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The primary endpoint of this study is to evaluate the prevalence of anxiety and depressive disorders, and their relationship with disease activity, in patients with rheumatoid arthritis treated with biological drugs
The prevalence of anxiety and depressive disorders will be assesed with the HADS questionnaire at the time of the visit
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients RA-BIO | Patients with rheumatoid arthritis treated with biological drugs (infliximab, adalimumab, etanercept, abatacept, tocilizumab, golimumab, certolizumab, rituximab) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hospital Anxiety and Depression Scale (HADS) questionnaire | Other | Patients filled in the Hospital Anxiety and Depression Scale (HADS) questionnaire |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Anxiety and Depression Scale (HADS) | Hospital Anxiety and Depression Scale (HADS) questionnaire. The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains. Patients were defined as having anxiety or depression or both if the score was 8 or more in the corresponding subscale. | 1 day of enrollement |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with rheumatoid arthritis currently treated with biological drugs.
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| Name | Affiliation | Role |
|---|---|---|
| Roberto Caporali, MD | University of Pavia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS policlinico San Matteo - Reparto di Reumatologia | Pavia | PV | 27100 | Italy |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients RA-BIO | Patients with rheumatoid arthritis treated with biological drugs |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients RA-BIO | Patients with rheumatoid arthritis treated with biological drugs |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Hospital Anxiety and Depression Scale (HADS) | Hospital Anxiety and Depression Scale (HADS) questionnaire. The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains. Patients were defined as having anxiety or depression or both if the score was 8 or more in the corresponding subscale. | Posted | Number | participants | 1 day of enrollement |
|
|
at the time of the visit
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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 | Patients RA-BIO | Patients with rheumatoid arthritis treated with biological drugs |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vittorio Grosso MD | University of Pavia | +393332605945 | vittorio.grosso@gmail.com |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C018209 | 4-amino-4'-hydroxylaminodiphenylsulfone |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Disease Duration | Median | Inter-Quartile Range | years |
|
| Disease Activity Score on 28 joints (DAS28) | The Disease Activity Score 28 (DAS28) is a combined index that measures the disease activity in patients with Rheumatoid Arthritis. It is based on the assessment of the number of swollen and tender joints and measure of the ESR. Lower values indicate lower disease activity levels. It ranges from 0.49 to 9.35. | Mean | Standard Deviation | units on a scale |
|
| Participants |
|
|
| 0 |
| 200 |
| 0 |
| 200 |
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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |