The aim is to investigate the feasibility of DBS from finger prick for measuring infliximab drug levels and ATIs compared with the results of venepuncture serum sample measurements. As a secondary objective, measurements of albumin and CRP will also…
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary: to investigate feasibility of DBS from finger prick for measuring
infliximab drug levels and ATIs compared with the results of venepuncture serum
sample measurements.
Secondary outcome
To compare levels of albumin and CRP from DBS with the results of venepuncture
serum sample measurement and to investigate feasibility of DBS from finger
prick at home.
Background summary
Higher infliximab (IFX) serum concentrations are associated with increased
rates of clinical response, endoscopic healing and lower rates of surgery. The
use of anti-TNF therapy is however complicated by loss of response (LOR). The
exact mechanism behind LOR is unknown, but it is likely that an increased
clearance of anti-TNF plays a role. One of the factors influencing clearance is
the formation of antidrug-antibodies, in this case antibodies-to-infliximab
(ATIs).
In recent years it has become clear that therapeutic drug monitoring (TDM) can
be an important tool to optimize outcome of anti-TNF treatment. The dried blood
spot (DBS) sampling method with blood obtained via a finger prick greatly
facilitates TDM, since patients can administer this finger prick themselves at
any time.
Therapeutic monoclonal antibodies and antidrug-antibodies can be accurately
quantified in DBS and anti-TNF measurements in DBS have been previously
described in patients with inflammatory bowel disease treated with infliximab
or adalimumab (n=20).
Study objective
The aim is to investigate the feasibility of DBS from finger prick for
measuring infliximab drug levels and ATIs compared with the results of
venepuncture serum sample measurements.
As a secondary objective, measurements of albumin and CRP will also be compared
between both methods. Also, feasibility of DBS from finger prick at home will
be investigated.
Study design
A longitudinal study of 40 patients with Inflammatory Bowel Disease (IBD)
receiving infliximab induction or maintenance treatment. Blood via venepuncture
and DBS via finger prick will be obtained simultaneously from each patient at 3
timepoints by a trained employee. One extra DBS will be obtained by the patient
himself at home to test the feasibility of DBS at home.
Study burden and risks
Due to participation in this study, 1 extra visit to the outpatient clinic will
be needed. Blood will be withdrawn during regular visits for infliximab
infusion. During the extra visit a regular venepuncture will be used and a
finger prick will be performed for DBS at the same visit by a trained employee.
One additional DBS will be obtained by the patient himself at home.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
- Age from 18 years, either male or female
- Diagnosis of IBD
- Receiving infliximab therapy
Exclusion criteria
- Contra-indication to infliximab (TBC, severe infections or congestive heart failure)
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 | NL58097.018.16 |