To determinate the efficacy and safety of golimumab in rheumatoid arthritis patients in daily clinical practice during 48 months. 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
Efficacy will be determined in comparison to baseline by measuring disease
activity, radiological progression and functional capacity during follow-up.
Safety will be determined by the occurrence of side effects. Changes in lipid
profile markers during the four years of treatment will be analyzed versus
baseline.
Secondary outcome
nvt
Background summary
1) Golimumab, a TNF inhibitor, has recently been approved in the Netherlands
for the treatment of moderate to severe rheumatoid arthritis. As efficacy in
daily clinical practice can differ 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 beneficial
effects of TNF inhibitors on the prevention of cardiovascular disease, which
might be mediated through modulation of the lipid profile.
Study objective
To determinate the efficacy and safety of golimumab in rheumatoid arthritis
patients in daily clinical practice during 48 months. In addition, the effect
of treatment with golimumab on the lipid profile will be monitored during this
study.
Study design
Prospective observational cohort study in patients in 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
1056 AB Amsterdam
NL
dr Jan van Breemenstraat 2
1056 AB Amsterdam
NL
Listed location countries
Age
Inclusion criteria
patients with rheumatoid 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 | NL35215.048.11 |