PsoriasisPhase 4NCT01722214

Trial on the Effect of Adalimumab on Vascular Inflammation in Patients With Psoriasis

A Phase 4 study testing Adalimumab in people with Psoriasis and Vascular Inflammation, run by Innovaderm Research Inc. at 5 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 a double-blinded randomized multicenter placebo controlled trial to determine the effect of adalimumab on vascular inflammation (ascending aorta and carotides) in patients with moderate to severe psoriasis. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Psoriasis, Vascular Inflammation, Coronary Atherosclerosis
What is being tested?: Adalimumab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 107 participants
Where: 5 sitesCanada
Study dates: Nov 2012to Jan 2016
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

Patient has plaque psoriasis. Patient has at least a 6 month history of plaque psoriasis.Patient has a Body Surface Area (BSA) covered with psoriasis of 5% or more at Day 0.
Patient is a candidate for systemic therapy. Patient is male or female, 18 to 80 years of age at time of consent. Patient's weight at screening is a maximum of 180 kg. Patient using medication to control angina, hypertension, serum lipids and any medication that can have an effect on inflammation must be on a stable dose for at least 8 weeks before Day 0.
Patient has an ascending aorta atherosclerotic plaque inflammation target-to-background ratio of 1.6 or more as determined by 18-FDG uptake measured by PET scanning.
Patient or patient's partner has been in a menopausal state for at least a year, is surgically sterile (hysterectomy, bilateral oophorectomy, tubal ligation or vasectomy), is clinically diagnosed infertile, has a same-sex partner, is abstinent, or is willing to use effective contraceptive method for at least 30 days before Day 0 and at least 6 months after the last study drug administration. Effective contraceptive methods are:
Barrier methods such as condom, sponge or diaphragm combined with spermicide in foam, gel or cream;
Hormonal contraception (oral, intramuscular, implant or transdermal) which include Depo-Provera, Evra and Nuvaring;

Show all 11Show fewer

Intrauterine device (IUD); Female patients 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 based upon the results of medical history, laboratory profile, physical examination, and CXR performed at Screening.
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 (either PPD more than or equal to 5 mm of induration or positive Quantiferon Gold, irrespective of Bacillus Calmette-Guerin (BCG) vaccination status and negative CXR findings for active TB, and/or suspicious CXR findings) will not be allowed to participate in the study.
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 spontaneously improving or rapidly deteriorating plaque psoriasis. Patient has other active infections (bacterial, fungal or viral) or skin diseases or skin infections (bacterial, fungal, or viral) 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 (a component of the pre-filled syringe).
Patient has used a non-biological systemic therapy for the treatment of psoriasis less than 30 days before Day 0.
Patient has used an investigational chemical or biological agent less than 30 days or 5 half-lives prior to the Day 0 visit (whichever is longer).
Patient has used a biological therapy for the treatment of psoriasis less than 90 days before day 0.
Patient has used a systemic immnosuppressor (eg. Azathioprine, 6-mercaptopurine) less than 30 days before Day 0.

