To determinate the efficacy and safety of subcutaneous (s.c.) tocilizumab in patients with rheumatoid arthritis in a daily clinical setting. In addition, to monitor the effect of treatment with tocilizumab s.c. on the lipid profile, markers of bone…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- DAS28 score and response is defined as the EULAR criteria of a good or
moderate response and a score of <3.2
- Effect on RAPID-3/MDHAQ-2
Secondary outcome
- The number of adverse events (infections, malignancies, mortality)
- ESR and/or CRP
- The lipid profile
- Inflammation processes
- Relation between genetic polymorphisms and the efficacy of tocilizumab
- Radiographic progression
- Changes in bone mineral density
- Cardiovascular risk factors
Background summary
Recently, tocilizumab s.c. is available in the Netherlands for the treatment of
rheumatoid arthritis. It is important to determine efficacy and safety in daily
clinical practice, because this can differ from clinical trials. Further,
prognostic markers can be determined.
Study objective
To determinate the efficacy and safety of subcutaneous (s.c.) tocilizumab in
patients with rheumatoid arthritis in a daily clinical setting. In addition, to
monitor the effect of treatment with tocilizumab s.c. on the lipid profile,
markers of bone metabolism, and risk factors for cardiovascular disease.
Study design
Prospective observational cohort study in rheumatoid arthritis patients
starting with tocilizumab s.c. The first visit will take place before the start
of treatment and the patient will be followed at 1 month, 4 months, 6 months, 1
year, 1.5 year, 2 years, and once yearly thereafter.
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. At each
visit 12.5 ml blood will be collected and stored (encoded) at Reade with the
purpose to answer future research questions concerning treatment with
subcutaneous tocilizumab. During the first visit only, an extra 22 ml of blood
will be collected for research into genetic factors whom are of potential
influence on the process of inflammation and are potential predictors for
response to therapy.
Dr. Jan van Breemenstraat 2
Amsterdam 1056AB
NL
Dr. Jan van Breemenstraat 2
Amsterdam 1056AB
NL
Listed location countries
Age
Inclusion criteria
Patients:
- who are diagnosed with RA;
- in whom tocilizumab s.c. is prescribed by their treating rheumatologist; and
- who gave written informed consent.
Both bio-naive patients as patients who failed on previous biologic agents will be included.
Exclusion criteria
Patients with contraindications for tocilizumab treatment. For patients previously treated with intravenous tocilizumab a washout period of 4 weeks is required.
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 | NL50732.048.14 |