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

NCT02073526 | Completed

• 1 other identifier: 2013-1352
• Study Type: observational
• Target: 1,230
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Disease; Crohn's Disease; Ulcerative Colitis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• Change in individuals drug serum concentration

  Serum samples will be collected on average 8 weeks (range 0-90 days) after drug administration

Study Arms (1)

Anti-TNF

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

Drug: Infliximab, adalimumab, certolizumab pegol

Interventions

Infliximab, adalimumab, certolizumab pegol DRUG

Patients are treated with the above mentioned drugs decided by clinicians

Anti-TNF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Inflammatory bowel disease treated with anti-TNF drug

You may qualify if:

• Patients diagnosed with Inflammatory bowel disease
• Treated with anti-TNF drug
• Follow-up at specialized gastroenterologist in Norway
• Age 18 or over

You may not qualify if:

• Patients refusing to participate by not giving their informed consent

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Rikshospitalet-Radiumhospitalet HF, Oslo University Hospital

Oslo, Postboks PB 4950 Nydalen, 0424, Norway

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum, whole blood

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Interventions

Infliximab; Adalimumab; Certolizumab Pegol

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Antibodies, Monoclonal, Humanized; Polyethylene Glycols; Polymers; Macromolecular Substances; Immunoglobulin Fab Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides

Study Officials

• Knut EA Lundin, Prof.

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 9, 2014
• First Posted: February 27, 2014
• Study Start: May 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: November 1, 2016
• Last Updated: December 6, 2016

Record last verified: 2016-12

Locations

NO (1)