Rheumatic DiseasesEMOTIONNCT04817072
Evaluation of Mood Disorders Under Biologics in Chronic Inflammatory Rheumatic Disease
A study testing Blood sample in people with Rheumatic Diseases and Mood Disorders, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
Chronic inflammatory rheumatic diseases (CIRD) affect many organ systems. Painful sensations within the joints spine, hand and foot deformities, low quality of life and psychosocial status in patients with rheumatoid arthritis, spondyloarthritis and psoriatic arthritis can lead to the development of anxiety and… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rheumatic Diseases, Mood Disorders
- What is being tested?
- Blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteFrance
- Study dates
- 19 May 2021to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (≥18 ; ≤ 80)
- Patient with rheumatoid arthritis (RA) according to the ACR 2010 criteria, axial or peripheral spondyloarthritis (SpA) according to ASAS criteria, ankylosing spondylitis (AS) according to the New York criteria or psoriatic arthritis (PsA) according to CASPAR criteria
- Signature of informed consent
- Affiliation to a French social security or receiving such a scheme
Who cannot join
- Patient having previously received anti-TNFα treatment
- Patient with previously diagnosed depressive or psychiatric pathology and / or receiving anti-depressant treatment
- Subjects with limited legal capacity.
- Subjects judged by the investigator to be unlikely to comply with study procedures
- Subjects with no social security coverage.
- Pregnant women.
- Subjects still in the exclusion period of another study, or according to the national registry of clinical trial participants.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Magali Nicolier-Pallandre, PhD contact
France1 site, 1 recruiting
- Recruiting
University Hospital
Besançon, 25000
Charline VAUCHY
Eric Toussirot, PU-PH
About this study
Official title: Evaluation of Mood Disorders Under Biologics (Anti-TNF Alpha) in Chronic Inflammatory Rheumatic Disease
Chronic inflammatory rheumatic diseases (CIRD) affect many organ systems. Painful sensations within the joints spine, hand and foot deformities, low quality of life and psychosocial status in patients with rheumatoid arthritis, spondyloarthritis and psoriatic arthritis can lead to the development of anxiety and depression. Prevalences of anxiety increase in patients suffering of CIRD, compared with healthy individuals. Another connection has been identified by the links between depression and systemic inflammation. It is proven that higher plasma levels of pro-inflammatory cytokines such as tumor necrosis factor alpha (TNFa) affect neurotransmitter metabolism, with influence on patients mood. The purpose of EMOTION study is therefore to analyze thymic variation under TNFa therapy, as treatment of CIRDs.
- Conditions
- Rheumatic Diseases, Mood Disorders
- Being tested
- Blood sample
- Keywords
- TNF alpha inhibitor
- Medical subject headings
- Rheumatic Diseases, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
Blood sample (20mL) for pro-inflammatory cytokines assay
| Study group | Role | What they receive |
|---|---|---|
| Chronic inflammatory rheumatic disease | Other | Patients presenting a chronic inflammatory rheumatic disease (rheumatoid arthritis, spondyloarthritis or psoriatic arthritis), requiring anti-TNFa therapy and with a QIDS SR-16 (QIDS-SR 16-Quick Inventory of Depressive Symptomatology-Self Reported 16 items) score between 6 and 19 Receives: Other: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of depressive symptoms
Score achieved on the validated self-report questionnaire (QIDS SR16) evaluating the severity of depressive symptoms
Measured: 1 month after initiation of anti-TNFa therapy
Secondary outcomes (6)
Evaluation of disease activity
Evaluation with CPDAI (Composite Psoriatic Disease Activity Index) (minimum value: 0; maximum value: 15; increases with the activity of the disease)
Measured: 3 months after initiation of anti-TNFa therapy
Evaluation of disease activity
Evaluation with DAS28 (Disease Activity Score 28-joint count) (minimum value: 0; maximum value: 9.4; increases with the activity of the disease)
Measured: 3 months after initiation of anti-TNFa therapy
Evaluation of disease activity
Evaluation with BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) (minimum value: 0 (no disease activity); maximum value: 10 (very active disease))
Measured: 3 months after initiation of anti-TNFa therapy
Evaluation of disease activity
Evaluation with ASDAS (Ankylosing Spondylitis Disease Activity Score) (minimum value: 0 (no disease activity); value >3.5 between : very high disease activity)
Measured: 3 months after initiation of anti-TNFa therapy
Evaluation of Fatigue
Evaluation with Functional Assessment of Chronic Illness Therapy
Measured: 3 months after initiation of anti-TNFa therapy
Evaluation of Pleasure
Evaluation with Snaith-Hamilton pleasure scale (minimum value: 0 (no disease activity); maximum value: 14 (very active disease)). A higher total SHAPS score indicated higher levels of anhedonia.
