To determinate the efficacy and safety of golimumab in patients with psoriatic arthritis in daily clinical practice prospectively. In addition, the effect of treatment with golimumab on the lipid profile will be monitored during this study and…
ID
Source
Brief title
Condition
- Autoimmune disorders
- Joint disorders
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- ACR20 response: 20% improvement or 10 point decrease on 100mm VASscales
- PASI improvement
- MDA status
Secondary outcome
-The number of adverse events (infections, malignancies, mortality)
- LEI Improvement
-Number of digits with dactylitis
-Number of nails with nail psoriasis
-ESR and/or CRP
-The lipid profile
-inflammation processes
-Relation between genetic polymorphisms and the efficacy of golimumab
-Radiographic progression
-Changes in bone mineral density.
Background summary
1) Golimumab, a TNF inhibitor, has recently been approved in the Netherlands
for the traetment of psoriatic arthritis. As efficacy in daily clinical
practice can differe from the clinical (registration) trials, e.g. due to
different patient groups, it is important to monitor the daily clinical
practice.
2) Recently provisional evidence has been published for possible benificial
effects of TNF inhibitors on the prevention of cardiovascular disease, what may
be mediated through modulation of the lipid profile
Study objective
To determinate the efficacy and safety of golimumab in patients with psoriatic
arthritis in daily clinical practice prospectively. In addition, the effect of
treatment with golimumab on the lipid profile will be monitored during this
study and inflammation processes in the blood will be monitored.
Study design
Prospective observational cohort study in patients whom golimumab is started.
Efficacy and safety data will be collected throughout the study. Lipid profiles
will be compared to baseline as well as the inflammation process in the blood.
Study burden and risks
The additional 'burden'consists of an extra blood sample taken at moments that
this would already have been done in view of routine patient care
dr jan van breemenstraat 2
1056AB
NL
dr jan van breemenstraat 2
1056AB
NL
Listed location countries
Age
Inclusion criteria
patients with psoriatic arthritis in whom golimumab treatment is started
written informed consent
Exclusion criteria
contraindications against golimumab treatment
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 | NL39474.048.12 |