Determine how many patients with IBD, treated with anti-TNF one year after change to thiopurine treatment are still effectively treated for their IBD.
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Which % of the studypopulation is succesfully changed into optimized thiopurine
treatment?
Secondary outcome
1. Which subgroups are present?
2. Which % and which subgroups can be succesfully changed into a optimized
thiopurine treatment. (with TNF treatment)
3. Which % and which subgroup can stop the anti-TNF long term (> one year)?
Background summary
Anti-TNF (Remicade and Humira) can be a very effective treatment for
Inflammatory Bowel Disease (IBD) ( especially Morbus Chrohn). Anti-TNF is
rather expensive and can only be given if the treatment with the much cheaper
thiopurines (imuran and 6-MP) had failed. Treatment with thiopurines is
recently significantly improved. Drug monitoring and correction of the
6-TG-6-MMP ratio with Allopurinol with If necessary dose adjustment increases
the effectiveness of thiopurines. Maybe it is possible to change patients with
anti-TNF treatment into treatment with thiopurine. We have defined thiopurine
treatment failure according to the current views:
1. allergic reaction as a side effect (such as pancreatitis).
2. other side effects (from Imuran as well as 6-MP).
3. treatment failure despite metabolite optimized treatment
Analysis of our cohort turned out that 54% of our IBDpatients with anti-TNF not
fit these criteria. For this group there is a change to stop anti-TNF and
removed it for thiopurine therapie.
Study objective
Determine how many patients with IBD, treated with anti-TNF one year after
change to thiopurine treatment are still effectively treated for their IBD.
Study design
After informed consent patients will start with thiopurine treatment. This will
be optimized with metabolite levels. Activity of the IBD shall be monitored.
After optimized treatment with thiopurine the anti-TNF will be stopped.
Patients will be intensively be monitored during this process.
Intervention
treatment with thiopurines.
Study burden and risks
Risk: side effect medication.
Burden:
6 visits to the hospital every 3 month.
In between every month telephone contact every month.
During visit in hospital: physical examination, IBD activity score, blood test
and tools test.
Van Swietenplein 1
Groningen 9728 NT
NL
Van Swietenplein 1
Groningen 9728 NT
NL
Listed location countries
Age
Inclusion criteria
18 years or older
mentally compentent
diagnose of IBD
signed informed consent
well known history
Exclusion criteria
pregnant women
existing treatment with MTX
history of fistels
second indication for anti TNF, such as Bechterew
serious co-morbidiy
unable to understand or write Dutch
serious transfusionreaction on infliximab or Humira in the past
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 | NL44312.099.13 |
| Other | volgt |