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NCT02322008 Clinical Trial

Anti-TNF Therapy in Danish Patients With Inflammatory Bowel Diseases in Clinical Practice

Ulcerative Colitis Clinical Trial

Official title:
Anti-TNF Therapy in Danish Patients With Inflammatory Bowel Diseases in Clinical Practice

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02322008
Other study ID # Anti-TNF, IBD
Secondary ID
Status Completed
Phase N/A
First received December 17, 2014
Last updated December 22, 2014
Start date September 2009
Est. completion date March 2011

Study information
Verified date December 2014
Source Regionshospitalet Viborg, Skive
Contact n/a
Is FDA regulated No
Health authority De Videnskabsetiske Komitéer for Region Midtjylland: Denmark
Study type Observational

Clinical Trial Summary

Can genetic markers be used to predict anti-TNF response? A cohort was established to identify SNPs associated with anti-TNF therapy in patients with inflammatory bowel disease.

Recruitment information / eligibility
Status Completed
Enrollment 1035
Est. completion date March 2011
Est. primary completion date March 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- CD or UC, treated with anti-TNF

Exclusion Criteria:

- Missing data

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Biological:
• infliximab and adalimumab
In this retrospective, observational study, no interventions were undertaken by the researchers.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Regionshospitalet Viborg, Skive

Outcome
Type Measure Description Time frame Safety issue
Primary 3-step scale Best response within 22 weeks 22 weeks No
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