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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

Tracking Information
First Submitted Date  ICMJE September 23, 2019
First Posted Date  ICMJE September 25, 2019
Last Update Posted Date September 2, 2020
Actual Study Start Date  ICMJE July 1, 2020
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 1, 2019)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 23, 2019)
The difference in the change-scores of the PsASon22 and PsASon13 [ Time Frame: 4-12-24 months ]
The main outcome is the difference in the change-scores of the PsASon22 and PsASon13 between patients achieving a level of remission (DAPSA≤14) and patients not achieving a level of remission under a treatment with Apremilast.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2019)
  • 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)
  • 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)
  • 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
  • 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
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Validation of the PsASon ULtrasound Scores in Patients With Psoriatic Arthritis Undergoing TReatment With Apremilast
Official Title  ICMJE Validation of the PsASon ULtrasound Scores in Patients With Psoriatic Arthritis Undergoing TReatment With Apremilast
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Psoriatic Arthritis
Intervention  ICMJE Drug: Apremilast
Single arm receiving Apremilast and ultrasound examinations
Study Arms  ICMJE 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.

Intervention: Drug: Apremilast
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 23, 2019)
62
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2022
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Rusmir Husic, Dr. 0043316385 ext 17779 rusmir.husic@medunigraz.at
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04102449
Other Study ID Numbers  ICMJE AP-CL-PSA-PI-12856
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medical University of Graz
Study Sponsor  ICMJE Medical University of Graz
Collaborators  ICMJE
  • Celgene Corporation
  • Medical University of Vienna
  • Medical University Innsbruck
Investigators  ICMJE
Principal Investigator: Rusmir Husic, Dr. Medical University of Graz
PRS Account Medical University of Graz
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP