Status:
COMPLETED
Reveal the Level of Anxiety in Patients With Crohn's Disease Receiving Adalimumab
Lead Sponsor:
AbbVie (prior sponsor, Abbott)
Collaborating Sponsors:
Raffeiner GmbH
Conditions:
Severe Crohn's Disease
Anxiety
Eligibility:
All Genders
18-65 years
Brief 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 fin...
Eligibility Criteria
Inclusion
- Patients for whom Adalimumab (Humira) therapy is indicated and has been prescribed according to the product label and who meet the following criteria:
- Male and female patients aged 18 to 65 years suffering from severe active Crohns Disease, attending a routine medical visit.
- Able to complete questionnaires.
- Patients with status active severe Crohns disease which required immunosuppressive treatment
- Patients must fulfil international and national guidelines for the use of a biologic therapies in Crohns Disease (Chest X-ray and interferon gamma release assay (IGRA) or PPD (purified protein derivative)-skin test negative for tuberculosis).
- Patients have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.
- Patients who have been prescribed in line with the European Summary of Product Characteristics (SMPC)
Exclusion
- The following patients will not be included in this observational study:
- Previous therapy with TNF-α blocker within the last 8 weeks
- Active Central Nervous System opportunistic infections or Central Nervous System malignancies.
- History of Cerebrovascular Accident
- Abuse of illicit substances (such as psychoactive drugs) within the previous 3 months
- Change of medication-based treatment of generalized anxiety and panic disorder, psychiatric disorder
- No informed consent
- Contraindication to adalimumab (Humira) therapy according to the SMPC
- Current or planned pregnancy
- Lactation according to SMPC
- Planned change of site within the next 24 weeks.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT01428115
Start Date
December 1 2011
End Date
October 1 2013
Last Update
November 3 2014
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Site Reference ID/Investigator# 64830
Graz, Austria, 8036
2
Site Reference ID/Investigator# 64832
Innsbruck, Austria, 6020
3
Site Reference ID/Investigator# 64829
Linz, Austria, A-4010
4
Site Reference ID/Investigator# 79613
Saint Veit/Glan, Austria, 9300