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

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ClinicalTrials.gov Identifier: NCT02073526
Recruitment Status : Completed
First Posted : February 27, 2014
Last Update Posted : December 6, 2016
Information provided by (Responsible Party):
Knut E. A. Lundin, Oslo University Hospital

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.

Condition or disease Intervention/treatment
Inflammatory Bowel Disease Crohn's Disease Ulcerative Colitis Drug: Infliximab, adalimumab, certolizumab pegol

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 1230 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Anti-TNF-alpha Trough Level Measurements in Inflammatory Bowel Disease
Study Start Date : May 2013
Actual Primary Completion Date : May 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Inflammatory bowel patients age 18 and over treated with anti-TNF agents
Drug: Infliximab, adalimumab, certolizumab pegol
Patients are treated with the above mentioned drugs decided by clinicians

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Biospecimen Retention:   Samples With DNA
Serum, whole blood

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Inflammatory bowel disease treated with anti-TNF drug

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02073526

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Rikshospitalet-Radiumhospitalet HF, Oslo University Hospital
Oslo, Postboks PB 4950 Nydalen, Norway, 0424
Sponsors and Collaborators
Oslo University Hospital
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Principal Investigator: Knut EA Lundin, Prof. Oslo University Hospital
Additional Information:

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Responsible Party: Knut E. A. Lundin, Professor, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02073526    
Other Study ID Numbers: 2013-1352
First Posted: February 27, 2014    Key Record Dates
Last Update Posted: December 6, 2016
Last Verified: December 2016
Keywords provided by Knut E. A. Lundin, Oslo University Hospital:
Antibodies, Monoclonal
Trough level
Drug concentration
Additional relevant MeSH terms:
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Crohn Disease
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Certolizumab Pegol
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs