Validation of the PsASon ULtrasound Scores in Patients With Psoriatic Arthritis Undergoing TReatment With Apremilast

Study Purpose

The main purpose of this study is to validate the ultrasound scores PsASon22 and PsASon13 in patients with active psoriatic arthritis undergoing a treatment with Apremilast.

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 - 90 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Male or female patient ≥18 years and <90 years of age 2. PsA according to CASPAR criteria 3. Peripheral manifestation (arthritis, tenosynovitis, dactylitis and/or enthesitis) 4. Active disease as defined by a DAPSA >14 and clinical indication for treatment with Apremilast (as per approved indication for PsA, including failure to methotrexate) 5. Written informed consent

Exclusion Criteria:

1. Inability to perform US at any site included in the PsASon22 or PsASon13 score (f.e. due to complete destruction of a joint) 2. Planned surgery within the study period or history of surgery of any of the joints to be investigated clinically or by sonography. 3. Contraindication to Apremilast (as per patient information leaflet) 4. Current severe medical illness requiring hospitalization 5. Pregnancy or lactation 6. Inability of the patient to follow the treatment protocol 7. Fulfillment of the MDA Criteria or DAPSA≤14 8. Current treatment with any investigational drug 9. Current treatment with glucocorticoids at a prednisone equivalent >10mg 10. Intra-articular glucocorticoid injection in one of the joints to be investigated clinically or by sonography, or intra-muscular glucocorticoid injection within 8 weeks before baseline 11. Change, including dosage changes or discontinuation, of csDMARD treatment (with the exception of leflunomide) in the last 4 weeks before baseline 12. Change, including dosage changes or discontinuation of leflunomide treatment in the last 8 weeks before baseline. (Exception: If patients stop leflunomide and complete an 11 day treatment with cholestyramine (8g, 3 x daily), prior to the baseline visit, they may enter the study.) 13. Current bDMARD, tsDMARD treatment 14. Prior bDMARD or tsDMARD treatment without a minimal washout period before baseline (the minimal washout period is twice the half-life of the respective drug)

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.

NCT04102449
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.

Phase 4
Lead Sponsor

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

Medical University of Graz
Principal Investigator

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

Rusmir Husic, Dr.
Principal Investigator Affiliation Medical University of Graz
Agency Class

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

OtherIndustryOtherOther
Overall Status Not yet recruiting
Countries
Conditions

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

Psoriatic Arthritis
Additional Details

This is a prospective, multicentre, phase IV trial assessing the value of the ultrasound scores PsASon22 and PsASon13 in differentiating between clinically active and inactive patients with psoriatic arthritis, following a treatment with Apremilast for up to 24 months. Additionally, convergent construct validity, inter/intra-reader reliability, sensitivity to change and differences in change in certain patients will be tested for the ultrasound scores.

Arms & Interventions

Arms

Other: Treatment with Apremilast

Single group: Apremilast will be prescribed according to the patient information leaflet, i.e.: Dosage form: Oral pill Dosage and Frequency: First 6 days titration phase, followed by 30mg twice daily (in case of kidney problems 30mg once daily in the morning). Treatment duration at the discretion of the treating physician.

Interventions

Drug: - Apremilast

Single arm receiving Apremilast and ultrasound examinations

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:

Rusmir Husic, Dr.

[email protected]

0043316385

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

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.