Primary objectives: - To determine in which percentage of the included patients tocilizumab is successfully tapered or discontinued after 12 months (successful = lower dose than at baseline with a DAS28-ESR
ID
Source
Brief title
Condition
- Other condition
- Autoimmune disorders
Synonym
Health condition
gewrichtsaandoeningen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoints of this study are:
- the percentage of patients in whom tocilizumab is successfully tapered after
12 months (successful = lower dose than at baseline with a concurrent DAS28-ESR
<=3.2).
- the serum concentration range of tocilizumab above which low disease activity
is maintained during tapering of tocilizumab.
Secondary outcome
The secondary endpoints of this study are:
- the mean or median dose reduction or interval extension of tocilizumab
between baseline and 12 months (in mg and percentages).
- the mean or median change in disease activity scores between baseline and 12
months.
Background summary
Tocilizumab is a frequently used biological in the treatment of rheumatoid
arthritis. Previous studies have shown that tocilizumab can be successfully
reduced or discontinued in >=50% of the patients with low disease activity and
this may decrease overtreatment and health care costs. However, in some
patients, disease activity may increase during tapering which may have been
caused by a tocilizumab serum concentration that was too low to maintain low
disease activity. For some biologicals used in rheumatoid arthritis,
therapeutic drug monitoring has proven to be effective in optimizing clinical
response. However, exact reference values for tocilizumab remain unknown. In
this study, we hypothesize that tocilizumab can be successfully tapered in a
substantial part of the patients and that the disease activity will increase
when the tocilizumab serum concentration drops below a certain critical level.
Study objective
Primary objectives:
- To determine in which percentage of the included patients tocilizumab is
successfully tapered or discontinued after 12 months (successful = lower dose
than at baseline with a DAS28-ESR <=3.2).
- To identify the serum concentration range above which low disease activity is
maintained during tapering of tocilizumab.
Secondary objectives:
- To determine the mean or median dose reduction or interval extension between
baseline and 12 months (in mg and percentages).
- To determine the mean or median change in disease activity scores between
baseline and 12 months.
Study design
Mono-center, single-arm, prospective pilot study
Intervention
Tocilizumab will be tapered every 3 months according to an existing dose
optimization protocol for tocilizumab. Tocilizumab trough levels will be
measured before every next dose tapering step.
If disease activity increases during tapering, temporarily treatment with
NSAIDs or corticosteroids is allowed. If disease activity remains high,
tocilizumab will be restarted or increased to the last effective dose. In case
disease activity still remains high, the dose will be further increased step by
step until the registered dose is reached.
Study burden and risks
Dose tapering of tocilizumab is already part of daily clinical practice. The
risk of side effects is not affected or possibly even lower due to dose
reduction of tocilizumab. Different from standard care is that an extra blood
sample will be taken before every next dose tapering step. Depending on the
success of dose tapering, up to 4 tocilizumab trough levels will be determined
per patient. Possible risks of blood sampling are that patients may experience
pain or develop a hematoma. In addition, participants may have more control
visits in the outpatient clinic of rheumatology (once every 3 months instead of
once every 6 months).
Kleiweg 500
Rotterdam 3045 PM
NL
Kleiweg 500
Rotterdam 3045 PM
NL
Listed location countries
Age
Inclusion criteria
- >=18 years of age - Diagnosed with rheumatoid arthritis and treated for it in
Franciscus Gasthuis and Vlietland - Treated with intravenous or subcutaneous
tocilizumab - Low disease activity for at least the last 6 months while using
tocilizumab with a current DAS28-ESR <=3.2. - Sufficient understanding of the
Dutch language.
Exclusion criteria
none
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 | NL84135.100.23 |