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

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02073526
• Other study ID #: 2013-1352
• Status: Completed
• Phase: N/A
• First received: January 9, 2014
• Last updated: December 5, 2016
• Start date: May 2013
• Est. completion date: November 2016

Study information

• Verified date: December 2016
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Regional Ethics CommiteeNorway: Norwegian Medicines AgencyNorway: Norwegian Social Science Data ServicesNorway: Directorate of Health
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1230
• Est. completion date: November 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colitis, Ulcerative
• Crohn Disease
• Crohn's Disease
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcerative Colitis

Intervention

Drug:
• Infliximab, adalimumab, certolizumab pegol
Patients are treated with the above mentioned drugs decided by clinicians

Locations

Country	Name	City	State
Norway	Rikshospitalet-Radiumhospitalet HF, Oslo University Hospital	Oslo	Postboks PB 4950 Nydalen

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of drug serum concentrations	Drug serum concentration will be measured using an ELISA	Serum samples will be collected on average 8 weeks (range 0-90 days) after drug administration	No
Secondary	Measure soluble TNF-receptor in serum		Measurement will be conducted in 2015 on blood samples stored in a bio-bank	No
Secondary	Assay validation	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	December 2013 - March 2014	No
Secondary	Change in individuals drug serum concentration	Intra-individual fluctuations in consecutively measurements during a course of treatment will be measured.	Serum samples will be collected on average 8 weeks (range 0-90 days) after drug administration	No