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

NCT ID: NCT02073526

Last Updated: 2016-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1230 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-31

Study Completion Date

2016-11-30

Brief Summary

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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

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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.

Conditions

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Inflammatory Bowel Disease Crohn's Disease Ulcerative Colitis

Keywords

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Antibodies, Monoclonal Anti-TNF TNF-alpha Trough level Drug concentration ELISA

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Anti-TNF

Inflammatory bowel patients age 18 and over treated with anti-TNF agents

Infliximab, adalimumab, certolizumab pegol

Intervention Type DRUG

Patients are treated with the above mentioned drugs decided by clinicians

Interventions

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Infliximab, adalimumab, certolizumab pegol

Patients are treated with the above mentioned drugs decided by clinicians

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Knut E. A. Lundin

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Knut EA Lundin, Prof.

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

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Rikshospitalet-Radiumhospitalet HF, Oslo University Hospital

Oslo, Postboks PB 4950 Nydalen, Norway

Site Status

Countries

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Norway

Other Identifiers

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2013-1352

Identifier Type: -

Identifier Source: org_study_id