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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Oslo University Hospital
Information provided by (Responsible Party):
Oslo University Hospital Identifier:
First received: January 9, 2014
Last updated: February 25, 2014
Last verified: February 2014
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 Intervention
Inflammatory Bowel Disease
Crohn's Disease
Ulcerative Colitis
Drug: Infliximab, adalimumab, certolizumab pegol

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Anti-TNF-alpha Trough Level Measurements in Inflammatory Bowel Disease

Resource links provided by NLM:

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Measurement of drug serum concentrations [ Time Frame: Serum samples will be collected on average 8 weeks (range 0-90 days) after drug administration ] [ Designated as safety issue: No ]
    Drug serum concentration will be measured using an ELISA

Secondary Outcome Measures:
  • Measure soluble TNF-receptor in serum [ Time Frame: Measurement will be conducted in 2015 on blood samples stored in a bio-bank ] [ Designated as safety issue: No ]
  • Assay validation [ Time Frame: December 2013 - March 2014 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Serum samples will be collected on avaerage 8 weeks (range 0-90 days) after drug administration ] [ Designated as safety issue: No ]
    Intra-individual fluctuations in consecutively measurements during a course of treatment will be measured.

Biospecimen Retention:   Samples With DNA
Serum, whole blood

Estimated Enrollment: 1300
Study Start Date: May 2013
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02073526

Contact: Knut EA Lundin, Prof.
Contact: Magne Rekvig, MD

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

Responsible Party: Oslo University Hospital Identifier: NCT02073526     History of Changes
Other Study ID Numbers: 2013-1352 
Study First Received: January 9, 2014
Last Updated: February 25, 2014
Health Authority: Norway: Regional Ethics Commitee
Norway: Norwegian Medicines Agency
Norway: Norwegian Social Science Data Services
Norway: Directorate of Health

Keywords provided by Oslo University Hospital:
Antibodies, Monoclonal
Trough level
Drug concentration

Additional relevant MeSH terms:
Inflammatory Bowel Diseases
Colitis, Ulcerative
Crohn Disease
Intestinal Diseases
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Certolizumab Pegol
Antirheumatic Agents
Immunologic Factors
Immunosuppressive Agents
Physiological Effects of Drugs processed this record on May 25, 2016