The aim of the present study is to identify the association of inflammation in PsA with measures of abdominal fat and cardiometabolic risk factors and evaluate the body composition changes in PsA patients receiving apremilast. Secondly, to assess…
ID
Source
Brief title
Condition
- Joint disorders
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Body composition assessed using whole body DEXA
Secondary outcome
Medical history, date of birth, gender, ethnicity, smoking status, use of
alcohol, physical activity, date of diagnosis, comorbidity, concomitant
medication, use of concomitant and prior DMARDs, height, weight, blood
pressure, heart rate, abdominal wall and hip circumference, presence of
peripheral arthritis, patient pain VAS, patient global assessment of disease
activity (VAS), PASI, LEI, RAPID, ESR, hsCRP, HbA1c (only in patients diagnosed
with diabetes mellitus), TC, HDL, LDL, Apo, HDL efflux capacity, glucose, ICAM,
VCAM, adiponectines, PCSK9, cIMT, DECT-scan
Background summary
Psoriatic arthritis (PsA) is an inflammatory joint disease associated with an
increased risk of cardiovascular (CV) events. Apremilast, an oral
phosphodiesterase 4 inhibitor (PDE4), has recently been approved for treatment
of PsA. PDE4 is one of the major phosphodiesterases expressed in leukocytes.
PDE4 inhibition by apremilast elevates cyclic adenosine monophosphate (cAMP)
levels in immune cells, which in turn down-regulates the inflammatory response
by reducing the expression of pro-inflammatory mediators and increasing the
production of anti-inflammatory mediators. In view of these anti-inflammatory
effects of apremilast we expect favorable effects on the cardiovascular burden
in PsA patients. Body composition, specifically adipose tissue, is likely to
play an important role in cardiovascular disease. By investigation the
mechanism of apremilast at several levels, e.g. basal metabolic, cholesterol
efflux, body composition and plaque size and composition, we can test our
hypothesis of apremilast influencing cholesterol efflux, and simultaneously
measure the effects of that body composition and on atherosclerosis in the
aorta and coronary arteries. This provides us with novel insights in the
relation of inflammation and atherosclerosis, and mechanisms in with therapies
influence this.
Study objective
The aim of the present study is to identify the association of inflammation in
PsA with measures of abdominal fat and cardiometabolic risk factors and
evaluate the body composition changes in PsA patients receiving apremilast.
Secondly, to assess plaque composition measured by DECT scanning. Thirdly, to
evaluate changes in cIMT and cardio-metabolic markers during anti-inflammatory
therapy with apremilast.
Study design
Single center, longitudinal prospective translational study
Study burden and risks
Participation in scientific research takes patients extra time because of the
additional tests being conducted. During study visits, blood will be drawn,
which is associated with pain at the needle insertion or a small hematoma after
the blood collection.
If patients undergo the DXA scan and the DECT, they are exposed to radiation.
The extra radiation received with this study is approximately 10 mSv. The extra
radiation is within the standards that apply in our country for this type of
additional radiation exposure.
Dr. Jan van Breemenstraat 2
Amsterdam 1056 AB
NL
Dr. Jan van Breemenstraat 2
Amsterdam 1056 AB
NL
Listed location countries
Age
Inclusion criteria
- Adult (>=18 years) patients with active psoriatic arthritis
- Starting apremilast
Exclusion criteria
- Inability or unwillingness to sign informed consent
- Contraindication for apremilast (i.e. pregnancy and hypersensitivity to apremilast and/or its excipients)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL59047.048.16 |