A prospective study to assess the effect of adalimumab on cardiovascular biomarkers in participants with severe chronic plaque psoriasis

An open-label, prospective pilot study evaluating the effect of adalimumab on endothelial function and on cardiovascular biomarkers in severe chronic plaque psoriasis patients eligible for biologic treatment in Australia

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000419763

Enrollment

Registered

2013-04-15

Start date

2013-04-30

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This is a prospective, single-centre study of adalimumab in participants with severe chronic plaque psoriasis and eligible for biologic treatment as per Australian Pharmaceutical benefits Scheme (PBS) criteria. We hope this study confirms our hypothesis that patients treated with adalimumab for a 12 weeks period will have improved endothelial function compared to pre-treatment score.

Interventions

Patient who are deemed eligible for adalimumab according to PBS Australia biologics criteria will be administered with 80mg adalimumab subcutaneously at week 0, 40mg at week 1 and 40 mg subcutaneously every other week. Patients are reviewed at week 6, 12 and every 3 months thereafter if they are on treatment with adalimumab. A PASI (Psoriasis assessment severity index) is performed at each visit to monitor response. Patients will remain in treatment indefinitely if they respond to adalimumab.

Study design

Allocation

Non-randomised trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

Patient who has had severe chronic plaque psoriasis for at least 6 months with no previous exposure to biologics, and is eligible for biologics as per Australian PBS requirements and has been selected to start adalimumab by a dermatologist

Exclusion criteria

Patients not starting on adalimumab as their first biological agent or has had prior biologic treatment

Outcome results