Severe Crohn's DiseaseRELAXNCT01428115

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

An observational study of Severe Crohn's Disease and Anxiety, run by AbbVie (prior sponsor, Abbott) at 8 sites in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Severe Crohn's Disease, Anxiety
How many people: 83 participants
Where: 8 sitesAustria
Study dates: Dec 2011to Oct 2013
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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)

Who cannot join

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

Show all 11Show fewer

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.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

Austria8 sites

Site Reference ID/Investigator# 64830
Graz, 8036
Site Reference ID/Investigator# 64832
Innsbruck, 6020
Site Reference ID/Investigator# 64829
Linz, A-4010
Site Reference ID/Investigator# 79613
Saint Veit/Glan, 9300
Site Reference ID/Investigator# 64831
Salzburg, A-5020
Site Reference ID/Investigator# 64828
Sankt Pölten, 3100
Site Reference ID/Investigator# 47342
Vienna, 1030
Site Reference ID/Investigator# 64833
Vienna, 1090

Other trials in Austria

About this study

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
Medical subject headings: Crohn Disease, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01428115
Study group	Role	What they receive
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and Visit 3 [Month 6]

Secondary outcomes (6)

Short Inflammatory Bowel Disease Questionnaire (sIBDQ) Scores by Visit
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.
Measured: Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]
Harvey-Bradshaw Index (HBI) Scores by Visit
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.
Measured: Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]
State Trait Anxiety Index (STAI) State Scores by Visit
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.
Measured: Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]
State Trait Anxiety Index (STAI) Trait Scores by Visit
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.
Measured: Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]
Hospital Anxiety and Depression Score (HADS) - Anxiety Scores by Visit
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.
Measured: Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]
Hospital Anxiety and Depression Score (HADS) - Depression Scores by Visit
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.
Measured: Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2011Oct 2013

First posted2 Sep 2011 (estimated)
Study startDec 2011
Primary completionOct 2013
Study completionOct 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Severe Crohn's DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 83 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01428115
Sponsor's protocol ID: P12-705
Acronym: RELAX
Status last verified: Oct 2014
First submitted: 1 Sep 2011
Last updated: 3 Nov 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Severe Crohn's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Reveal the Level of Anxiety in Patients With Crohn's Disease Receiving Adalimumab
ClinicalTrials.gov ID: NCT01428115
Acronym / sponsor ID: RELAX / P12-705
Conditions: Severe Crohn's Disease, Anxiety
Keywords: monoclonal, anxiety, antibodies, adalimumab, severe crohn's disease, quality of life, biological products
Study type: Observational
Recruitment status: Completed
Enrolment: 83 participants (actual)
Lead sponsor: AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
Collaborators: Raffeiner GmbH
Study start: Dec 2011
Primary completion: Oct 2013 (actual)
Study completion: Oct 2013 (actual)
First posted: 2 Sep 2011 (estimated)
Results: Posted 3 Nov 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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 design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: The investigational sites were centers with a high level of experience in the treatment of Crohns disease patients.

Key inclusion criteria (7 listed)

Patients for whom Adalimumab (Humira) therapy is indicated and has been prescribed according to the product label and who meet the following criteria:

Key exclusion criteria (11 listed)

The following patients will not be included in this observational study:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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]
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]
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]
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]
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.

6 secondary outcomes

Short Inflammatory Bowel Disease Questionnaire (sIBDQ) Scores by Visit
Time frame: Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]
Harvey-Bradshaw Index (HBI) Scores by Visit
Time frame: Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]
State Trait Anxiety Index (STAI) State Scores by Visit
Time frame: Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]
State Trait Anxiety Index (STAI) Trait Scores by Visit
Time frame: Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]
Hospital Anxiety and Depression Score (HADS) - Anxiety Scores by Visit
Time frame: Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]
Hospital Anxiety and Depression Score (HADS) - Depression Scores by Visit
Time frame: Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6]

Results and safety

Results posted to the registry on 3 Nov 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Adalimumab	83	62

Primary outcome: 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]. Mean (Standard Deviation). Unit: scores on a scale

Measure	Adalimumab n = 59
Value	-1.7 (9.8)

Population analysed: All data were analyzed as observed and missing values were not replaced by any imputation method. In analyses of changes between visits, only patients with values at both visits were include.

Primary outcome: 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]. Mean (Standard Deviation). Unit: scores on a scale

Measure	Adalimumab n = 57
Value	-9.0 (9.2)

Primary outcome: 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]. Number. Unit: participants

Measure	Adalimumab n = 59
Normal to Normal	33
Normal to Suggestive	5
Normal to Case	2
Suggestive to Normal	5
Suggestive to Suggestive	7
Suggestive to Case	0
Case to Normal	1
Case to Suggestive	2

Primary outcome: 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]. Number. Unit: participants

Measure	Adalimumab n = 59
Normal to Normal	47
Normal to Suggestive	8
Normal to Case	0
Suggestive to Normal	0
Suggestive to Suggestive	2
Suggestive to Case	0
Case to Normal	1
Case to Suggestive	1

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the time of informed consent up to 70 days following the intake of the last dose of physician-prescribed treatment. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adalimumab	9 of 83 (10.8%)	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Astrid Dworan-Timler, MD study director

AbbVie Austria

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Severe Crohn's Disease and Anxiety, run by AbbVie (prior sponsor, Abbott) at 8 sites in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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]). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01428115.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2014.