drugset / Trial / NCT02662985
Study of Power Doppler Ultrasound (PDUS) to Measure Response of Secukinumab Treatment in Patients With Active Psoriatic Arthritis (PsA)
RandomizedParallel-groupTriple-blindTreatment
Summary
This study was designed to leverage the sensitivity of ultrasonography available in clinical practice setting to better describe the time course of response to secukinumab (150 mg and 300 mg) on joint synovitis and enthesitis in PsA patients with an inadequate response to non-biologic DMARDs. PDUS changes in joint synovitis will be assessed using the global Outcome Measures in Rheumatology (OMERACT)-European League against Rheumatism (EULAR) synovitis score (GLOESS) and changes in joint enthesitis were assessed using the OMERACT enthesitis score.
Timeline
- Start
- 2016-08-22
- Primary completion
- 2020-11-10
- Completion
- 2020-11-10
Publications
- D'Agostino MA, Conaghan PG, Gaillez C, Boers M, Naredo E, Mandl P, Carron P, Lopez-Rdz A, Burgos-Vargas R, Rosa J, Bakewell C, Cazenave T, Bao W, Demanse D, Schett G. Exploring clusters based on ultrasound-detected inflammation in patients with psoriatic arthritis: a post-hoc analysis from the ULTIMATE trial. BMC Musculoskelet Disord. 2026 Jan 30;27(1):106. doi: 10.1186/s12891-025-09434-w.
- D'Agostino MA, Schett G, Lopez-Rdz A, Senolt L, Fazekas K, Burgos-Vargas R, Maldonado-Cocco J, Naredo E, Carron P, Duggan AM, Goyanka P, Boers M, Gaillez C. Response to secukinumab on synovitis using Power Doppler ultrasound in psoriatic arthritis: 12-week results from a phase III study, ULTIMATE. Rheumatology (Oxford). 2022 May 5;61(5):1867-1876. doi: 10.1093/rheumatology/keab628.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Secukinumab | Monoclonal antibody | 150 mg | Subcutaneous |
| Comparator | Secukinumab | Monoclonal antibody | 300 mg | Subcutaneous |