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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 9 January 2017
Main ID:  NCT02073526
Date of registration: 09/01/2014
Prospective Registration: No
Primary sponsor: Oslo University Hospital
Public title: Anti-TNF-alpha Trough Level Measurements in Inflammatory Bowel Disease
Scientific title: Anti-TNF-alpha Trough Level Measurements in Inflammatory Bowel Disease
Date of first enrolment: May 2013
Target sample size: 1230
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02073526
Study type:  Observational [Patient Registry]
Study design:  Observational Model: Cohort, Time Perspective: Prospective  
Phase:  N/A
Countries of recruitment
Norway
Contacts
Name:     Knut EA Lundin, Prof.
Address: 
Telephone:
Email:
Affiliation:  Oslo University Hospital
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Crohn's Disease
Inflammatory Bowel Disease
Ulcerative Colitis
Intervention(s)
Drug: Infliximab, adalimumab, certolizumab pegol
Primary Outcome(s)
Measurement of drug serum concentrations [Time Frame: Serum samples will be collected on average 8 weeks (range 0-90 days) after drug administration]
Secondary Outcome(s)
Assay validation [Time Frame: December 2013 - March 2014]
Change in individuals drug serum concentration [Time Frame: Serum samples will be collected on average 8 weeks (range 0-90 days) after drug administration]
Measure soluble TNF-receptor in serum [Time Frame: Measurement will be conducted in 2015 on blood samples stored in a bio-bank]
Secondary ID(s)
2013-1352
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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