To determinate the efficacy and safety of golimumab in patients with ankylosing spondylitis in daily clinical practice prospectively. In addition, the effect of treatment with golimumab on the lipid profile will be monitored during this study.
ID
Source
Brief title
Condition
- Autoimmune disorders
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- ASAS20% response: When there is 20% improvement (and at least 10 points
decrease on the 100mm VAS-scales) of at least three out of four domains of the
following parameters: inflammation/morning stiffness (BASDAI), function
(BASFI), pain (VAS) and patient global assessment (VAS), this therapy will be
considered as effective.
- ASDAS improvement
- BASDAI 50 response
Secondary outcome
- the number of adverse events (infections, malignancies, mortality)
- improvement of mobility (BASMI)
- the peripheral joint swelling (44 joint count)
- the ESR and/or CRP
- the lipid profile
- the production of ANA
- relation between genetic polymorphisms and the efficacy of golimumab
- radiographic progression (conventional radiography, mSASSscore)
- occurrence of extraspinal manifestations (uveitis, colitis, cardiovascular
events)
- changes in bone mineral density.
Background summary
1) Golimumab, a TNF inhibitor, has recently been approved in the Netherlands
for the treatment of ankylosing spondylitis. 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
ankylosing spondylitis in daily clinical practice prospectively. In addition,
the effect of treatment with golimumab on the lipid profile will be monitored
during this study.
Study design
Prosepctive 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
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
Amsterdam 1056AB
NL
dr jan van breemenstraat 2
Amsterdam 1056AB
NL
Listed location countries
Age
Inclusion criteria
patients with ankylosing spondylitis 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 | NL39155.048.11 |