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

NCT ID: NCT04102449

Last Updated: 2021-05-13

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2022-02-28

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.

Conditions

Psoriatic Arthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Apremilast

Intervention Type: DRUG

Single arm receiving Apremilast and ultrasound examinations

Interventions

Apremilast

Single arm receiving Apremilast and ultrasound examinations

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene Corporation

INDUSTRY

Sponsor Role: collaborator

Medical University of Vienna

OTHER

Sponsor Role: collaborator

Medical University Innsbruck

OTHER

Sponsor Role: collaborator

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rusmir Husic, Dr.

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz

Locations

Medical University of Graz

Graz, Styria, Austria

Countries

Austria

Other Identifiers

AP-CL-PSA-PI-12856

Identifier Type: -

Identifier Source: org_study_id