The primary goal of this study is to determine whether it is possible to discontinue treatment with TNF blocking therapy in patients suffering from RA when the patient has had stable low disease activity, without the occurence of an exacerbation.
ID
Source
Brief title
Condition
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome: the primary outcome measure is the percentage of patients who
experience an exacerbation of RA during the first year: increase of DAS28 >3.2
with a delta DAS28 of > 1.2.
Secondary outcome
Number of patients stopped anti-TNF at 12 months
Timespan of anti tNF usage, volume and medical costs
DAS28 value
Percentage of patients with a DAS28<3.2
Percentage of patients with a DAS28<2.6
Percentage of patients in remission according to ACR/EULAR criteria
Occurrence of side effects
Patient Satisfaction
Function (HAQ questionnaire)
Background summary
For the treatment of rheumatoid arthritis (RA) TNF blocking medication is very
effective. TNF blocking medication, however, are relatively very expensive
(1000 euro per month). Considering the chronic nature of RA patients are almost
always treated by TNF blocking therapy for a long period of time. This
longterm ( *lifelong*) treatment entails two problems: longterm safety and
high costs for the Dutch healthcare budget.
Study objective
The primary goal of this study is to determine whether it is possible to
discontinue treatment with TNF blocking therapy in patients suffering from RA
when the patient has had stable low disease activity, without the occurence of
an exacerbation.
Study design
The study design is an open label randomised controlled study design where
patients are randomised to * discontinue TNF blocking therapy* or continue all
anti-rheumatic medication including the TNF blocking therapy.
Study burden and risks
Except for the randomisation,no interference with the current care of patients
with RA take place. Patients with RA will be seen by a rheumatologist and a
nurse once every 3 months, as the CBO guideline advises. All measurements which
are part of standard care will be performed every 3 months. Patients will be
followed for a maximum of 2 years (end of study period). During each visit to
the outpatient clinic blood will be drawn for the determination of inflammation
parameters, which is also a part of standard care of RA-patients in the
Netherlands.
Patient risks:
The discontinuation of TNF blocking therapy entails the risk that disease
activity may rise. However, the study desing guarantees that at an exacerbation
of disease activity (DAS28>3.2 PLUS Delta Das28>1,2, or DAS28>3.2 PLUS Delta
DAS28>0,6 but <1.2 at 2 separate measurements with 2 to 3 month intervals) the
same TNF-blocker can be restarted. If this happens in the control group the
patient may switch to another treatment with a biological, as is also customary
in usual care. The patients will be monitored frequently, by measuring the
disease activity by means of the DAS28 so that in case of an exacerbation
treatment can be adjusted swiflty. The risk of unnecessarily continuing TNF
blocking therapy is an increased risk of malignities and infections.
Geert Grooteplein Zuid 8
6525 GA Nijmegen
NL
Geert Grooteplein Zuid 8
6525 GA Nijmegen
NL
Listed location countries
Age
Inclusion criteria
•Diagnosis Rheumatoid Arthritis according to the 1987 ACR criteria
•Treated for at least 1 year with a TNF-blocker and stable (no dose changes) DMARD treatment for the preceding 6 months
•Low disease activity for at least 6 months, according to both patient and rheumatologist, and a DAS28<3.2 measured at at least two different time points
•Signed informed consent.
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 | NL36793.091.11 |