NCT03330769: UPSTREAM

Ultrasound in Psoriatic Arthritis Treatment

Status unknown Last updated 17 April 2019

What this trial tests

trial testing New course of treatment in Arthritis, Psoriatic in 250 participants. Status unknown.

Timeline

3 February 2017

Primary endpoint
28 February 2020

29 February 2020

Quick facts

Lead sponsor	University of Cagliari
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	250
Start date	3 February 2017
Primary completion	28 February 2020
Estimated completion	29 February 2020
Sites	4 locations across Italy

Drugs / interventions tested

• New course of treatment — full drug profile →

Conditions studied

• Arthritis, Psoriatic — all drugs for Arthritis, Psoriatic →
• Ultrasonography — all drugs for Ultrasonography →
• Minimal Disease, Residual — all drugs for Minimal Disease, Residual →

Sponsor

University of Cagliari

Who can join

18 and older, any sex, with Arthritis, Psoriatic or Ultrasonography. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

BACKGROUND Psoriatic arthritis (PsA) is a systemic inflammatory disease with articular and extra-articular features. Establishing the prognosis of a patient with PsA is hence important to define the treatment strategy. Currently, observational and prospective cohort studies have identified prognostic factors correlating with the achievement of therapeutic response. Nevertheless, despite the importance of identifying prognostic factors in a disease with a functional disability comparable to rheumatoid arthritis, the studies are still limited.

PRIMARY OBJECTIVE In PsA with clinically active joint disease starting a new course of therapy, to evaluate the additional value of UltraSound(US)-score over clinical examination in detecting patients achieving MDA at 6 months.

STUDY DESIGN The study follows a multi-centre observational prospective cohort study design.

PATIENTS AND METHODS INCLUSION CRITERIA

* Adult \> 18 years of age with PsA (PsA according to the ClASsification criteria for Psoriatic Arthritis (CASPAR) - with joint involvement)
* At least one joint clinically involved (both swelling and tenderness);
* prescription of new course of d NSAIDs (monotherapy), steroid intra-articular injections (monotherapy), conventional Disease-Modifying AntiRheumatic Drugs (DMARDs), biologic DMARDs, including switches or dose augmentations indicated by the treating rheumatologist according to usual clinical practice before US acquisition;
* Stable treatment before treatment modification (6 weeks);
* Signed informed consent form.

CLINICAL ASSESSMENT Patient's clinical assessment will be performed according to the core set of domains for PsA proposed by the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) and Outcome Measures in Rheumatology (OMERACT).

ULTRASOUND ASSESSMENT Sonographic evaluations will be performed by expert ultrasonographers in 44 joints, 36 tendons, 12 entheses and 2 bursae according to the score developed for psoriatic arthritis by the study group ultrasound of the Italian Society of Rheumatology (US-score PsA-SIR)

EXPECTED RESULTS AND SIGNIFICANCE The aim of this study is to identify clinical and US predictors of achieving MDA in PsA patients with active peripheral arthritis starting a new course of therapy.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Recent Advances in Imaging for Diagnosis, Monitoring, and Prognosis of Psoriatic Arthritis.
   Fassio A, Matzneller P, Idolazzi L. · · 2020 · cited 13× · PMID 33195301 · DOI 10.3389/fmed.2020.551684
2. Clinical and ultrasonographic predictors for achieving minimal disease activity in patients with psoriatic arthritis: the UPSTREAM (Ultrasound in PSoriatic arthritis TREAtMent) prospective observational study protocol.
   Canzoni M, Piga M, Zabotti A, Scirè CA, et al · · 2018 · cited 13× · PMID 29991631 · DOI 10.1136/bmjopen-2018-021942
3. Ultrasound for assessing disease activity and structural damage in psoriatic arthritis: the UPsA scores from a multicentre study by the Italian Society of Rheumatology.
   Zabotti A, Piga M, Piga M, Canzoni M, et al · · 2026 · PMID 41314909 · DOI 10.1016/j.ard.2025.10.032