In this study we want to investigate whether early ultrasound findings (e.g. baseline, 2 and 4 weeks) in both joints, tendons, nails and skin can predict response to therapy with apremilast and secukinumab. Also, we want to investigate whether…
ID
Source
Brief title
Condition
- Joint disorders
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main outcomes of the study are the early ultrasound findings (baseline.
week 2 and week 4) and the clinical therapeutic response to apremilast and
secukinumab at 24 weeks
Secondary outcome
Secondary outcomes of the study are ultrasound findings and clinical
assessments at all time points.
Background summary
Psoriatic arthritis is an inflammatory joint disease. Patients with psoriatic
arthritis can be treated with various medications acting upon the inflammatory
responses and the immune system, such medications may have various mechanisms
of action. Examples are methotrexate and anti-TNF medication. Recently two new
therapies for psoriatic arthritis with a new mechanism of action have been
approved: apremilast and secukinumab. For both apremilast and secukinumab
clinical trials have shown good results on both the skin and the joints.
Ultrasound is a technique used to image joints and tendons. Ultrasound can also
be used to image skin and nails, however up until now this has not been done
very often.
Study objective
In this study we want to investigate whether early ultrasound findings (e.g.
baseline, 2 and 4 weeks) in both joints, tendons, nails and skin can predict
response to therapy with apremilast and secukinumab. Also, we want to
investigate whether ultrasound findings in joints, tendons, nails and skin can
provide additional information in monitoring treatment with apremilast and
secukinumab in patients with psoriatic arthritis, next to clinical assessments.
Study design
Multi-center longitudinal prospective observational cohort study
Study burden and risks
Participation in scientific research takes extra time for the patients. During
the study visits, blood will be drawn, which can be associated with pain at the
needle insertion or a small hematoma after the blood collection. On the other
hand, patients might appreciate it to be looked after more often during the
start up of new medication than during normal care. Additionally, the results
of the study will hopefully result in better care for psoriatic arthritis
patients. The ultrasound investigation is non-invasive and safe.
Dr. Jan van Breemenstraat 2
Amsterdam 1056 AB
NL
Dr. Jan van Breemenstraat 2
Amsterdam 1056 AB
NL
Listed location countries
Age
Inclusion criteria
- 18 years or older
- Active psoriatic arthritis, defined as *2 swollen and *2 tender joints
- Starting with apremilast, secukinumab or anti-TNF therapy
Exclusion criteria
- Other active concomitant musculoskeletal disease
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 | NL64072.048.17 |