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

NCT01428115 | Completed Results

• 1 other identifier: P12-705
• Study Type: observational
• Target: 83
• Locations: 1 country
• Sites: 8

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.

Conditions

Severe Crohn's Disease; Anxiety

Keywords

monoclonal; anxiety; antibodies; adalimumab; severe crohn's disease; quality of life; biological products

Outcome Measures

Primary Outcomes (4)

• Change in State Trait Anxiety Index (STAI) State Scores From Baseline to After 6 Months of Treatment With Adalimumab

  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.

  Baseline and Visit 3 [Month 6]

• Change in State Trait Anxiety Index (STAI) Trait Scores From Baseline to After 6 Months of Treatment With Adalimumab

  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.

  Baseline and Visit 3 [Month 6]

• Change in Hospital Anxiety and Depression Score (HADS) - Anxiety, From Baseline to After 6 Months of Treatment With Adalimumab

  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.

  Baseline and Visit 3 [Month 6]

• Change in Hospital Anxiety and Depression Score (HADS) - Depression, From Baseline to After 6 Months of Treatment With Adalimumab

  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.

  Baseline and Visit 3 [Month 6]

Secondary Outcomes (6)

• Short Inflammatory Bowel Disease Questionnaire (sIBDQ) Scores by Visit

  Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]

• Harvey-Bradshaw Index (HBI) Scores by Visit

  Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]

• State Trait Anxiety Index (STAI) State Scores by Visit

  Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]

• State Trait Anxiety Index (STAI) Trait Scores by Visit

  Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]

• Hospital Anxiety and Depression Score (HADS) - Anxiety Scores by Visit

  Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]

Study Arms (1)

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 Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead
• Raffeiner GmbH: collaborator

Study Sites (8)

Site Reference ID/Investigator# 64830

Graz, 8036, Austria

Location

Site Reference ID/Investigator# 64832

Innsbruck, 6020, Austria

Location

Site Reference ID/Investigator# 64829

Linz, A-4010, Austria

Location

Site Reference ID/Investigator# 79613

Saint Veit/Glan, 9300, Austria

Location

Site Reference ID/Investigator# 64831

Salzburg, A-5020, Austria

Location

Site Reference ID/Investigator# 64828

Sankt Pölten, 3100, Austria

Location

Site Reference ID/Investigator# 47342

Vienna, 1030, Austria

Location

Site Reference ID/Investigator# 64833

Vienna, 1090, Austria

Location

Related Links

• Related Info

MeSH Terms

Conditions

Crohn Disease; Anxiety Disorders

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Mental Disorders

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie (prior sponsor, Abbott)

800-633-9110

Study Officials

• Astrid Dworan-Timler, MD

  AbbVie Austria

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2011
• First Posted: September 2, 2011
• Study Start: December 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: November 3, 2014
• Results First Posted: November 3, 2014

Record last verified: 2014-10

Locations

AU (8)