Crohn's Disease, Inflammatory Bowel Disease, Ulcerative Colitis
Conditions
Keywords
Antibodies, Monoclonal, Anti-TNF, TNF-alpha, Trough level, Drug concentration, ELISA
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.
Interventions
DRUGInfliximab, adalimumab, certolizumab pegol
Patients are treated with the above mentioned drugs decided by clinicians
Sponsors
Oslo University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of drug serum concentrations | Serum samples will be collected on average 8 weeks (range 0-90 days) after drug administration | Drug serum concentration will be measured using an ELISA |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measure soluble TNF-receptor in serum | Measurement will be conducted in 2015 on blood samples stored in a bio-bank | — |
| Assay validation | December 2013 - March 2014 | Drug concentration measurements will be conducted with ELISA's with monoclonal and polyclonal antibodies, automated immunofluorometric assay and commercial kits for the purpose to validate tests and establish standards for measurements |
| Change in individuals drug serum concentration | Serum samples will be collected on average 8 weeks (range 0-90 days) after drug administration | Intra-individual fluctuations in consecutively measurements during a course of treatment will be measured. |
Countries
Norway
Outcome results
None listed