Effect of Adalimumab on Vascular Inflammation in Patients With Moderate to Severe Plaque Psoriasis
|ClinicalTrials.gov Identifier: NCT00940862|
Recruitment Status : Completed
First Posted : July 16, 2009
Last Update Posted : October 28, 2011
|Condition or disease||Intervention/treatment||Phase|
|Psoriasis Vascular Inflammation Coronary Atherosclerosis||Biological: adalimumab Device: UVB Phototherapy Other: Topical treatment||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Pilot Study on the Effect of Adalimumab on Vascular Inflammation in Patients With Moderate to Severe Plaque Psoriasis|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||August 2011|
A 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)
Injection of adalimumab (80 mg followed by 40 mg at week 1 and 40 mg EOW thereafter for 15 weeks)
Other Name: Humira
Active Comparator: Non-systemic treatment.
A total of 10 patients will be randomized to non systemic therapy for psoriasis (topical treatments and/or UVB phototherapy).
Device: UVB Phototherapy
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.
Other Name: Ultra violet light BOther: Topical treatment
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.
- 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 ]
- 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. [ Time Frame: Day -10 to -1, Day 105. ]
- 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. [ Time Frame: Day 0, 28, 56, 112 ]
- 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 [ Time Frame: Day 0, 28, 56, 112, 175 ]
- 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. [ Time Frame: Day 0, 28, 56, 112 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00940862
|Montreal Heart Institute|
|Montreal, Quebec, Canada, H1T 1C8|
|Innovaderm Research Inc|
|Montreal, Quebec, Canada, H2K 4L5|
|Principal Investigator:||Robert Bissonnette, MD||Innovaderm Research|
|Principal Investigator:||Jean-Claude Tardif, MD, FRCPC||Montreal Heart Institute|