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

Study Overview
=================
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.

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

Conditions
-----------------
Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis

Intervention / Treatment
-----------------
* Drug: Infliximab, adalimumab, certolizumab pegol


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Anti-TNF<br>Inflammatory bowel patients age 18 and over treated with anti-TNF agents | Drug: Infliximab, adalimumab, certolizumab pegol<br>* Patients are treated with the above mentioned drugs decided by clinicians<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure soluble TNF-receptor in serum |  | Measurement will be conducted in 2015 on blood samples stored in a bio-bank | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antibodies, Monoclonal, Anti-TNF, TNF-alpha, Trough level, Drug concentration, ELISA