Immune Metabolic Associations in Psoriatic Arthritis

NCT03399708 | Completed DMC

• 1 other identifier: GN16RH008
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis; Psoriatic Arthritis

Keywords

apremilast; PDE4 inhibition; cardiometabolic; immune profile

Outcome Measures

Primary Outcomes (1)

• Changes in cardiometabolic profile

  To characterise dynamic changes in cardiometabolic profile with formal assessment at 3 months.

  3 months

Secondary Outcomes (8)

• Lipids

  6 months

• NMR metabolomic profile

  6 months

• Blood pressure

  6 months

• endothelial function

  3 months

• MRI imaging

  3 months

Interventions

Apremilast 30mg DRUG

Apremilast will used in line with its license. This includes the standard dose titration scheme (see section 6) and then the usual maintenance dose of 30 mg twice daily orally.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with PsA and psoriasis.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead

Study Sites (1)

Glasgow Royal Infirmary

Glasgow, Scotland, G31 2ER, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Routine blood (FBC, creatinine and/or GFR, LFTs) Acute phase reactants: ESR, CRP Oral Glucose Tolerance test (OGTT) = 0,30,60,90,120min (glucose, insulin) =0, 30, 120 min (GLP-1) Fasting lipids, HbA1c, glucose, insulin, GLP-1 levels Blood samples for NMR metabolomic profiling Circulating cytokines \& adipokines

MeSH Terms

Conditions

Psoriasis; Arthritis, Psoriatic

Interventions

apremilast

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases

Study Officials

• Stefan Siebert, MBChB PhD

  Glasgow University and NHS GGC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: January 16, 2018
• Study Start: June 12, 2017
• Primary Completion: October 12, 2019
• Study Completion: October 25, 2019
• Last Updated: November 25, 2019

Record last verified: 2019-11

Locations

GB (1)