Rheumatoid ArthritisDEARNCT02122406
Depression and Anxiety in Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis and Depression, run by University of Pavia at 1 site in Italy.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Depression, Anxiety
- What is being tested?
- Hospital Anxiety and Depression Scale (HADS) questionnaire
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2014to Dec 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with rheumatoid arthritis currently treated with biological drugs.
Who may be able to join
- age >18 years
- diagnosis of rheumatoid arthritis according to 2010 Classification American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) Criteria
- being able to compile questionnaire
- current treatment with biological disease-modifying antirheumatic drug
Who cannot join
- Current treatment for anxiety or depressive disorder
Trial locations and contacts
1 site in 1 country.
Italy1 site
IRCCS policlinico San Matteo - Reparto di Reumatologia
Pavia, PV, 27100
About this study
Official title: Depression and Anxiety in Rheumatoid Arthritis: Prevalence and Relation With Disease Activity
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
Read the detailed description
The prevalence of anxiety and depressive disorders will be assesed with the HADS questionnaire at the time of the visit
- Conditions
- Rheumatoid Arthritis, Depression, Anxiety
- Being tested
- Hospital Anxiety and Depression Scale (HADS) questionnaire
- Keywords
- Rheumatoid Arthritis, Depression, Anxiety, DAS28, HADS
- Medical subject headings
- Arthritis, Rheumatoid, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hospital Anxiety and Depression Scale (HADS) questionnaireOther
Patients filled in the Hospital Anxiety and Depression Scale (HADS) questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Patients RA-BIO | Patients with rheumatoid arthritis treated with biological drugs (infliximab, adalimumab, etanercept, abatacept, tocilizumab, golimumab, certolizumab, rituximab) Receives: Other: Hospital Anxiety and Depression Scale (HADS) questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day of enrollement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2015
- Study completionDec 2015
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 Rheumatoid ArthritisStudies 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
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vittorio Grosso, University of Pavia
- Investigators
- Roberto Caporali, MD, Study director, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02122406
- Sponsor's protocol ID
- 31748\2009 progetto lorhen
- Acronym
- DEAR
- Status last verified
- Aug 2016
- First submitted
- 22 Apr 2014
- Last updated
- 10 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Depression and Anxiety in Rheumatoid Arthritis: Prevalence and Relation With Disease Activity
- ClinicalTrials.gov ID
- NCT02122406
- Acronym / sponsor ID
- DEAR / 31748\2009 progetto lorhen
- Conditions
- Rheumatoid Arthritis, Depression, Anxiety
- Keywords
- Rheumatoid Arthritis, Depression, Anxiety, DAS28, HADS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 24 Apr 2014 (estimated)
- Results
- Posted 10 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
The prevalence of anxiety and depressive disorders will be assesed with the HADS questionnaire at the time of the visit
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients RA-BIO | – | Other: Hospital Anxiety and Depression Scale (HADS) questionnairePatients with rheumatoid arthritis treated with biological drugs (infliximab, adalimumab, etanercept, abatacept, tocilizumab, golimumab, certolizumab, rituximab) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with rheumatoid arthritis currently treated with biological drugs.
Key inclusion criteria (4 listed)
- age >18 years
- diagnosis of rheumatoid arthritis according to 2010 Classification American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) Criteria
- being able to compile questionnaire
- current treatment with biological disease-modifying antirheumatic drug
Key exclusion criteria (1 listed)
- Current treatment for anxiety or depressive disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hospital Anxiety and Depression Scale (HADS) questionnairePatients filled in the Hospital Anxiety and Depression Scale (HADS) questionnaire | Other | Patients RA-BIO |
Primary outcome
Hospital Anxiety and Depression Scale (HADS)
Time frame: 1 day of enrollement
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Roberto Caporali, MD study director
University of Pavia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis and Depression, run by University of Pavia at 1 site in Italy.
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 4 inclusion and 1 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 10 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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 10 Oct 2016). 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?
Hospital Anxiety and Depression Scale (HADS) (time frame: 1 day of enrollement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Oct 2016.