Show all 22Show fewer

Patient is taking or requires oral or injectable corticosteroids during the study. Inhaled corticosteroids for stable medical conditions are allowed.
Patient has used a topical treatment for psoriasis or has used phototherapy within the last 2 weeks prior to Day 0 (at the exception of low potency topical corticosteroids for groin, genitals, face, inflammatory area, palms and soles).
Patient has received Anakinra/Kineret within the last 2 weeks prior to the Day 0 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, class III or IV (New York Heart Association Functional Classification; NYHA) congestive heart failure, an ejection fraction of less than 30%, recent stroke (within the past 3 months), 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 has had a myocardial infarction or has been hospitalized for a cardiac condition within the past 12 weeks.
Patient has a history of acute coronary syndrome, percutaneous coronary intervention, coronary artery bypass graft, carotid endarterectomy, stent installation or carotid revascularization within 12 weeks of Day 0.
Patient has had a percutaneous coronary intervention in the past 12 months. Patient plans for a change in medical treatment for angina, serum lipids, hypertension or any other medication that can have a significant effect on inflammation during the course of the study.
Patient has history of neurologic symptoms suggestive of central nervous system (CNS) demyelinating disease (e.g. optic neuritis, visual disturbance, gait disorder/ataxia, facial paresis, apraxia).
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 Tuberculosis (TB), persistent chronic infections, or recent active infections requiring hospitalization or treatment with intravenous anti-infectives within 30 days prior to the Day 0 visit or oral anti-infectives within 14 days prior to the Day 0 visit.
Patient has received a live attenuated vaccine 28 days or less before Day 0 or plan to receive a live attenuated vaccine during the study and up to 4 months after the last study drug administration..
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 ≥ 3 times the upper normal limit, total bilirubin ≥ 2 times the upper normal limit or creatinine ≥ 150 µmol/L.
Patient currently uses 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 6 months after the last dose of study medication.
Patient has a history of clinically significant drug or alcohol abuse in the last year.
Patient who plans to travel in an area where tuberculosis is endemic during the study and up to 4 months after the last study drug administration.
Patient is considered by the investigator, for any reason, to be an unsuitable candidate for the study.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Canada5 sites

Lynderm Research Inc.
Markham, Ontario, L3P 1A8
Montreal Healt Institute
Montreal, Quebec, H1T 1C8
Innovaderm Research Inc
Montreal, Quebec, H2K 4L5
Clinique Médicale Dr Isabelle Delorme
Saint-Hyacinthe, Quebec, J2S 6L6
Windsor Clinical Research Inc.
Windsor, Ontario, N8W 5L7

Other trials in Canada

About this study

Official title: Randomized Multicenter Placebo-controlled Trial on the Effect of Adalumumab on Vascular Inflammation in Patient With Moderate to Severe Psoriasis

Read the detailed description

Patients with moderate to severe psoriasis will be included in this multicenter, double-blind, placebo controlled study. Patients will be randomized (1:1) at Day 0 to receive either adalimumab or placebo. Adalimumab will be administered sub-cutaneously as described in the Canadian product monograph (80mg followed by 40mg at Week 1 and 40mg every other week). At Week 16, all patients will receive two injections of blinded study products. Patients randomized to the placebo group will receive two injections of adalimumab (2 x 40 mg) and patients randomized to adalimumab will receive two injections of placebo. As of Week 17, patients randomized to the placebo group will receive 40 mg adalimumab every other week until Week 67. Patients randomized to the adalimumab group will continue to receive adalimumab 40mg every other week until Week 51.

Efficacy will be assessed with 18-FluoroDeoxyGlucose Positron Emission Tomography (FDG-PET) scan and carotid MRI at baseline, Week 16 and Week 52 (or Week 68 for patients randomized to placebo).

Safety will be assessed with physical examinations, vital signs, adverse events collection, routine laboratory examinations, pregnancy test, hepatitis B and C serology (screening), Purified Protein Derivative (PPD) or Quantiferon Gold (screening) and Chest X-Ray (CXR) (screening).

Conditions: Psoriasis, Vascular Inflammation, Coronary Atherosclerosis
Being tested: Adalimumab, Placebo
Keywords: Psoriasis, Vascular Inflammation, Coronary Atherosclerosis, Ascending aorta, Pet scan, MRI
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 52 weeks). For Adalimibab group and Placebo group.
PlaceboOther
Injection of placebo that is physicaly identical to adalimumab without the active ingredient at identical intervals.

