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Evaluation of the Role of Inflammatory and Structural Ultrasound Abnormalities by Explaining the Perspective of Patients With Psoriatic Arthritis

Study Purpose

The perspective of the patient is defined by the patient reported outcomes (PROs). This is a main part of the care in psoriatic arthritis. However , PROs can be influenced by environmental parameters. Ultrasound represents an objective instrument in the context of psoriatic rheumatism (RhPso) care because it measures inflammatory activity and structural damage at joint and periarticular level. it is the first study to evaluate the role of inflammatory and structural ultrasound abnormalities as a cause of modification of the patient's perspective measured by PROs in patients with RhPso.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Patients of both genders above 18 years old.
  • - Capable of adhering to the protocol.
  • - Consent given.
  • - Present one of those disease: - RhPso (confirmed diagnosis) according to The Classification for Psoriatic arthritis criteria (CASPAR) - Rheumatoid arthritis according to ACR/EULAR criteria (American College of Rheumatology/ European League Against Rheumatism) - Digital osteoarthritis according to american college of rheumatology (ACR) criteria.
  • - Cutaneous psoriasis.
  • - Having signed a consent form.
  • - Affiliated to a regimen of health insurance.

Exclusion Criteria:

  • - Patient refusing the study.
  • - The association of two rheumatic diseases (for example: psoriatic arthritis and gout, rheumatoid arthritis and arthritis etc) - The association of another chronic pathology likely to lead to joint manifestations (systemic diseases, bowel chronic inflammatory diseases, overload diseases, .
..)
  • - Patient under trusteeship or protection of vulnerable adults.
- Pregnant or nursing women

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04325724
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Assistance Publique - Hôpitaux de Paris
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Maria-Antonietta D'AGOSTINO, PhD
Principal Investigator Affiliation Rheumatology Department, Ambroise Paré Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Psoriatic Arthritis
Additional Details

It is an interventional study. Patients will be enrolled in the rheumatology department Of Ambroise Paré Hospital in collaboration with the dermatology departments of the hospital. All patients with psoriatic arthritis, beginner or established, or patients with psoriasis suspecting the beginning of rheumatism who will consult or are already followed in those departments and give their approval for the study will undergo.

  • - a clinical rheumatologic assessment (number of painful or swollen joints, enthesitic pain, inflammatory spinal pain) - an ultrasound assessment (peripheral joints, tendon and enthesitic structures and nails).
Those assessment will be made the same day of their consult in one those departments. They will be asked to complete questionnaires (PROs) on the overall assessment of the disease, pain, quality of life, tiredness, physical limitation / disability and the impact of the disease.

Arms & Interventions

Arms

Other: Beginner psoriatic arthritis patients

Every patients consulting in dermatologic or rheumatologic department for a skin psoriasis with clinical symptoms which may lead to the suspicion of psoriatic arthritis

Other: Confirmed psoriatic arthritis patients

Every patients with psoriatic arthritis followed in rheumatologic department

Other: Rheumatoid arthritis or Digital osteoarthritis patients

Followed in rheumatologic department

Other: Skin psoriasis patients without any articular symptoms

Interventions

Other: - General evaluation

Demographic characteristic, psoriasis duration, disease duration, treatments

Other: - Dermatological evaluation

treatment and evaluation

Other: - Rheumatological evaluation

joints, enthesis, tendons, and other ultrasound abnormalities

Other: - para clinical data

biological data, medical imaging data

Other: - Patient reported outcomes (PROs)

Psoriatic arthritis impact of disease 12 (PsAID12), hospital anxiety and depression scale (HAD), SF 36

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Maria-Antonietta D'AGOSTINO, PhD

maria-antonietta.dagostino@aphp.fr

+331 49 09 56 74

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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