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CompletedNCT06101706RPso-FatigueUpdated Jan 9, 2026

Assessment of Fatigue in Psoriatic Arthritis and Cutaneous Psoriasis Patients

An interventional study of Fatigue assessment and Quality of life assessment in Psoriatic Arthritis and Psoriasis, sponsored by Centre Hospitalier Henri Duffaut - Avignon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-09.

Sponsored by Centre Hospitalier Henri Duffaut - Avignon · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
33
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Psoriatic Arthritis
  • Psoriasis

Keywords

  • Fatigue
  • Quality of life
03

In context

Arthritis, Psoriatic

600 studies on the registry are indexed under Arthritis, Psoriatic; 129 are open to participants now.

This study's enrollment of 33 is below the median of 145 across 336 interventional studies indexed under Arthritis, Psoriatic.

Browse Arthritis, Psoriatic studies →

Lead sponsor

Centre Hospitalier Henri Duffaut - Avignon is the lead sponsor of 10 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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 ( Class III or IV).
  • Severe renal failure (DFG \< 30).
  • Hepatic failure.
  • Anemia \< 10g/dL.
  • Patient under legal protection, deprived of liberty or unable to be included in a research protocol.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
33 participants (actual)

Study arms

  • Other
    Psoriatic arthritis patients

    Behavioral: Fatigue assessment · Behavioral: Quality of life assessment · Other: Assess severity of psoriatic arthritis

  • Other
    Cutaneous psoriasis patients

    Behavioral: Fatigue assessment · Behavioral: Quality of life assessment · Other: Assess severity of cutaneous psoriasis

Interventions

  • BehavioralFatigue assessment

    FACIT-F questionnaire and Visual Analog Scale for fatigue

  • BehavioralQuality of life assessment

    PsAID-12 questionnaire, DLQI questionnaire and SF-36 questionnaire

  • OtherAssess severity of psoriatic arthritis

    DAPSA score

  • OtherAssess severity of cutaneous psoriasis

    PASI score

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Baseline

Secondary outcomes

  1. 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").

    Time frame: Baseline

  2. 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).

    Time frame: Baseline

  3. 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).

    Time frame: Baseline

  4. 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).

    Time frame: Baseline

  5. 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).

    Time frame: Baseline

  6. 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).

    Time frame: Baseline

07

Study locations

1 site
  • Centre Hospitalier d'Avignon
    Avignon, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06101706
Lead sponsor
Centre Hospitalier Henri Duffaut - Avignon
Responsible party
Sponsor
First posted
Oct 26, 2023
Start date
Mar 11, 2024
Primary completion
May 2, 2025
Completion
Sep 2, 2025
Last update
Jan 9, 2026

Study contacts

Carina Mihu, Medical Intern
principal investigator · Centre Hospitalier d'Avignon, Service de dermatologie

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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