Status:
COMPLETED
Immune Metabolic Associations in Psoriatic Arthritis
Lead Sponsor:
NHS Greater Glasgow and Clyde
Conditions:
Psoriasis
Psoriatic Arthritis
Eligibility:
All Genders
18+ years
Brief Summary
To use apremilast in clinical practice as a molecular probe to evaluate the effects of PDE4 inhibition on the cardiometabolic status and immune profile in patients with PsA and psoriasis.
Detailed Description
Psoriatic arthritis (PsA) and psoriasis are characterised by immune, metabolic, and vascular dysfunction. There is an increase in Major Adverse Cardiovascular Events in people with PsA and psoriasis n...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Have either a diagnosis of PsA (n=40) fulfilling the CASPAR criteria or Chronic plaque psoriasis (confirmed by dermatologist) (n=20)
- Eligible for apremilast therapy in line with the licence and SMC approval
- Able and willing to give written informed consent and comply with the requirements of the study protocol.
Exclusion
- History of or current autoimmune rheumatic disease other than PsA or psoriasis
- Severe renal disease (eGFR ≤30ml/min)
- Liver disease with ALT/AST \>4 times ULN
- Haemoglobin ≤9 g/dl
- Inflammatory bowel disease or coeliac disease
- Patients with any cancer currently receiving chemo- or radiotherapy
- Severe depression and/or history of suicidal ideation or attempts.
- Currently receiving other leflunomide or biologics
- Current oral steroids or IM steroids within 6 weeks of baseline.
- Clinically meanigful weight loss of \>3kg, current or planned use of weight loss medication e.g. orlistat, or severe calorie restriction within the first 3 months of the study
- Current insulin therapy for diabetes
- Current use of GLP-1 agonists or dipeptidyl peptidase-4 (DPP-IV) inhibitors
- Statin therapy started/stopped or dose altered within 3 months of baseline visit
- Thyroxine started or dose altered within 6 weeks of baseline
- Acitretin within 8 weeks of baseline
- Pregnancy or breast feeding
- Women planning to become pregnant during the study period
- Women of reproductive age or male partners of women of reproductive age unwilling to use effective contraception while taking apremilast \& for at least 28 days after last dose of apremilast
- Known HIV, hepatitis B and C infection
- Patient unable to participate in long term data collection
Key Trial Info
Start Date :
June 12 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 25 2019
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03399708
Start Date
June 12 2017
End Date
October 25 2019
Last Update
November 25 2019
Active Locations (1)
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1
Glasgow Royal Infirmary
Glasgow, Scotland, United Kingdom, G31 2ER