Measured: 3 months after initiation of anti-TNFa therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start19 May 2021
- Primary completionNov 2025 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatic DiseasesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Toussirot, PU-PH, Principal investigator, Besançon University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04817072
- Sponsor's protocol ID
- P/2019/462
- Acronym
- EMOTION
- Status last verified
- Nov 2024
- First submitted
- 29 Jan 2021
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Mood Disorders Under Biologics (Anti-TNF Alpha) in Chronic Inflammatory Rheumatic Disease
- ClinicalTrials.gov ID
- NCT04817072
- Acronym / sponsor ID
- EMOTION / P/2019/462
- Conditions
- Rheumatic Diseases, Mood Disorders
- Keywords
- TNF alpha inhibitor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 19 May 2021 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 25 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic inflammatory rheumatic diseases (CIRD) affect many organ systems. Painful sensations within the joints spine, hand and foot deformities, low quality of life and psychosocial status in patients with rheumatoid arthritis, spondyloarthritis and psoriatic arthritis can lead to the development of anxiety and depression. Prevalences of anxiety increase in patients suffering of CIRD, compared with healthy individuals. Another connection has been identified by the links between depression and systemic inflammation. It is proven that higher plasma levels of pro-inflammatory cytokines such as tumor necrosis factor alpha (TNFa) affect neurotransmitter metabolism, with influence on patients mood. The purpose of EMOTION study is therefore to analyze thymic variation under TNFa therapy, as treatment of CIRDs.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic inflammatory rheumatic disease | Other | Other: Blood samplePatients presenting a chronic inflammatory rheumatic disease (rheumatoid arthritis, spondyloarthritis or psoriatic arthritis), requiring anti-TNFa therapy and with a QIDS SR-16 (QIDS-SR 16-Quick Inventory of Depressive Symptomatology-Self Reported 16 items) score between 6 and 19 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients (≥18 ; ≤ 80)
- Patient with rheumatoid arthritis (RA) according to the ACR 2010 criteria, axial or peripheral spondyloarthritis (SpA) according to ASAS criteria, ankylosing spondylitis (AS) according to the New York criteria or psoriatic arthritis (PsA) according to CASPAR criteria
- Signature of informed consent
- Affiliation to a French social security or receiving such a scheme
Key exclusion criteria (7 listed)
- Patient having previously received anti-TNFα treatment
- Patient with previously diagnosed depressive or psychiatric pathology and / or receiving anti-depressant treatment
- Subjects with limited legal capacity.
- Subjects judged by the investigator to be unlikely to comply with study procedures
- Subjects with no social security coverage.
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 |
|---|---|---|
| Blood sampleBlood sample (20mL) for pro-inflammatory cytokines assay | Other | Chronic inflammatory rheumatic disease |
Primary outcome
Severity of depressive symptoms
Time frame: 1 month after initiation of anti-TNFa therapy
Score achieved on the validated self-report questionnaire (QIDS SR16) evaluating the severity of depressive symptoms
6 secondary outcomes
Evaluation of disease activity
Time frame: 3 months after initiation of anti-TNFa therapy
Evaluation of disease activity
Time frame: 3 months after initiation of anti-TNFa therapy
Evaluation of disease activity
Time frame: 3 months after initiation of anti-TNFa therapy
Evaluation of disease activity
Time frame: 3 months after initiation of anti-TNFa therapy
Evaluation of Fatigue
Time frame: 3 months after initiation of anti-TNFa therapy
Evaluation of Pleasure
Time frame: 3 months after initiation of anti-TNFa therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Rheumatic Diseases
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
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.
Magali Nicolier-Pallandre, PhD contact
Eric Toussirot, PU-PH principal investigator
Besançon University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample in people with Rheumatic Diseases and Mood Disorders, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
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 7 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: looking for participants now, as of the sponsor's last update on 9 Jul 2025. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charline Vauchy, PhD (+333 81 21 88 75, cvauchy@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of depressive symptoms (time frame: 1 month after initiation of anti-TNFa therapy). 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 9 Jul 2025.