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| Name | Class |
|---|---|
| Raffeiner GmbH | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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:
Exclusion Criteria:
The following patients will not be included in this observational study:
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The investigational sites were centers with a high level of experience in the treatment of Crohns disease patients.
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| Name | Affiliation | Role |
|---|---|---|
| Astrid Dworan-Timler, MD | AbbVie Austria | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 64830 | Graz | 8036 | Austria | |||
| Site Reference ID/Investigator# 64832 |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Adalimumab | Participants received 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Adalimumab | Participants received 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and Visit 3 [Month 6] |
|
From the time of informed consent up to 70 days following the intake of the last dose of physician-prescribed treatment
Only Serious Adverse Events were required to collect, therefore other Adverse Events were not collected
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adalimumab | 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie (prior sponsor, Abbott) | 800-633-9110 |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Baseline and Visit 3 [Month 6] |
| 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. | 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. | 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. | 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. | 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. | Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6] |
| Innsbruck |
| 6020 |
| Austria |
| Site Reference ID/Investigator# 64829 | Linz | A-4010 | Austria |
| Site Reference ID/Investigator# 79613 | Saint Veit/Glan | 9300 | Austria |
| Site Reference ID/Investigator# 64831 | Salzburg | A-5020 | Austria |
| Site Reference ID/Investigator# 64828 | Sankt Pölten | 3100 | Austria |
| Site Reference ID/Investigator# 47342 | Vienna | 1030 | Austria |
| Site Reference ID/Investigator# 64833 | Vienna | 1090 | Austria |
| Protocol Violation |
|
| Withdrawal by Subject |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants with Comorbidities | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and Visit 3 [Month 6] |
|
|
|
| Primary | 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. | 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. | Posted | Number | participants | Baseline and Visit 3 [Month 6] |
|
|
|
| Primary | 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. | 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. | Posted | Number | participants | Baseline and Visit 3 [Month 6] |
|
|
|
| Secondary | 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. | All data were analyzed as observed and missing values were not replaced by any imputation method. | Posted | Mean | Standard Deviation | scores on a scale | Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6] |
|
|
|
| Secondary | 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. | All data were analyzed as observed and missing values were not replaced by any imputation method. | Posted | Number | participants | Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6] |
|
|
|
| Secondary | 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. | All data were analyzed as observed and missing values were not replaced by any imputation method. | Posted | Mean | Standard Deviation | scores on a scale | Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6] |
|
|
|
| Secondary | 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. | All data were analyzed as observed and missing values were not replaced by any imputation method. | Posted | Mean | Standard Deviation | scores on a scale | Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6] |
|
|
|
| Secondary | 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. | All data were analyzed as observed and missing values were not replaced by any imputation method. | Posted | Number | participants | Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6] |
|
|
|
| Secondary | 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. | All data were analyzed as observed and missing values were not replaced by any imputation method. | Posted | Number | participants | Visit 1 [Baseline], Visit 2 [Month 3], and Visit 3 [Month 6] |
|
|
|
| 9 |
| 83 |
| 0 |
| 0 |
| Hyperemesis gravidarum | Pregnancy, puerperium and perinatal conditions | MedDRA 17.0 | Systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Bone lesion | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
|
| Drug ineffective | General disorders | MedDRA 17.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
|
| Anal Abscess | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
| Crohn's disease | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| D007410 | Intestinal Diseases |
| D001523 | Mental Disorders |
| Title | Measurements |
|---|---|
|
| Suggestive to Normal |
|
| Suggestive to Suggestive |
|
| Suggestive to Case |
|
| Case to Normal |
|
| Case to Suggestive |
|
| Case to Case |
|
| Title | Measurements |
|---|---|
|
| Suggestive to Normal |
|
| Suggestive to Suggestive |
|
| Suggestive to Case |
|
| Case to Normal |
|
| Case to Suggestive |
|
| Case to Case |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Visit 1: Severe [N=76] |
|
| Visit 2: Remission [N=50] |
|
| Visit 2: Mild [N=50] |
|
| Visit 2: Moderate [N=50] |
|
| Visit 2: Severe [N=50] |
|
| Visit 3: Remission [N=60] |
|
| Visit 3: Mild [N=60] |
|
| Visit 3: Moderate [N=60] |
|
| Visit 3: Severe [N=60] |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Visit 2: Normal [N=50] |
|
| Visit 2: Suggestive [N=50] |
|
| Visit 2: Case [N=50] |
|
| Visit 3: Normal [N=61] |
|
| Visit 3: Suggestive [N=61] |
|
| Visit 3: Case [N=61] |
|
| Title | Measurements |
|---|---|
|
| Visit 2: Normal [N=50] |
|
| Visit 2: Suggestive [N=50] |
|
| Visit 2: Case [N=50] |
|
| Visit 3: Normal [N=61] |
|
| Visit 3: Suggestive [N=61] |
|
| Visit 3: Case [N=61] |
|