Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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 31, 2014
Last verified: October 2014
  Purpose

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.


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) State Scores From Baseline to After 6 Months of Treatment With Adalimumab [ Time Frame: Baseline and Visit 3 [Month 6] ] [ Designated as safety issue: No ]
    The STAI questionnaire consists of 40 questions with 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. The scores for each subtest range from 20 to 80, with higher scores indicating higher levels of anxiety.

  • Change in State Trait Anxiety Index (STAI) Trait Scores From Baseline to After 6 Months of Treatment With Adalimumab [ Time Frame: Baseline and Visit 3 [Month 6] ] [ Designated as safety issue: No ]
    The STAI questionnaire consists of 40 questions with 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. The scores for each subtest range from 20 to 80, with higher scores indicating higher levels of anxiety.

  • Change in Hospital Anxiety and Depression Score (HADS) - Anxiety, From Baseline to After 6 Months of Treatment With Adalimumab [ Time Frame: Baseline and Visit 3 [Month 6] ] [ Designated as safety issue: No ]
    HADS is used to detect emotional disturbances (such as anxiety and depression) in non-psychiatric patients treated at hospital clinics. It consists of 14 items with 7 items relating to anxiety and to depression respectively. Each item is scored from 0 to 3 therefore scores for each subscale range from 0 to 21 with higher scores indicating higher levels of anxiety and depression. The scores were categorized as follows: 0 to 7 was normal, 8 to 10 was suggestive, and 11 to 21 was case.

  • Change in Hospital Anxiety and Depression Score (HADS) - Depression, From Baseline to After 6 Months of Treatment With Adalimumab [ Time Frame: Baseline and Visit 3 [Month 6] ] [ Designated as safety issue: No ]
    HADS is used to detect emotional disturbances (such as anxiety and depression) in non-psychiatric patients treated at hospital clinics. It consists of 14 items with 7 items relating to anxiety and to depression respectively. Each item is scored from 0 to 3 therefore scores for each subscale range from 0 to 21 with higher scores indicating higher levels of anxiety and depression. The scores were categorized as follows: 0 to 7 was normal, 8 to 10 was suggestive, and 11 to 21 was case.


Secondary Outcome Measures:
  • Short Inflammatory Bowel Disease Questionnaire (sIBDQ) Scores by Visit [ Time Frame: Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6] ] [ Designated as safety issue: No ]
    The sIBDQ is a disease-specific health-related quality of life (HRQoL) questionnaire, able to detect and define meaningful clinical changes in inflammatory bowel disease (IBD) patients by measuring physical, social and emotional status. The sIBDQ consists of 10 questions, each question is scored on a scale from 1 (poor QoL) to 7 (good QoL). The scores are summed up and divided by 10 for a mean score ranging from 1 (poor QoL) to 7 (good QoL). A higher score indicates a better HRQoL.

  • Harvey-Bradshaw Index (HBI) Scores by Visit [ Time Frame: Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6] ] [ Designated as safety issue: No ]
    Harvey-Bradshaw Index (HBI) is for use in the assessment and quantification of symptoms and the present level of disease activity of patients with Crohn's disease. It is a validated clinical index for Crohn's disease, including the 5 categories of: general well-being, abdominal pain, number of liquid stools, abdominal mass and complications. The score ranges from 0 to 25 with higher scores indicating higher disease activity. The scores were classified as follows: less than 5 is remission, 5 to 7 is mild, 8 to 16 is moderate, and greater than 16 is severe.

  • State Trait Anxiety Index (STAI) State Scores by Visit [ Time Frame: Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6] ] [ Designated as safety issue: No ]
    The STAI questionnaire consists of 40 questions with 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. The scores for each subtest range from 20 to 80, with higher scores indicating higher levels of anxiety.

  • State Trait Anxiety Index (STAI) Trait Scores by Visit [ Time Frame: Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6] ] [ Designated as safety issue: No ]
    The STAI questionnaire consists of 40 questions with 20 items allocated to each of the State Anxiety and Trait Anxiety subscales. The scores for each subtest range from 20 to 80, with higher scores indicating higher levels of anxiety.

  • Hospital Anxiety and Depression Score (HADS) - Anxiety Scores by Visit [ Time Frame: Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6] ] [ Designated as safety issue: No ]
    HADS is used to detect emotional disturbances (such as anxiety and depression) in non-psychiatric patients treated at hospital clinics. It consists of 14 items with 7 items relating to anxiety and to depression respectively. Each item is scored from 0 to 3 therefore scores for each subscale range from 0 to 21 with higher scores indicating higher levels of anxiety and depression. The scores were categorized as follows: 0 to 7 was normal, 8 to 10 was suggestive, and 11 to 21 was case.

  • Hospital Anxiety and Depression Score (HADS) - Depression Scores by Visit [ Time Frame: Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6] ] [ Designated as safety issue: No ]
    HADS is used to detect emotional disturbances (such as anxiety and depression) in non-psychiatric patients treated at hospital clinics. It consists of 14 items with 7 items relating to anxiety and to depression respectively. Each item is scored from 0 to 3 therefore scores for each subscale range from 0 to 21 with higher scores indicating higher levels of anxiety and depression. The scores were categorized as follows: 0 to 7 was normal, 8 to 10 was suggestive, and 11 to 21 was case.


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 for whom adalimumab was prescribed in the usual manner in accordance with the terms of the local marketing authorization.

  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

The investigational sites were centers with a high level of experience in the treatment of Crohns disease patients.

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.
  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
Results First Received: October 2, 2014
Last Updated: October 31, 2014
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
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Mental Disorders
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014