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

NCT04102449 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: AP-CL-PSA-PI-12856
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriatic Arthritis

Keywords

Ultrasound; Psoriatic arthritis; Outcome measures; Apremilast; Disease activity

Outcome Measures

Primary Outcomes (2)

• 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.

  4-12-24 months

• 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.

  4-12-24 months

Secondary Outcomes (5)

• Convergent construct validity of PsAson22 and PsASon13

  4-12-24 months

• Sensitivity to Change of PsASon22 and PsASon13

  4-12-24 months

• Interrater reliability of PsASon22 and PsASon13

  4-12-24 months

• Intrarater reliability of PsASon22 and PsASon13

  4-12-24 months

• Differences in PsASon22 and PsASon13 change

  4-12-24 months

Study Arms (1)

Treatment with Apremilast

OTHER

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

Interventions

Apremilast DRUG

Single arm receiving Apremilast and ultrasound examinations

Treatment with Apremilast

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medical University of Graz: lead
• Celgene Corporation: collaborator
• Medical University of Vienna: collaborator
• Medical University Innsbruck: collaborator

Study Sites (1)

Medical University of Graz

Graz, Styria, 8010, Austria

Location

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

apremilast

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Rusmir Husic, Dr.

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2019
• First Posted: September 25, 2019
• Study Start: July 1, 2020
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: May 13, 2021

Record last verified: 2021-05

Locations

AU (1)