Study groups in NCT01722214
Study group	Role	What they receive
Group Adalimumab	Experimental	A total of 53 patients with moderate to severe psoriasis will randomized in the adalimumab group. At Day 0 patients will receive adalimumab. It will be administered sub-cutaneously as described in the Canadian product monograph (80mg followed by 40mg at Week 1 and 40mg every other week). At Week 16, all patients will received two injections of placebo. As of Week 17, patients randomized to the adalimumab group will receive 40 mg adalimumab every other week until Week 51. Receives: Biological: Adalimumab
Placebo Group	Placebo comparator	A total of 53 patients with moderate to severe psoriasis will be randomized in the placebo group. At Day 0 these patients will receive the placebo. It will be administered sub-cutaneously as described in the Canadian product monograph of adalimumab. At Week 16, all these patients will received two injections of adalimumab. As of Week 17, patients randomized to the placebo group will receive 40 mg adalimumab every other week until Week 67. Receives: Biological: Adalimumab; Other: Placebo

What is being measured

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

Change from baseline in the target (atherosclerotic plaque) to background (blood) ratio (TBR) from the ascending aorta at Week 16 for patients randomized to adalimumab as compared to patients randomized to placebo
Measured: Baseline, Week 16 and Week 52 or 68

Secondary outcomes (11)

Change from baseline in the TBR from the mean of both carotid arteries at Week 16 for patients randomized to adalimumab as compared to patients randomized to placebo
Measured: Baseline, Week 16 and Week 52 or 68
Change from baseline in the TBR from the ascending aorta 52 weeks after the first dose of adalimumab
Measured: Baseline and Week 52 or 68
Change from baseline in the TBR from the mean of both carotid arteries 52 weeks after the first dose of adalimumab
Measured: Baseline and Week 52 or 68
Change from baseline in carotid wall area at Week 16 as measured by MRI for patients randomized to adalimumab as compared to patients randomized to placebo
Measured: Baseline and Week 16
Change from baseline in carotid wall area as measured by Magnetic Resonance Imaging (MRI) 52 weeks after the first dose of adalimumab
Measured: Baseline and Week 52 or 68
Change from baseline in hsCRP at Week 16 for patients randomized to adalimumab as compared to patients randomized to placebo
Measured: Baseline and Week 16
Change from baseline in serum lipids (total cholesterol, LDL- calc, HDL cholesterol, triglycerides) at Week 16 for patients randomized to adalimumab as compared to patients randomized to placebo
Measured: Baseline, Week 16
Correlation between change from baseline in TBR from the ascending aorta at Week 16 and change from baseline in PASI at Week 16
Measured: Baseline and Week 16
Correlation between change from baseline in PASI at Week 16 and change in hsCRP at Week 16
Measured: Baseline and week 16
Correlation between change from baseline in TBR from the ascending aorta at Week 16 and change from baseline in hsCRP at Week 16
Measured: Baseline and Week 16
Correlation between change from baseline in TBR at Week 16 from the ascending aorta and change from baseline in skin inflammation as measured by PET-Scan at Week 16
Measured: Baseline and Week 16

Timeline

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

Nov 2012Jan 2016

First posted6 Nov 2012 (estimated)
Study startNov 2012
Primary completionDec 2015
Study completionJan 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (19)Papers the sponsor has linked to this study.
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: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 107 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01722214
Sponsor's protocol ID: Inno-6025
Status last verified: Sep 2016
First submitted: 2 Nov 2012
Last updated: 9 Sep 2016
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

