Psoriatic ArthritisRPso-FatigueNCT06101706
Assessment of Fatigue in Psoriatic Arthritis and Cutaneous Psoriasis Patients
A study testing Fatigue assessment, Quality of life assessment and Assess severity of psoriatic arthritis in people with Psoriatic Arthritis and Psoriasis, run by Centre Hospitalier Henri Duffaut - Avignon at 1 site in France.
Trial summary
Psoriatic arthritis is characterized with pain, swelling and joint stiffness. These are inflammatory reactions against tendons, ligaments and joints associated with fatigue. In France, almost 93.000 people are affected by psoriatic arthritis and the main symptoms appear between 30 and 50 years old. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriatic Arthritis, Psoriasis
- What is being tested?
- Fatigue assessment, Quality of life assessment and Assess severity of psoriatic arthritis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- 11 Mar 2024to 2 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Patient over 18 years old.
- Patient with psoriatic arthritis of any stage or duration, followed in the center's rheumatology or dermatology departments, whether or not treated with systemic therapy.
- Patient with all forms of cuteaneous psoriasis (plaque, inverted, erythrodermic or guttate), whatever the stage or duration of the disease, followed in the center's dermatology department, whether or not treated with systemic therapy.
Who cannot join
- Patient with auto-inflammatory joint disease: ankylosing spondylitis, rheumatoid arthritis.
- Patient with auto-immune disease involving skin lesions: lupus, dermatomyositis, morphea, pemphigus, pemphigoid, Sjögren's syndrome.
- Cancer.
- Pregnant women.
- Severe heart failure (New York Heart Association Class III or IV).
- Severe renal failure (DFG < 30).
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- Hepatic failure.
- Anemia < 10g/dL.
- Patient under legal protection, deprived of liberty or unable to be included in a research protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Psoriatic arthritis is characterized with pain, swelling and joint stiffness. These are inflammatory reactions against tendons, ligaments and joints associated with fatigue. In France, almost 93.000 people are affected by psoriatic arthritis and the main symptoms appear between 30 and 50 years old. Psoriatic arthritis may be due to a genetic predisposition involving the HLA B27 gene, or to environmental factors such as stress, physical or psychological trauma, or infection. Obesity, type 2 diabetes and hypertension can also be factors associated with the onset of psoriatic arthritis.
Cutaneous psoriasis is a non-contagious chronic inflammatory skin disease, where the skin renews itself at an abnormally rapid rate. In France, between 2 and 3 million people are affected by cutaneous psoriasis, approximately 60.000 new cases every year. The disease begin in adolescence or young adulthood. There are multiples forms of cutaneous psoriasis (plaque, guttate, pustular, erythrodermic, inverse, facial, scalp, nail and mucous membranes). The main symptom is the appearance of thick red patches of varying size, covered with white dead skin. These lesions are most often found on the hands, elbows, knees, lower back, face or scalp. There is little to no itching. During periods of remission, lesions can disappear completely or partially, then reappear during a new attack, called a "flare-up". A familial genetic predisposition is present in 1/3 of psoriasis patients. Other immune and environmental factors, such as medication, irritations, sun exposure or psychological state, can influence psoriasis flare-ups. Psoriasis has no serious health consequences, but it can be aesthetically unpleasant, affect relationships and psychological well-being.
Read more
Fatigue is a common symptom in psoriatic arthritis patients, and can significantly affect quality of life and work capacity. Fatigue, which affects over 50% of psoriatic arthritis patients, is a major component of the disease's impact. Fatigue in psoriatic arthritis is a much-discussed topic in the current scientific literature. Although less well documented, patients with cutaneous psoriasis also experience fatigue. Several clinical trials show that, once the disease has been treated, fatigue tends to diminish, but in some cases, the treatment itself may play a role in the vicious fatigue circle. The risk of suffering other skin manifestations despite being under treatment can often be misunderstood by the patient, leading to increased depression and fatigue. Overall, treatments are more likely to play an important role in the variability of fatigue. Ultimately, fatigue is a multifactorial symptom that can be linked either to the disease itself, or to the therapies used. It therefore appears to be the most difficult symptom to treat with commercially available therapies.
As fatigue is a major symptom of psoriatic arthritis and cutaneous psoriasis, it is essential to know how the therapies offered influence this symptom, and to study whether certain therapies are more likely to increase it, despite their efficacy on joint and skin symptoms. It is also relevant to determine whether fatigue is correlated with disease severity, duration and even more so with the therapy used, to better understand the psychological impact of patients with psoriatic arthritis or cutaneous psoriasis.
