Clinical trial NCT02073526: Anti-TNF-alpha Trough Level Measurements in Inflammatory Bowel Disease
Official title: Anti-TNF-alpha Trough Level Measurements in Inflammatory Bowel Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Disease
Crohn's Disease
Ulcerative Colitis
Keywords: Antibodies, Monoclonal
Anti-TNF
TNF-alpha
Trough level
Drug concentration
ELISA
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2014-02-27
Enrollment: 1230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Inflammatory bowel disease treated with anti-TNF drug

Brief summary: Drug serum concentrations will be measured at several time-points for inflammatory disease patients treated with anti-TNF agents. The purpose is to determine which patients that will clinically benefit from either discontinue treatment, adjusting the dose, switch to another anti-TNF agent or a different class of medication.

Detailed description: Crohn´s disease and ulcerative colitis are diseases where the proinflammatory cytokine Tumor Necrosis Factor-alpha (TNF) plays an important role. Anti-TNF agents are used in the treatment. However, some patients do not respond and response rates declines over time. The cause may be immunogenicity against the agent itself, the agent´s failure to neutralize TNF or another biological pathway leading to inflammation. Anti-TNF agents have been administrated as fixed doses at certain frequencies and this may not be optimal for all patients, but recent studies have indicated a correlation between efficacy and serum drug concentration levels (trough levels). Our preliminary data suggest that trough levels early in the treatment course may be predictive of later trough levels. By multiple measurements, this will be assessed. The study will also investigate biological markers in serum and blood cells which may be predictable for trough levels. Finally, we will compare different methods to measure serum drug concentrations.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with Inflammatory bowel disease
* Treated with anti-TNF drug
* Follow-up at specialized gastroenterologist in Norway
* Age 18 or over

Exclusion Criteria:

* Patients refusing to participate by not giving their informed consent

Primary outcomes:
measure: Measurement of drug serum concentrations
timeFrame: Serum samples will be collected on average 8 weeks (range 0-90 days) after drug administration
Secondary outcomes:
measure: Measure soluble TNF-receptor in serum
timeFrame: Measurement will be conducted in 2015 on blood samples stored in a bio-bank
measure: Assay validation
timeFrame: December 2013 - March 2014
measure: Change in individuals drug serum concentration
timeFrame: Serum samples will be collected on average 8 weeks (range 0-90 days) after drug administration
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Rikshospitalet-Radiumhospitalet HF, Oslo University Hospital
state: Postboks PB 4950 Nydalen
Study officials:
affiliation: Oslo University Hospital
name: Knut EA Lundin, Prof.
role: PRINCIPAL_INVESTIGATOR
References: