At CHDR, experience has been gained with the assessment of the in vitro inhibition by MAP kinases of the LPS-induced TNFα release in healthy male volunteers. However, relatively little is known on the inhibition by MAP-kinases in other populations.…
ID
Source
Brief title
Condition
- Coronary artery disorders
- Autoimmune disorders
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
activation markers of inflammation (cytokines, chemokines, etc)
Secondary outcome
n/a
Background summary
Anti-inflammatory therapy is pursued as an approach to treatment for
inflammatory diseases such as rheumatoid arthritis, Crohn*s disease and
psoriasis. Rational development of such compounds would be facilitated when the
possible variability in response in different target populations is known. The
response to MAP-kinase inhibition can be assessed using the LPS whole blood
stimulation test. Additional inducers can be used in this study.
Study objective
At CHDR, experience has been gained with the assessment of the in vitro
inhibition by MAP kinases of the LPS-induced TNFα release in healthy male
volunteers. However, relatively little is known on the inhibition by
MAP-kinases in other populations. This is not trivial as there are indications
that gender and disease state may have a substantial influence on the
inhibition. In the whole blood stimulation test also other anti-inflammatory
compound can be used.
In addition, technical advances enable to evaluate the response of more
cytokines simultaneously using the Biochip Array Technology and the so-called
Multiplex technology.
The objective of this study is to explore the characteristics of the whole
blood LPS-stimulation test or other inducers and its in vitro inhibition in
healthy volunteers, and patients with Crohn*s disease, asthma, psoriasis
rheumatoid arthritis, or proven atherosclerotic disease
Study design
Open, observational study with 90 participants. From each patient a single
blood draw will be taken.
Study burden and risks
n/a
Zernikedreef 10
Leiden 2333CL
NL
Zernikedreef 10
Leiden 2333CL
NL
Listed location countries
Age
Inclusion criteria
healthy males
healthy female volunteers: pre- and post-menopausal
patients with rheumatoid arthritis: active disease and with or without treatment with MTX
patients with Crohn's disease: clinically confirmed diagnosis of disease
patients with psoriasis: clinically confirmed diagnosis of disease, PASI score>5
patients with asthma: clinically confirmed diagnosis of disease
patients with proven atherosclerotic disease
Exclusion criteria
general: any clinically significant disorder (current or past medical history or physical examination) that in the opinion of the investigator precludes study participation
patients: clinically significant abnormalities and recent treatment with anti-TNF therapy
Design
Recruitment
metc-ldd@lumc.nl
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 | NL21958.058.08 |