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OpenTrials
Completed

NCT Number: NCT02073526

Anti-TNF-alpha Trough Level Measurements in Inflammatory Bowel Disease

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rikshospitalet-Radiumhospitalet HF, Oslo University Hospital

Oslo, Postboks PB 4950 Nydalen, 0424, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Infliximab, adalimumab, certolizumab pegol

Drug

Patients are treated with the above mentioned drugs decided by clinicians

Primary outcomes

  1. Measurement of drug serum concentrations

    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

Secondary outcomes

  1. Measure soluble TNF-receptor in serum

    Time frame: Measurement will be conducted in 2015 on blood samples stored in a bio-bank

  2. Assay validation

    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

  3. Change in individuals drug serum concentration

    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.

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Feb 27, 2014
Registry last updated
Dec 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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