- Conditions
- Psoriatic Arthritis, Psoriasis
- Being tested
- Fatigue assessment, Quality of life assessment, Assess severity of psoriatic arthritis, Assess severity of cutaneous psoriasis
- Keywords
- Fatigue, Quality of life
- Medical subject headings
- Arthritis, Psoriatic, Psoriasis, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fatigue assessmentBehavioural
FACIT-F questionnaire and Visual Analog Scale for fatigue
Quality of life assessmentBehavioural
PsAID-12 questionnaire, DLQI questionnaire and SF-36 questionnaire
Assess severity of psoriatic arthritisOther
DAPSA score
Assess severity of cutaneous psoriasisOther
PASI score
| Study group | Role | What they receive |
|---|---|---|
| Psoriatic arthritis patients | Other | Not described Receives: Behavioral: Fatigue assessment; Behavioral: Quality of life assessment; Other: Assess severity of psoriatic arthritis |
| Cutaneous psoriasis patients | Other | Not described Receives: Behavioral: Fatigue assessment; Behavioral: Quality of life assessment; Other: Assess severity of cutaneous psoriasis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare fatigue between psoriatic arthritis and cutaneous psoriasis patients
Functional Assessment of Chronic Illness Therapy System of Quality of Life questionnaire : FACIT-F (this questionnaire contains 13 items, each item score can range from 0 to 5, the total score range from 0 to 52, a high score represents a high quality of life).
Measured: Baseline
Secondary outcomes (6)
Assess and compare fatigue score by disease, treatment type and demographic data
Fatigue will be assessed by Visual Analog Scale (a subjective measure for fatigue, scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no fatigue" and "maximum fatigue imaginable").
Measured: Baseline
Assess and compare quality of life
Psoriatic Arthritis Impact of Disease : PsAID-12 (this questionnaire contains 12 items, the total score range from 0 to 10, a high score represents the worst health condition).
Measured: Baseline
Assess and compare quality of life
Dermatology Life Quality Index : DLQI (this questionnaire contains 10 items, the total score range from 0 to 30, a high score represents a low quality of life).
Measured: Baseline
Assess and compare quality of life
36-Item Short Form Survey : SF-36 (this questionnaire contains 36 items, the total score range from 0 to 100, a high score represents a high quality of life).
Measured: Baseline
Assess severity of psoriatic arthritis
Disease Activity in Psoriatic Arthritis : DAPSA (this score range from 0 to 164, a high score represents a more severe disease).
Measured: Baseline
Assess severity of cutaneous psoriasis
Psoriasis Area Severity Index : PASI (this score range from 0 to 72, a high score represents a more severe disease).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start11 Mar 2024
- Primary completion2 May 2025
- Study completion2 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriatic 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Henri Duffaut - Avignon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carina Mihu, Medical Intern, Principal investigator, Centre Hospitalier d'Avignon, Service de dermatologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06101706
- Sponsor's protocol ID
- RPso-Fatigue
- Acronym
- RPso-Fatigue
- Status last verified
- Jan 2026
- First submitted
- 16 Oct 2023
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Fatigue in Psoriatic Arthritis and Cutaneous Psoriasis Patients
- ClinicalTrials.gov ID
- NCT06101706
- Acronym / sponsor ID
- RPso-Fatigue / RPso-Fatigue
- Conditions
- Psoriatic Arthritis, Psoriasis
- Keywords
- Fatigue, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Centre Hospitalier Henri Duffaut - AvignonUniversity, hospital or other
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- 2 May 2025 (actual)
- Study completion
- 2 Sep 2025 (actual)
- First posted
- 26 Oct 2023 (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.
Psoriatic arthritis is characterized with pain, swelling and joint stiffness. These are inflammatory reactions against tendons, ligaments and joints associated with fatigue. In France, almost 93.000 people are affected by psoriatic arthritis and the main symptoms appear between 30 and 50 years old. Psoriatic arthritis may be due to a genetic predisposition involving the HLA B27 gene, or to environmental factors such as stress, physical or psychological trauma, or infection. Obesity, type 2 diabetes and hypertension can also be factors associated with the onset of psoriatic arthritis.
Cutaneous psoriasis is a non-contagious chronic inflammatory skin disease, where the skin renews itself at an abnormally rapid rate. In France, between 2 and 3 million people are affected by cutaneous psoriasis, approximately 60.000 new cases every year. The disease begin in adolescence or young adulthood. There are multiples forms of cutaneous psoriasis (plaque, guttate, pustular, erythrodermic, inverse, facial, scalp, nail and mucous membranes). The main symptom is the appearance of thick red patches of varying size, covered with white dead skin. These lesions are most often found on the hands, elbows, knees, lower back, face or scalp. There is little to no itching. During periods of remission, lesions can disappear completely or partially, then reappear during a new attack, called a "flare-up". A familial genetic predisposition is present in 1/3 of psoriasis patients. Other immune and environmental factors, such as medication, irritations, sun exposure or psychological state, can influence psoriasis flare-ups. Psoriasis has no serious health consequences, but it can be aesthetically unpleasant, affect relationships and psychological well-being.
