Centre Hospitalier d'Avignon
Avignon, France
NCT Number: NCT06101706
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Avignon, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
FACIT-F questionnaire and Visual Analog Scale for fatigue
PsAID-12 questionnaire, DLQI questionnaire and SF-36 questionnaire
DAPSA score
PASI score
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).
Time frame: Baseline
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
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
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
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
Disease Activity in Psoriatic Arthritis : DAPSA (this score range from 0 to 164, a high score represents a more severe disease).
Time frame: Baseline
Psoriasis Area Severity Index : PASI (this score range from 0 to 72, a high score represents a more severe disease).
Centre Hospitalier Henri Duffaut - Avignon
Other
Acronym: RPso-Fatigue
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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