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

Primary Purpose

Psoriatic Arthritis

Status
Withdrawn
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
Apremilast
Sponsored by
Medical University of Graz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Psoriatic Arthritis focused on measuring Ultrasound, Psoriatic arthritis, Outcome measures, Apremilast, Disease activity

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Medical University of Graz

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Treatment with Apremilast

Arm Description

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.

Outcomes

Primary Outcome Measures

The difference in the change-score of the PsASon22
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
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

Convergent construct validity of PsAson22 and PsASon13
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
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
Interrater reliability will be assessed by performing multiple ultrasound examinations for one patient by multiple examinators
Intrarater reliability of PsASon22 and PsASon13
Intrarater reliability will be assessed by performing multiple ultrasound examinations for one patient by multiple examinators
Differences in PsASon22 and PsASon13 change
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)

Full Information

First Posted
September 23, 2019
Last Updated
May 11, 2021
Sponsor
Medical University of Graz
Collaborators
Celgene Corporation, Medical University of Vienna, Medical University Innsbruck
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1. Study Identification

Unique Protocol Identification Number
NCT04102449
Brief Title
Validation of the PsASon ULtrasound Scores in Patients With Psoriatic Arthritis Undergoing TReatment With Apremilast
Acronym
PSA-ULTRA
Official Title
Validation of the PsASon ULtrasound Scores in Patients With Psoriatic Arthritis Undergoing TReatment With Apremilast
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Funding stopped
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
February 2022 (Anticipated)
Study Completion Date
February 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Graz
Collaborators
Celgene Corporation, Medical University of Vienna, Medical University Innsbruck

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriatic Arthritis
Keywords
Ultrasound, Psoriatic arthritis, Outcome measures, Apremilast, Disease activity

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment with Apremilast
Arm Type
Other
Arm Description
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 Type
Drug
Intervention Name(s)
Apremilast
Intervention Description
Single arm receiving Apremilast and ultrasound examinations
Primary Outcome Measure Information:
Title
The difference in the change-score of the PsASon22
Description
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.
Time Frame
4-12-24 months
Title
The difference in the change-score of the PsASon13
Description
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.
Time Frame
4-12-24 months
Secondary Outcome Measure Information:
Title
Convergent construct validity of PsAson22 and PsASon13
Description
Convergent construct validity will be assessed by correlating the ultrasound scores to clinical composite scores (f.e. DAPSA)
Time Frame
4-12-24 months
Title
Sensitivity to Change of PsASon22 and PsASon13
Description
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)
Time Frame
4-12-24 months
Title
Interrater reliability of PsASon22 and PsASon13
Description
Interrater reliability will be assessed by performing multiple ultrasound examinations for one patient by multiple examinators
Time Frame
4-12-24 months
Title
Intrarater reliability of PsASon22 and PsASon13
Description
Intrarater reliability will be assessed by performing multiple ultrasound examinations for one patient by multiple examinators
Time Frame
4-12-24 months
Title
Differences in PsASon22 and PsASon13 change
Description
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)
Time Frame
4-12-24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female patient ≥18 years and <90 years of age PsA according to CASPAR criteria Peripheral manifestation (arthritis, tenosynovitis, dactylitis and/or enthesitis) 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) Written informed consent Exclusion Criteria: Inability to perform US at any site included in the PsASon22 or PsASon13 score (f.e. due to complete destruction of a joint) Planned surgery within the study period or history of surgery of any of the joints to be investigated clinically or by sonography. Contraindication to Apremilast (as per patient information leaflet) Current severe medical illness requiring hospitalization Pregnancy or lactation Inability of the patient to follow the treatment protocol Fulfillment of the MDA Criteria or DAPSA≤14 Current treatment with any investigational drug Current treatment with glucocorticoids at a prednisone equivalent >10mg 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 Change, including dosage changes or discontinuation, of csDMARD treatment (with the exception of leflunomide) in the last 4 weeks before baseline 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.) Current bDMARD, tsDMARD treatment 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rusmir Husic, Dr.
Organizational Affiliation
Medical University of Graz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Graz
City
Graz
State/Province
Styria
ZIP/Postal Code
8010
Country
Austria

12. IPD Sharing Statement

Learn more about this trial

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

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