Fatigue is a common symptom in psoriatic arthritis patients, and can significantly affect quality of life and work capacity. Fatigue, which affects over 50% of psoriatic arthritis patients, is a major component of the disease's impact. Fatigue in psoriatic arthritis is a much-discussed topic in the current scientific literature. Although less well documented, patients with cutaneous psoriasis also experience fatigue. Several clinical trials show that, once the disease has been treated, fatigue tends to diminish, but in some cases, the treatment itself may play a role in the vicious fatigue circle. The risk of suffering other skin manifestations despite being under treatment can often be misunderstood by the patient, leading to increased depression and fatigue. Overall, treatments are more likely to play an important role in the variability of fatigue. Ultimately, fatigue is a multifactorial symptom that can be linked either to the disease itself, or to the therapies used. It therefore appears to be the most difficult symptom to treat with commercially available therapies.
As fatigue is a major symptom of psoriatic arthritis and cutaneous psoriasis, it is essential to know how the therapies offered influence this symptom, and to study whether certain therapies are more likely to increase it, despite their efficacy on joint and skin symptoms. It is also relevant to determine whether fatigue is correlated with disease severity, duration and even more so with the therapy used, to better understand the psychological impact of patients with psoriatic arthritis or cutaneous psoriasis.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psoriatic arthritis patients | Other | Behavioral: Fatigue assessment, Behavioral: Quality of life assessment, Other: Assess severity of psoriatic arthritis |
| Cutaneous psoriasis patients | Other | Behavioral: Fatigue assessment, Behavioral: Quality of life assessment, Other: Assess severity of cutaneous psoriasis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient over 18 years old.
- Patient with psoriatic arthritis of any stage or duration, followed in the center's rheumatology or dermatology departments, whether or not treated with systemic therapy.
- Patient with all forms of cuteaneous psoriasis (plaque, inverted, erythrodermic or guttate), whatever the stage or duration of the disease, followed in the center's dermatology department, whether or not treated with systemic therapy.
Key exclusion criteria (9 listed)
- Patient with auto-inflammatory joint disease: ankylosing spondylitis, rheumatoid arthritis.
- Patient with auto-immune disease involving skin lesions: lupus, dermatomyositis, morphea, pemphigus, pemphigoid, Sjögren's syndrome.
- Cancer.
- Pregnant women.
- Severe heart failure (New York Heart Association Class III or IV).
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 |
|---|---|---|
| Fatigue assessmentFACIT-F questionnaire and Visual Analog Scale for fatigue | Behavioural | Cutaneous psoriasis patients, Psoriatic arthritis patients |
| Quality of life assessmentPsAID-12 questionnaire, DLQI questionnaire and SF-36 questionnaire | Behavioural | Cutaneous psoriasis patients, Psoriatic arthritis patients |
| Assess severity of psoriatic arthritisDAPSA score | Other | Psoriatic arthritis patients |
| Assess severity of cutaneous psoriasisPASI score | Other | Cutaneous psoriasis patients |
Primary outcome
Compare fatigue between psoriatic arthritis and cutaneous psoriasis patients
Time frame: Baseline
Functional Assessment of Chronic Illness Therapy System of Quality of Life questionnaire : FACIT-F (this questionnaire contains 13 items, each item score can range from 0 to 5, the total score range from 0 to 52, a high score represents a high quality of life).
6 secondary outcomes
Assess and compare fatigue score by disease, treatment type and demographic data
Time frame: Baseline
Assess and compare quality of life
Time frame: Baseline
Assess and compare quality of life
Time frame: Baseline
Assess and compare quality of life
Time frame: Baseline
Assess severity of psoriatic arthritis
Time frame: Baseline
Assess severity of cutaneous psoriasis
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
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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.
Carina Mihu, Medical Intern principal investigator
Centre Hospitalier d'Avignon, Service de dermatologie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fatigue assessment, Quality of life assessment and Assess severity of psoriatic arthritis in people with Psoriatic Arthritis and Psoriasis, run by Centre Hospitalier Henri Duffaut - Avignon 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 3 inclusion and 9 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 9 Jan 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Compare fatigue between psoriatic arthritis and cutaneous psoriasis patients (time frame: Baseline). 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 Jan 2026; AzTrials last refreshed its copy on 8 Nov 2026.