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
Gelfand JM, Dommasch ED, Shin DB, Azfar RS, Kurd SK, Wang X, Troxel AB. The risk of stroke in patients with psoriasis. J Invest Dermatol. 2009 Oct;129(10):2411-8. doi: 10.1038/jid.2009.112. Epub 2009 May 21.
PubMed 19458634
Prodanovich S, Kirsner RS, Kravetz JD, Ma F, Martinez L, Federman DG. Association of psoriasis with coronary artery, cerebrovascular, and peripheral vascular diseases and mortality. Arch Dermatol. 2009 Jun;145(6):700-3. doi: 10.1001/archdermatol.2009.94.
PubMed 19528427
Miyasaka Y, Barnes ME, Petersen RC, Cha SS, Bailey KR, Gersh BJ, Casaclang-Verzosa G, Abhayaratna WP, Seward JB, Iwasaka T, Tsang TS. Risk of dementia in stroke-free patients diagnosed with atrial fibrillation: data from a community-based cohort. Eur Heart J. 2007 Aug;28(16):1962-7. doi: 10.1093/eurheartj/ehm012. Epub 2007 Apr 25.
PubMed 17459900
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
Mehta NN, Yu Y, Saboury B, Foroughi N, Krishnamoorthy P, Raper A, Baer A, Antigua J, Van Voorhees AS, Torigian DA, Alavi A, Gelfand JM. Systemic and vascular inflammation in patients with moderate to severe psoriasis as measured by [18F]-fluorodeoxyglucose positron emission tomography-computed tomography (FDG-PET/CT): a pilot study. Arch Dermatol. 2011 Sep;147(9):1031-9. doi: 10.1001/archdermatol.2011.119. Epub 2011 May 16.
PubMed 21576552
Hansson GK. Inflammation, atherosclerosis, and coronary artery disease. N Engl J Med. 2005 Apr 21;352(16):1685-95. doi: 10.1056/NEJMra043430. No abstract available.
PubMed 15843671
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
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
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
Turesson C, McClelland RL, Christianson TJ, Matteson EL. Severe extra-articular disease manifestations are associated with an increased risk of first ever cardiovascular events in patients with rheumatoid arthritis. Ann Rheum Dis. 2007 Jan;66(1):70-5. doi: 10.1136/ard.2006.052506. Epub 2006 Jul 28.
PubMed 16877533
Wu F. The effect of tumor necrosis factor-alfa inhibitors on the risk of myocardial infarction in patients with psoriasis. E-poster session presented at the 69th American Academy of Dermatology, Abstract P400; 4-8 Feb 2011; New Orleans, USA.
Davidovici BB, Sattar N, Prinz J, Puig L, Emery P, Barker JN, van de Kerkhof P, Stahle M, Nestle FO, Girolomoni G, Krueger JG. Psoriasis and systemic inflammatory diseases: potential mechanistic links between skin disease and co-morbid conditions. J Invest Dermatol. 2010 Jul;130(7):1785-96. doi: 10.1038/jid.2010.103. Epub 2010 May 6.
PubMed 20445552
Ko H-S, M.D. Medical Officer, Division of Dermatologic and Dental Drug Products, Center for Drug Evaluation and Research, Food and Drug Administration, Bethesda MD. Clinical Design for Psoriasis [presentation]. Dermatologic and Ophthalmic Drugs Advisory Committee 49th Meeting Open Session (Volume II); Gaithersburg, MD. 1998 March 20.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Multicenter Placebo-controlled Trial on the Effect of Adalumumab on Vascular Inflammation in Patient With Moderate to Severe Psoriasis
ClinicalTrials.gov ID: NCT01722214
Acronym / sponsor ID: Inno-6025
Conditions: Psoriasis, Vascular Inflammation, Coronary Atherosclerosis
Keywords: Psoriasis, Vascular Inflammation, Coronary Atherosclerosis, Ascending aorta, Pet scan, MRI
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 107 participants (actual)
Lead sponsor: Innovaderm Research Inc.University, hospital or other
Collaborators: Abbott, Montreal Heart Institute
Study start: Nov 2012
Primary completion: Dec 2015 (actual)
Study completion: Jan 2016 (actual)
First posted: 6 Nov 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.

Detailed description

Efficacy will be assessed with 18-FluoroDeoxyGlucose Positron Emission Tomography (FDG-PET) scan and carotid MRI at baseline, Week 16 and Week 52 (or Week 68 for patients randomized to placebo).

