Rikshospitalet-Radiumhospitalet HF, Oslo University Hospital
Oslo, Postboks PB 4950 Nydalen, 0424, Norway
NCT Number: NCT02073526
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.
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Notify Me18 year and older
All sexes
Observational
Oslo, Postboks PB 4950 Nydalen, 0424, Norway
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients are treated with the above mentioned drugs decided by clinicians
Time frame: 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
Time frame: Measurement will be conducted in 2015 on blood samples stored in a bio-bank
Time frame: 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
Time frame: 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.
Oslo University Hospital
Other
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