To determine the efficacy and safety of tocilizumab in the daily clinical practice situation for at least 36 months in comparison to the reported efficacy and safety in clinical trials.There will be a particular focus of the effect of tocilizumab on…
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 comparing disease
activity, radiological progression and functional capacity during follow-up.
Safety will be determined by the occurrence of (serious) side effects.
Secondary outcome
There will be a particular focus of the effect of tocilizumab on lipid profile,
bone density changes as well as risk factors for cardiovascular disease and
osteoporosis.
prognostic determinators will be assessed.
Background summary
Tocilizumab, an IL-6 inhibitor, has recently been approved in the Netherlands
for the treatment of moderate to severe rheumatoid arthritis (RA). As clinical
efficacy (and safety) 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. In addition, prognostic determinators can
be assessed.
Study objective
To determine the efficacy and safety of tocilizumab in the daily clinical
practice situation for at least 36 months in comparison to the reported
efficacy and safety in clinical trials.
There will be a particular focus of the effect of tocilizumab on lipid profile,
markers of bone metabolism as well as risk factors for cardiovascular disease
and osteoporosis.
Study design
Prospective observational follow-up study
Study burden and risks
Patients will be treated intravenously at the day care unit of the outpatient
clinic at the Jan van Breemen Institute. The additional *burden* consists of an
extra amount of blood (approximately 20 cc) at moments that this would already
have been done in view of routine patient care. The patients will also be asked
to give urine at the same moments as mentioned above. This will be done 7 times
in the first year en every half year after the first year.
Dokter Jan van Breemenstraat 2
1056 AB Amsterdam
NL
Dokter Jan van Breemenstraat 2
1056 AB Amsterdam
NL
Listed location countries
Age
Inclusion criteria
rheumatoid arthritis and treatment with tocilizumab
Exclusion criteria
contraindications for treatment with tocilizumab
No signed informed consent
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 | NL32159.048.10 |