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Group Adalimumab	Experimental	Biological: AdalimumabA total of 53 patients with moderate to severe psoriasis will randomized in the adalimumab group. At Day 0 patients will receive adalimumab. It will be administered sub-cutaneously as described in the Canadian product monograph (80mg followed by 40mg at Week 1 and 40mg every other week). At Week 16, all patients will received two injections of placebo. As of Week 17, patients randomized to the adalimumab group will receive 40 mg adalimumab every other week until Week 51.
Placebo Group	Placebo comparator	Biological: Adalimumab, Other: PlaceboA total of 53 patients with moderate to severe psoriasis will be randomized in the placebo group. At Day 0 these patients will receive the placebo. It will be administered sub-cutaneously as described in the Canadian product monograph of adalimumab. At Week 16, all these patients will received two injections of adalimumab. As of Week 17, patients randomized to the placebo group will receive 40 mg adalimumab every other week until Week 67.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Patient has plaque psoriasis. Patient has at least a 6 month history of plaque psoriasis.Patient has a Body Surface Area (BSA) covered with psoriasis of 5% or more at Day 0.
Patient is a candidate for systemic therapy. Patient is male or female, 18 to 80 years of age at time of consent. Patient's weight at screening is a maximum of 180 kg. Patient using medication to control angina, hypertension, serum lipids and any medication that can have an effect on inflammation must be on a stable dose for at least 8 weeks before Day 0.
Patient has an ascending aorta atherosclerotic plaque inflammation target-to-background ratio of 1.6 or more as determined by 18-FDG uptake measured by PET scanning.
Patient or patient's partner has been in a menopausal state for at least a year, is surgically sterile (hysterectomy, bilateral oophorectomy, tubal ligation or vasectomy), is clinically diagnosed infertile, has a same-sex partner, is abstinent, or is willing to use effective contraceptive method for at least 30 days before Day 0 and at least 6 months after the last study drug administration. Effective contraceptive methods are:
Barrier methods such as condom, sponge or diaphragm combined with spermicide in foam, gel or cream;

Key exclusion criteria (22 listed)

Patient has spontaneously improving or rapidly deteriorating plaque psoriasis. Patient has other active infections (bacterial, fungal or viral) or skin diseases or skin infections (bacterial, fungal, or viral) 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 (a component of the pre-filled syringe).
Patient has used a non-biological systemic therapy for the treatment of psoriasis less than 30 days before Day 0.
Patient has used an investigational chemical or biological agent less than 30 days or 5 half-lives prior to the Day 0 visit (whichever is longer).
Patient has used a biological therapy for the treatment of psoriasis less than 90 days before day 0.

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
AdalimumabAlso: HumiraInjection of adalimumab (80 mg followed by 40 mg at week 1 and 40 mg EOW thereafter for 52 weeks). For Adalimibab group and Placebo group.	Biological	Group Adalimumab, Placebo Group
PlaceboInjection of placebo that is physicaly identical to adalimumab without the active ingredient at identical intervals.	Other	Placebo Group

Primary outcome

Change from baseline in the target (atherosclerotic plaque) to background (blood) ratio (TBR) from the ascending aorta at Week 16 for patients randomized to adalimumab as compared to patients randomized to placebo
Time frame: Baseline, Week 16 and Week 52 or 68

11 secondary outcomes

Change from baseline in the TBR from the mean of both carotid arteries at Week 16 for patients randomized to adalimumab as compared to patients randomized to placebo
Time frame: Baseline, Week 16 and Week 52 or 68
Change from baseline in the TBR from the ascending aorta 52 weeks after the first dose of adalimumab
Time frame: Baseline and Week 52 or 68
Change from baseline in the TBR from the mean of both carotid arteries 52 weeks after the first dose of adalimumab
Time frame: Baseline and Week 52 or 68
Change from baseline in carotid wall area at Week 16 as measured by MRI for patients randomized to adalimumab as compared to patients randomized to placebo
Time frame: Baseline and Week 16
Change from baseline in carotid wall area as measured by Magnetic Resonance Imaging (MRI) 52 weeks after the first dose of adalimumab
Time frame: Baseline and Week 52 or 68
Change from baseline in hsCRP at Week 16 for patients randomized to adalimumab as compared to patients randomized to placebo
Time frame: Baseline and Week 16
Change from baseline in serum lipids (total cholesterol, LDL- calc, HDL cholesterol, triglycerides) at Week 16 for patients randomized to adalimumab as compared to patients randomized to placebo
Time frame: Baseline, Week 16
Correlation between change from baseline in TBR from the ascending aorta at Week 16 and change from baseline in PASI at Week 16
Time frame: Baseline and Week 16
Correlation between change from baseline in PASI at Week 16 and change in hsCRP at Week 16
Time frame: Baseline and week 16
Correlation between change from baseline in TBR from the ascending aorta at Week 16 and change from baseline in hsCRP at Week 16
Time frame: Baseline and Week 16
Correlation between change from baseline in TBR at Week 16 from the ascending aorta and change from baseline in skin inflammation as measured by PET-Scan at Week 16
Time frame: Baseline and Week 16

