The primary objective of this pilot study is to compare the venous infliximab blood level and anti-drug-antibodies with the bloodspot-technology in children with inflammatory bowel disease. The hypothesis is that there will be a good correlation…
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study objective is comparison between the venous infliximab blood
level/anti-drug-antibodies and the bloodspot-technology.
Secondary outcome
Not apply
Background summary
Inflammatory bowel disease include Crohn*s disease, Ulcerative Colitis and
IBD-unclassified which presents during childhood and adolescence in 25% of its
patients. The incidence has risen the recent decades. Increased concentrations
of tumor necrosis factor-* (TNF*) are found in the mucosa of IBD patients. This
key role of TNF* has led to the development of biologic therapy based on the
administration of monoclonal antibodies which bind and inactivate TNF*, for
example infliximab. Efficacy of the treatment is correlated with the blood
level and the development of anti-drug-antibodies. The infliximab blood levels
are measured through venous collection of blood. Recently Sanquin developed a
bloodspot-technology to measure the infliximab blood level and
anti-drug-antibodies with a bloodspot collected in a small tube. This capillary
blood sample is less intense for children and can be measured easier and more
often.
Study objective
The primary objective of this pilot study is to compare the venous infliximab
blood level and anti-drug-antibodies with the bloodspot-technology in children
with inflammatory bowel disease.
The hypothesis is that there will be a good correlation between this blood
levels, so that the bloodspot-technology can be used in the pediatric
population with inflammatory bowel disease.
Study design
We will perform a prospective clinical pilot study.
Study burden and risks
When our hypothesis is correct this will be beneficial for children with
inflammatory bowel disease in the future. The treatment can be better adapted
to the individual patient. In case of complaints the blood levels will be
easier to determine on which the infliximab dosage can be adapted. The
capillary blood collecting is the additional achievement that the patients
undergo. Potential hazards of a capillary blood collection, for example
hematoma or sensitivity of the finger, are minimal. The risk associated with
the blood withdrawal can be considered negligible and the extra burden will be
minimal.
Wytemaweg 80 Wytemaweg 80
Rotterdam 3015 CN
NL
Wytemaweg 80 Wytemaweg 80
Rotterdam 3015 CN
NL
Listed location countries
Age
Inclusion criteria
- Patients with Crohn's disease, Ulcerative Colitis and IBD-unclassified
- Age from six to sixteen years old
- Treatment with infliximab
- Indication to determine infliximablevel and anti-drug-antibodies
- Obtain informed consent
Exclusion criteria
- Age under six and above seventeen years old
- No informed consent
- Children and parents/guardians who do not speak the Dutch language
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 | NL60785.078.17 |