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

Study Identifier
P12-705
CT.gov Identifier
NCT01428115
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Scientific Result Summary
Available Language(s): English
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Study Details

Medical Condition
  • Crohn's Disease (CD)
  • Anxiety
    • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    18 - 65 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * 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 Criteria:
    * 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.

    Protocol 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 Locations

    Location
    Status
    Location
    Site Reference ID/Investigator# 64830
    Graz, Austria, 8036
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 64832
    Innsbruck, Austria, 6020
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 64829
    Linz, Austria, A-4010
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 79613
    Saint Veit/Glan, Austria, 9300
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 64831
    Salzburg, Austria, A-5020
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 64828
    Sankt Pölten, Austria, 3100
    Status
    Not applicable
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