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

This study has been completed.
Sponsor:
Collaborator:
Raffeiner GmbH
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01428115
First received: September 1, 2011
Last updated: October 17, 2013
Last verified: October 2013
  Purpose

Our current study aims to primarily show an eventual positive effect on the anxiety level of patients as a result of being under therapy with Adalimumab for severe active Crohn's disease.

It has been shown that emotional health issues, such as state anxiety, is 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 Crohn's disease. Therefore the treatment of the underlying disease may have a significant influence on the level of psychological disorders.

As several studies have already proven to ameliorate the emotional / psychological status of patients such as Quality of Life and depression using TNFα-antibodies, the impact of adalimumab therapy on anxiety correlated with the status of IBD remains unclear.

Therefore it would be of high interest to evaluate the therapeutic benefit of Adalimumab on the level of anxiety, the correlation between the clinical and psychological improvement based on clinical assessment using validated scores and outcomes reported by patients using validated questionnaires.


Condition
Severe Crohn's Disease
Anxiety

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Reveal the Level of Anxiety in Patients With Crohn's Disease Receiving Adalimumab

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Change in State Trait Anxiety Index (STAI) from baseline (prior to treatment with adalimumab (Humira)) to after 6 months of treatment with adalimumab (Humira). [ Time Frame: month 6 ] [ Designated as safety issue: No ]
  • Change in Hospital Anxiety and Depression Score (HADS) from baseline (prior to treatment with adalimumab (Humira)) to after 6 months of treatment with adalimumab (Humira). [ Time Frame: month 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • short Inflammatory Bowel Disease Questionnaire - sIBDQ [ Time Frame: at baseline ] [ Designated as safety issue: No ]
  • short Inflammatory Bowel Disease Questionnaire - sIBDQ [ Time Frame: month 3 ] [ Designated as safety issue: No ]
  • short Inflammatory Bowel Disease Questionnaire - sIBDQ [ Time Frame: month 6 ] [ Designated as safety issue: No ]
  • Harvey-Bradshaw Index - HBI [ Time Frame: at baseline ] [ Designated as safety issue: No ]
  • Harvey-Bradshaw Index - HBI [ Time Frame: month 3 ] [ Designated as safety issue: No ]
  • Harvey-Bradshaw Index - HBI [ Time Frame: month 6 ] [ Designated as safety issue: No ]
  • State Trait Anxiety Index (STAI) [ Time Frame: at baseline ] [ Designated as safety issue: No ]
  • State Trait Anxiety Index (STAI) [ Time Frame: month 3 ] [ Designated as safety issue: No ]
  • State Trait Anxiety Index (STAI) [ Time Frame: month 6 ] [ Designated as safety issue: No ]
  • Hospital Anxiety and Depression Score (HADS) [ Time Frame: at baseline ] [ Designated as safety issue: No ]
  • Hospital Anxiety and Depression Score (HADS) [ Time Frame: month 3 ] [ Designated as safety issue: No ]
  • Hospital Anxiety and Depression Score (HADS) [ Time Frame: month 6 ] [ Designated as safety issue: No ]

Enrollment: 83
Study Start Date: December 2011
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with severe active Crohn's disease
Patients with severe active Crohn's disease

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Hospital

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 Crohn's Disease, attending a routine medical visit.
    • Able to complete questionnaires.
    • Patients with status active severe Crohn's disease which required immunosuppressive treatment
    • Patients must fulfil international and national guidelines for the use of a biologic therapies in Crohn's 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

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 Summary of Product Characteristics
    • Current or planned pregnancy
    • Lactation according to Summary of Product Characteristics
    • Planned change of site within the next 24 weeks.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01428115

Locations
Austria
Site Reference ID/Investigator# 64830
Graz, Austria, 8036
Site Reference ID/Investigator# 64832
Innsbruck, Austria, 6020
Site Reference ID/Investigator# 64829
Linz, Austria, A-4010
Site Reference ID/Investigator# 64831
Salzburg, Austria, A-5020
Site Reference ID/Investigator# 64828
St. Poelten, Austria, 3100
Site Reference ID/Investigator# 79613
St. Veit/Glan, Austria, 9300
Site Reference ID/Investigator# 47342
Vienna, Austria, 1030
Site Reference ID/Investigator# 64833
Vienna, Austria, 1090
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Raffeiner GmbH
Investigators
Study Director: Astrid Dworan-Timler, MD AbbVie Austria
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01428115     History of Changes
Other Study ID Numbers: P12-705
Study First Received: September 1, 2011
Last Updated: October 17, 2013
Health Authority: Austria: Federal Office for Safety in Health Care

Keywords provided by AbbVie:
monoclonal
anxiety
antibodies
adalimumab
severe crohn's disease
quality of life
biological products

Additional relevant MeSH terms:
Anxiety Disorders
Crohn Disease
Mental Disorders
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Adalimumab
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 18, 2014