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

Completed

• Conditions: Inflammatory Bowel Disease; Crohn's Disease; Ulcerative Colitis
• Interventions: Drug: Infliximab, adalimumab, certolizumab pegol

• Registration Number: NCT02073526
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2014-01-09
• Study First Submitted QC: 2014-02-25
• Study First Posted: 2014-02-27
• Primary Completion: 2016-05
• Study Completion: 2016-11
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-05
• Last Update Posted: 2016-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1230

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Anti-TNF	Infliximab, adalimumab, certolizumab pegol	Inflammatory bowel patients age 18 and over treated with anti-TNF agents

Primary Outcome Measures

Name	Time	Method
Measurement of drug serum concentrations	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

Name	Time	Method
Change in individuals drug serum concentration	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.
Measure soluble TNF-receptor in serum	Measurement will be conducted in 2015 on blood samples stored in a bio-bank
Assay validation	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

Trial Locations

Locations (1)

Rikshospitalet-Radiumhospitalet HF, Oslo University Hospital; 🇳🇴 Oslo, Postboks PB 4950 Nydalen, Norway