neimann AL, Shin DB, Wang X, Margolis DJ, Troxel AB. Risk of myocardial infarction in patients with psoriasis. JAMA. 2006 Oct 11;296(14):1735-41. doi: 10.1001/jama.296.14.1735.

    PubMed 17032986

  • Goodson N, Marks J, Lunt M, Symmons D. Cardiovascular admissions and mortality in an inception cohort of patients with rheumatoid arthritis with onset in the 1980s and 1990s. Ann Rheum Dis. 2005 Nov;64(11):1595-601. doi: 10.1136/ard.2004.034777. Epub 2005 Apr 20.

    PubMed 15843450

  • Maradit-Kremers H, Crowson CS, Nicola PJ, Ballman KV, Roger VL, Jacobsen SJ, Gabriel SE. Increased unrecognized coronary heart disease and sudden deaths in rheumatoid arthritis: a population-based cohort study. Arthritis Rheum. 2005 Feb;52(2):402-11. doi: 10.1002/art.20853.

    PubMed 15693010

  • Watson DJ, Rhodes T, Guess HA. All-cause mortality and vascular events among patients with rheumatoid arthritis, osteoarthritis, or no arthritis in the UK General Practice Research Database. J Rheumatol. 2003 Jun;30(6):1196-202.

    PubMed 12784389

  • van Leuven SI, Franssen R, Kastelein JJ, Levi M, Stroes ES, Tak PP. Systemic inflammation as a risk factor for atherothrombosis. Rheumatology (Oxford). 2008 Jan;47(1):3-7. doi: 10.1093/rheumatology/kem202. Epub 2007 Aug 16.

    PubMed 17702769

  • Moubayed SP, Heinonen TM, Tardif JC. Anti-inflammatory drugs and atherosclerosis. Curr Opin Lipidol. 2007 Dec;18(6):638-44. doi: 10.1097/MOL.0b013e3282f0ee11.

    PubMed 17993809

  • Dixon WG, Symmons DP. What effects might anti-TNFalpha treatment be expected to have on cardiovascular morbidity and mortality in rheumatoid arthritis? A review of the role of TNFalpha in cardiovascular pathophysiology. Ann Rheum Dis. 2007 Sep;66(9):1132-6. doi: 10.1136/ard.2006.063867. Epub 2007 Jan 24.

    PubMed 17251223

  • Dixon WG, Watson KD, Lunt M, Hyrich KL; British Society for Rheumatology Biologics Register Control Centre Consortium; Silman AJ, Symmons DP; British Society for Rheumatology Biologics Register. Reduction in the incidence of myocardial infarction in patients with rheumatoid arthritis who respond to anti-tumor necrosis factor alpha therapy: results from the British Society for Rheumatology Biologics Register. Arthritis Rheum. 2007 Sep;56(9):2905-12. doi: 10.1002/art.22809.

    PubMed 17763428

  • Jacobsson LT, Turesson C, Gulfe A, Kapetanovic MC, Petersson IF, Saxne T, Geborek P. Treatment with tumor necrosis factor blockers is associated with a lower incidence of first cardiovascular events in patients with rheumatoid arthritis. J Rheumatol. 2005 Jul;32(7):1213-8.

    PubMed 15996054

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing adalimumab, UVB Phototherapy and Topical treatment in people with Psoriasis and Vascular Inflammation, run by Innovaderm Research Inc. at 2 sites in Canada.

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 15 inclusion and 22 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 28 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

The changes in the target (atherosclerotic plaque) to background (blood) ratio (TBR) from the carotid artery and ascending aorta in patients randomized to adalimumab as compared to patients randomized to standard non-systemic therapy. (time frame: Day -10 to -1, Day 105). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00940862, which also lists 27 linked publications.

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 28 Oct 2011.

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