To get a better understanding of the pharmacokinetics of IFX in Ulcerative Colitis, especially with regards to the circulating drug levels in the first 42 days after the start of therapy, and in relationship to the *inflammatory burden* by…
ID
Source
Brief title
druglevel Infliximab
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Drug level of Infliximab at several time points
Secondary outcome
Development of antibodies, fecal calprotectin en serum CRP, Albumine level,
Simple Clinical Colitis Activity Index, colonoscopy and biopsies at the
different time points
Background summary
Infliximab (IFX) has become a common treatment for Ulcerative Colitis (UC) and
the first choice in patients with steroid-refractory disease. Among patients
who initially respond to infliximab up to 40% will subsequently lose response.
The development of antibodies to infliximab has been associated, in several
studies, with decreased drug concentrations and a decreased clinical response.
However, drug consumption due to massive presence of inflammation and mucosal
TNF may represent another mechanism of early suboptimal response.
One Canadian study showed that patients with detectable trough level of
infliximab not only have a higher rate of clinical remission, but also a lower
serum CRP and a higher rate of endoscopic healing.
We hypothesize that a suboptimal effect of infliximab in UC patients could be
related to subtherapeutic serum levels due to consumption of the antibody in
the mucosal bowel compartment. In patients with acute severe bowel inflammation
the circulating IFX level might therefore be lower.
Study objective
To get a better understanding of the pharmacokinetics of IFX in Ulcerative
Colitis, especially with regards to the circulating drug levels in the first 42
days after the start of therapy, and in relationship to the *inflammatory
burden* by Ulcerative Colitis.
Study design
Prospective observational multicenter study
Study burden and risks
Subjects will undergo several blood (15cc) and stool sample collections
(outpatient:11, hospitalized:14), 2 colonoscopies, 6 physical examinations and
questionnaires (SCCAI) will be taken in 11-14 distinct hospital visits.
Risks involved with colonoscopy and biopsies are perforation or bleeding.
Meibergdreef 9
1105 AZ Amsterdam
NL
Meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
-Age from 18 years, either male or female
-Moderate to severe Ulcerative Colitis (according to Mayo score (2 or 3) baseline Colonoscopy) naïve to biologic therapy.
-Baseline Colonoscopy
-Obtained written informed consent
Exclusion criteria
-History of anti-TNF treatment
-Contra-indication to infliximab: TBC, severe infections or congestive heart failure.
-Imminent need for surgery
-Immunomodulators started in the last 4 weeks
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 | NL39626.018.12 |