Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Validation of the PsASon ULtrasound Scores in Patients With Psoriatic Arthritis Undergoing TReatment With Apremilast (PSA-ULTRA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04102449
Recruitment Status : Recruiting
First Posted : September 25, 2019
Last Update Posted : September 2, 2020
Sponsor:
Collaborators:
Celgene Corporation
Medical University of Vienna
Medical University Innsbruck
Information provided by (Responsible Party):
Medical University of Graz

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Psoriatic Arthritis Drug: Apremilast Phase 4

Detailed Description:
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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Validation of the PsASon ULtrasound Scores in Patients With Psoriatic Arthritis Undergoing TReatment With Apremilast
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : February 2022


Arm Intervention/treatment
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.

Drug: Apremilast
Single arm receiving Apremilast and ultrasound examinations




Primary Outcome Measures :
  1. The difference in the change-score of the PsASon22 [ Time Frame: 4-12-24 months ]

    The main outcome is the difference in the change-score of the PsASon22 between patients achieving low disease activity or remission (DAPSA≤14) and patients not achieving this target under a treatment with Apremilast.

    The Psoratic Arthritis Sonography Score 22, PsASon22 (range 0-260), is a sum score, including grey scale and power doppler measurements of 22 joints (6 MCPs, 4-H-PIPs, 2 MTPs, 4 H-DIPs, 2 F-DIPs, 4 large joints) and 4 entheses (lateral epicondyle and distal patella - bilateral), with a higher score presumably indicating higher disease activity.


  2. The difference in the change-score of the PsASon13 [ Time Frame: 4-12-24 months ]

    The main outcome is the difference in the change-score of the PsASon13 between patients achieving low disease activity or remission (DAPSA≤14) and patients not achieving this target under a treatment with Apremilast.

    The Psoratic Arthritis Sonography Score 13, PsASon13 (range 0-134), is a sum score, including grey scale and power doppler measurements of 13 joints (2 MCPs, 3-H-PIPs, 1-F-PIP, 2 MTPs, 1 H-DIPs, 2 F-DIPs, 2 large joints) and 2 entheses (lateral epicondyle and distal patella - unilateral), with a higher score presumably indicating higher disease activity.



Secondary Outcome Measures :
  1. Convergent construct validity of PsAson22 and PsASon13 [ Time Frame: 4-12-24 months ]
    Convergent construct validity will be assessed by correlating the ultrasound scores to clinical composite scores (f.e. DAPSA)

  2. Sensitivity to Change of PsASon22 and PsASon13 [ Time Frame: 4-12-24 months ]
    Sensitivity to change will be assessed by measuring the PsASon22 and PsASon 13 scores at four different time points (Baseline and after 4, 12 and 24 months)

  3. Interrater reliability of PsASon22 and PsASon13 [ Time Frame: 4-12-24 months ]
    Interrater reliability will be assessed by performing multiple ultrasound examinations for one patient by multiple examinators

  4. Intrarater reliability of PsASon22 and PsASon13 [ Time Frame: 4-12-24 months ]
    Intrarater reliability will be assessed by performing multiple ultrasound examinations for one patient by multiple examinators

  5. Differences in PsASon22 and PsASon13 change [ Time Frame: 4-12-24 months ]
    Differences in change will be assessed by comparing the change scores of patients with initially high disease activity (DAPSA>28) with the change scores of patients with initially moderate disease activity (DAPSA>14-≤28)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04102449


Contacts
Layout table for location contacts
Contact: Rusmir Husic, Dr. 0043316385 ext 17779 rusmir.husic@medunigraz.at

Locations
Layout table for location information
Austria
Medical University of Graz Recruiting
Graz, Styria, Austria, 8010
Contact: Rusmir Husic, MD       rusmir.husic@medunigraz.at   
Sponsors and Collaborators
Medical University of Graz
Celgene Corporation
Medical University of Vienna
Medical University Innsbruck
Investigators
Layout table for investigator information
Principal Investigator: Rusmir Husic, Dr. Medical University of Graz
Layout table for additonal information
Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT04102449    
Other Study ID Numbers: AP-CL-PSA-PI-12856
First Posted: September 25, 2019    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: September 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Medical University of Graz:
Ultrasound
Psoriatic arthritis
Outcome measures
Apremilast
Disease activity
Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Apremilast
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents