The aim is to investigate the feasibility of DBS from finger prick for measuring adalimumab drug levels and antibodies-to-adalimumab compared with the results of venepuncture serum sample measurements. As a secondary objective, measurements of…
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
adalimumab drug levels and antibodies-to-adalimumab 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 adalimumab serum concentrations are associated with increased rates of
clinical response, and endoscopic healing. 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-adalimumab. 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 sample
(DBS) 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 adalimumab drug levels and antibodies-to-adalimumab 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 75 patients with Inflammatory Bowel Disease (IBD)
receiving adalimumab induction or maintenance treatment. Blood via venepuncture
and DBS via finger prick will be obtained simultaneously from each patient by a
trained employee. DBS will be obtained by the patient himself at the visit to
the outpatient clinic and at home to test the feasibility of DBS at home.
Study burden and risks
During a regular hospital visit a venepuncture and a finger prick for DBS will
be performed at the same visit by a trained employee. Additional DBS will be
obtained by the patient at the outpatient clinic visit and 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 of female
Diagnosis of IBD
Receiving adalimumab therapy
Exclusion criteria
Contra-indication to adalimumab (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 | NL64574.018.18 |