NCT05683769

microRNA in Erosive Hand Osteoarthritis and Psoriatic Arthritis

Completed Last updated 8 February 2023

What this trial tests

trial testing miRNA in Erosive Osteoarthritis in 150 participants. Completed in 1 December 2022.

Timeline

1 September 2018

Primary endpoint
1 December 2021

1 December 2022

Quick facts

Lead sponsor	University of Siena
Status	Completed
Study type	OBSERVATIONAL
Enrollment	150
Start date	1 September 2018
Primary completion	1 December 2021
Estimated completion	1 December 2022
Sites	1 location across Italy

Drugs / interventions tested

• miRNA

Conditions studied

• Erosive Osteoarthritis — all drugs for Erosive Osteoarthritis →
• Psoriatic Arthritis — all drugs for Psoriatic Arthritis →

Sponsor

University of Siena

Who can join

Adults 40 to 73, any sex, with Erosive Osteoarthritis or Psoriatic Arthritis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Erosive osteoarthritis of the hand (EHOA) is a rare subset of HOA that affects mainly postmenopausal middle-aged women, featured by prominent signs of inflammation, severe progression, and typical radiographic changes of the interphalangeal (IP). It is presently debated whether EHOA is an advanced stage of the classical HOA or a separate entity with peculiar inflammatory features, which can mimic chronic arthritis such as psoriatic arthritis (PsA). PsA is a chronic immune-mediated inflammatory arthropathy, that affects 14.0-22.7% of patients with psoriasis. It is a highly heterogeneous disease, whose clinical features often vary from peripheral arthritis, to spinal spondylitis, and/or asymmetrical synovitis, enthesitis, dactylitis. As no gold-standard diagnostic test for PsA exists, the diagnosis is based on different patterns of clinical, radiological and serological markers included in the classification criteria for psoriatic arthritis (CASPAR). Some typical features of PsA are also observed in other chronic musculoskeletal diseases, as rheumatoid arthritis (RA) and HOA, determining possible delay of the diagnosis and consequent influence on the successful results of the therapies. In particular, the differential diagnosis of PsA and EHOA is very challenging, considering that both conditions can be characterized by bone proliferation and inflammation processes in the distal IP joints and lack of specific diagnostic biomarkers.

In the last decade, microRNA (miRNA) are emerged as possible candidate biomarkers in different rheumatic diseases. They are a class of small non-coding RNA molecules implicated in the direct regulation of the expression of different target genes by repressing or inhibiting translation. Mature miRNA are produced inside the cell and exert their function in the cytoplasm, but also by being released into the circulation and body fluids, where they regulate both physiological and pathological processes. Specific profiles of miRNA have been associated with the up-regulation of several inflammatory cytokines or degrading enzymes involved in the pathogenesis of PsA or OA. Indeed, miRNA have been detected in human plasma and in synovial fluid from patients with PsA and are considered possible diagnostic and prognostic biomarkers of this disease; very recently a pattern of circulating miRNAs has been studied also in patients with HOA.

IThe aim of the present study is to test whether miRNA can help to differentiate EHOA from PsA. In detail, the investigators evaluate the expression profile of a series of miRNA (miR-21, miR-140, miR-146a, miR-155, miR-181a, miR-223, miR-23a, miR-26a and miR-let-7e), known to be dysregulated in PsA and OA, in peripheral blood mononuclear cells (PBMCs) of patients with EHOA and PsA and in comparison to a group of healthy controls (HC).

Furthermore, the investigators assess the potential correlation between miRNA expression and disease activity.

Publications & conference data

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

1. MicroRNAs Regulate Function in Atherosclerosis and Clinical Implications.
   Li Z, Zhao Y, Suguro S, Suguro R. · · 2023 · cited 12× · PMID 37675243 · DOI 10.1155/2023/2561509
2. Mechanosensitive miRNAs in Cartilage and Subchondral Bone Remodeling: Emerging Targets for Osteoarthritis Therapy.
   Shang X. · · 2025 · cited 3× · PMID 40703641 · DOI 10.2147/jir.s529149
3. Can Circulating MicroRNAs, Cytokines, and Adipokines Help to Differentiate Psoriatic Arthritis from Erosive Osteoarthritis of the Hand? A Case-Control Study.
   Fioravanti A, Cheleschi S, Cavalier E, Reginster JY, et al · · 2025 · cited 1× · PMID 40429765 · DOI 10.3390/ijms26104621