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 9 Sep 2016.
Background: PubMed 17032986Gelfand 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.
Background: PubMed 19458634Gelfand JM, Dommasch ED, Shin DB, Azfar RS, Kurd SK, Wang X, Troxel AB. The risk of stroke in patients with psoriasis. J Invest Dermatol. 2009 Oct;129(10):2411-8. doi: 10.1038/jid.2009.112. Epub 2009 May 21.
Background: PubMed 19528427Prodanovich S, Kirsner RS, Kravetz JD, Ma F, Martinez L, Federman DG. Association of psoriasis with coronary artery, cerebrovascular, and peripheral vascular diseases and mortality. Arch Dermatol. 2009 Jun;145(6):700-3. doi: 10.1001/archdermatol.2009.94.
Background: PubMed 17459900Miyasaka Y, Barnes ME, Petersen RC, Cha SS, Bailey KR, Gersh BJ, Casaclang-Verzosa G, Abhayaratna WP, Seward JB, Iwasaka T, Tsang TS. Risk of dementia in stroke-free patients diagnosed with atrial fibrillation: data from a community-based cohort. Eur Heart J. 2007 Aug;28(16):1962-7. doi: 10.1093/eurheartj/ehm012. Epub 2007 Apr 25.
Background: PubMed 17702769van 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.
Background: PubMed 21576552Mehta NN, Yu Y, Saboury B, Foroughi N, Krishnamoorthy P, Raper A, Baer A, Antigua J, Van Voorhees AS, Torigian DA, Alavi A, Gelfand JM. Systemic and vascular inflammation in patients with moderate to severe psoriasis as measured by [18F]-fluorodeoxyglucose positron emission tomography-computed tomography (FDG-PET/CT): a pilot study. Arch Dermatol. 2011 Sep;147(9):1031-9. doi: 10.1001/archdermatol.2011.119. Epub 2011 May 16.
Background: PubMed 15843671Hansson GK. Inflammation, atherosclerosis, and coronary artery disease. N Engl J Med. 2005 Apr 21;352(16):1685-95. doi: 10.1056/NEJMra043430. No abstract available.
Background: PubMed 17993809Moubayed SP, Heinonen TM, Tardif JC. Anti-inflammatory drugs and atherosclerosis. Curr Opin Lipidol. 2007 Dec;18(6):638-44. doi: 10.1097/MOL.0b013e3282f0ee11.
Background: PubMed 17251223Dixon 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.
Background: PubMed 15996054Jacobsson 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.
Background: PubMed 17763428Dixon 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.
Background: PubMed 16877533Turesson C, McClelland RL, Christianson TJ, Matteson EL. Severe extra-articular disease manifestations are associated with an increased risk of first ever cardiovascular events in patients with rheumatoid arthritis. Ann Rheum Dis. 2007 Jan;66(1):70-5. doi: 10.1136/ard.2006.052506. Epub 2006 Jul 28.
Individual participant dataSharing planned: No

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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.

Robert Bissonnette, MD principal investigator

Innovaderm Research

Jean-Claude Tardif, MD principal investigator

Montreal Heart Institute

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Adalimumab in people with Psoriasis and Vascular Inflammation, run by Innovaderm Research Inc. at 5 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 11 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 9 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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. Some participants in this study may receive a placebo. 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?

Change from baseline in the target (atherosclerotic plaque) to background (blood) ratio (TBR) from the ascending aorta at Week 16 for patients randomized to adalimumab as compared to patients randomized to placebo (time frame: Baseline, Week 16 and Week 52 or 68). 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 NCT01722214, which also lists 19 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 9 Sep 2016.