A Clinical Study of Sub-clinical Enthesitis in Patients With Psoriasis and Healthy Controls

Study Purpose

A clinical study of subclinical enthesitis in patients with psoriasis and healthy controls

Recruitment Criteria

Accepts Healthy Volunteers

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

Yes
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.

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

Inclusion Criteria:

  • - Age≥18years - Patients with psoriasis without musculoskeletal symptoms - Healthy controls - No joint involvement and no clinical symptoms and signs of enthesitis and synovitis

    Exclusion Criteria:

    - Have history of gout or arthritis or peripheral neurological disease of lower extremity.
  • - Have history of trauma and intensive sport activity in last 2 weeks.
- Have received any systemic therapy (i.e. DMARD, NSAIDs, corticosteroids, immunosuppressants, retinoids or biological agents) in 3 months - Pregnant or breast-feeding

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.

NCT04209894
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.

Lead Sponsor

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

Fatih Sultan Mehmet Training and Research Hospital
Principal Investigator

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

Duygu Silte Karamanlioglu, MDFeyza Unlu Ozkan, Assoc. Prof.Eylem Ceren Arikan, MDGulcan Ozturk, MDİlknur Aktas, Prof.
Principal Investigator Affiliation Fatih Sultan Mehmet Training and Research HospitalFatih Sultan Mehmet Training and Research HospitalFatih Sultan Mehmet Training and Research HospitalFatih Sultan Mehmet Training and Research HospitalFatih Sultan Mehmet Training and Research Hospital
Agency Class

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

Other
Overall Status Not yet recruiting
Countries Turkey
Conditions

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

Enthesitis
Additional Details

A total of 30 patients with psoriasis and 30 age-matched healthy controls, all without musculoskeletal diseases, will be recruited. They will undergo dermatological assessment and a blinded ultrasound (US) evaluation. Clinical assessment included demographics, severity of psoriasis and musculoskeletal clinical examination. Evaluation consisted of the detection of grey scale (GS) enthesitis and Power Doppler signal in enthesis areas. The Madrid Sonography Enthesitis Index (MASEI) scoring system was used to quantify the extent of sonographic entheseal abnormalities.

Arms & Interventions

Arms

: Psoriasis

They will undergo dermatological assessment and a blinded ultrasound (US) evaluation.

: Control

They will also undergo dermatological assessment and a blinded ultrasound (US) evaluation.

Interventions

Diagnostic Test: - Ultrasound

Evaluation consisted of the detection of grey scale (GS) enthesitis and Power Doppler signal in enthesis areas of participants. The Madrid Sonography Enthesitis Index (MASEI) scoring system was used to quantify the extent of sonographic entheseal abnormalities

Contact a Trial Team

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International Sites

Istanbul, Atasehir, Turkey

Status

Address

Fatih Sultan Mehmet Training and Research Hospital

Istanbul, Atasehir, 34758

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