Clinical trial NCT01428115: Reveal the Level of Anxiety in Patients With Crohn's Disease Receiving Adalimumab
Official title: Reveal the Level of Anxiety in Patients With Crohn's Disease Receiving Adalimumab
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Crohn's Disease
Anxiety
Keywords: monoclonal
anxiety
antibodies
adalimumab
severe crohn's disease
quality of life
biological products
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: Raffeiner GmbH
First posted: 2011-09-02
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigational sites were centers with a high level of experience in the treatment of Crohns disease patients.

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 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.


Eligibility 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.

Primary outcomes:
measure: Change in State Trait Anxiety Index (STAI) State Scores From Baseline to After 6 Months of Treatment With Adalimumab
timeFrame: Baseline and Visit 3 [Month 6]
measure: Change in State Trait Anxiety Index (STAI) Trait Scores From Baseline to After 6 Months of Treatment With Adalimumab
timeFrame: Baseline and Visit 3 [Month 6]
measure: Change in Hospital Anxiety and Depression Score (HADS) - Anxiety, From Baseline to After 6 Months of Treatment With Adalimumab
timeFrame: Baseline and Visit 3 [Month 6]
measure: Change in Hospital Anxiety and Depression Score (HADS) - Depression, From Baseline to After 6 Months of Treatment With Adalimumab
timeFrame: Baseline and Visit 3 [Month 6]
Secondary outcomes:
measure: Short Inflammatory Bowel Disease Questionnaire (sIBDQ) Scores by Visit
timeFrame: Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]
measure: Harvey-Bradshaw Index (HBI) Scores by Visit
timeFrame: Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]
measure: State Trait Anxiety Index (STAI) State Scores by Visit
timeFrame: Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]
measure: State Trait Anxiety Index (STAI) Trait Scores by Visit
timeFrame: Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]
measure: Hospital Anxiety and Depression Score (HADS) - Anxiety Scores by Visit
timeFrame: Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]
measure: Hospital Anxiety and Depression Score (HADS) - Depression Scores by Visit
timeFrame: Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Site Reference ID/Investigator# 64830
city: Innsbruck
country: Austria
facility: Site Reference ID/Investigator# 64832
city: Linz
country: Austria
facility: Site Reference ID/Investigator# 64829
city: Salzburg
country: Austria
facility: Site Reference ID/Investigator# 64831
city: St. Poelten
country: Austria
facility: Site Reference ID/Investigator# 64828
city: St. Veit/Glan
country: Austria
facility: Site Reference ID/Investigator# 79613
city: Vienna
country: Austria
facility: Site Reference ID/Investigator# 47342
city: Vienna
country: Austria
facility: Site Reference ID/Investigator# 64833
Study officials:
affiliation: AbbVie Austria
name: Astrid Dworan-Timler, MD
role: STUDY_DIRECTOR
References: