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

• 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.
• 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

Ulcerative Colitis

Inflammatory Bowel Disease

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)

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]

Assay validation [Time Frame: December 2013 - March 2014]

Secondary ID(s)

2013-1352

Source(s) of Monetary Support

Please refer to primary and secondary sponsors