CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 83 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT01428115
NCT01428115N/ACompleted

Reveal the Level of Anxiety in Patients With Crohn's Disease Receiving Adalimumab

AbbVie (prior sponsor, Abbott)·observational·Posted Sep 2, 2011·Updated Nov 3, 2014

In Brief

An observational study for Severe Crohn's Disease and Anxiety. Completed, enrolled 83 participants across 8 sites.

Detailed Summary

It has been shown that emotional health issues, such as state anxiety, are more prevalent in patients suffering from inflammatory bowel disease (IBD) compared to physically healthy subjects. Such findings have to be taken into consideration when making an educated guess that psychological factors such as depression and anxiety in particular interact with the course of Crohns disease. Therefore the treatment of the underlying disease may have a significant influence on the level of psychological disorders. Several studies have shown that treatment with tumor necrosis factor alpha (TNF-α) antibodies ameliorates the emotional/psychological status of patients, however the impact of adalimumab therapy on anxiety correlated with the status of inflammatory bowel disease (IBD) remains unclear. The primary objective of this study was to describe and evaluate changes in levels of anxiety assessed by validated patient questionnaires after 6 months of treatment with adalimumab.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesAustria
CollaboratorsRaffeiner GmbH

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 2, 2011
Enrollment StartDec 1, 2011
Primary CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 14.8 years ago