Erosive OsteoarthritisNCT05683769
microRNA in Erosive Hand Osteoarthritis and Psoriatic Arthritis
An observational study of Erosive Osteoarthritis and Psoriatic Arthritis, run by University of Siena at 1 site in Italy.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 40 to 73 yearsHealthy volunteers can take part
- Conditions the study is for
- Erosive Osteoarthritis, Psoriatic Arthritis
- What is being tested?
- miRNA
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2018to 1 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 73 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population included patients with erosive hand osteoarthritis, patients with psoriatic arthritis and healthy volunteers
Who may be able to join
- For EHOA group:
- Diagnosis of EHOA according to the American College of Rheumatology (ACR) criteria and to the presence of the classical central erosion in at least two IP joints.
- Availability of plain radiography of both hands performed in the previous 6 months. Plain radiographs of both hands were collected and scored by two readers according to Kallman's classificationin a blind observation.
- For PsA group:
- Diagnosis of PsA following the CASPAR classification guidelines
- peripheral arthritis pattern
Show all 11Show fewer
- concomitant diagnosis of psoriasis confirmed by an expert dermatologist
- Naive to conventional and biologic disease-modifying anti-rheumatic drugs (DMARDs) or have withdrawn any DMARDs for at least three months, because of inadequate response or intolerance.
- For control group:
- Healthy volunteers age-and sex-matched to study patients recruited among the hospital staff
- no symptoms or signs attributable to OA, psoriasis, as well as to autoimmune disorders and systemic inflammatory arthropathies.
Who cannot join
- For all subjects:
- other rheumatic and not rheumatic diseases which can affect the functionality of the peripheral joints, as tendinopathies, carpal tunnel syndrome, Dupuytren's contractures, collagen diseases, neurological disorders or arthroplasty of the upper and lower limbs, recent trauma, or surgery of the concerned joints
- presence of inflammatory bowel diseases, liver or kidney diseases, acute or chronic infectious disorders, malignancy in the previous 5 years, pregnancy and breastfeeding.
- treatment with systemic or intra-articular (i.a.) corticosteroids, or with i.a. hyaluronic acid during the last three months.
- treatment with intra-muscular or intra-venous bisphosphonates in the previous 6 months
- For EHOA group:
Show all 9Show fewer
- therapy with Symptomatic Slow Acting Drugs for Osteoarthritis (SYSADOAs) during the previous 6 months.
- For PsA group:
- PsA with pure axial involvement on the basis of inflammatory spinal pain and/or sacroiliac syndrome with spinal or sacroiliac radiographic changes and mixed involvement.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Rheumatology Unit Azienda Ospedaliera Universitaria Senese
Siena, 53100
About this study
Official title: Can microRNA Help to Differentiate Erosive Hand Osteoarthritis From Psoriatic Arthritis?
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.
Read more
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.
- Conditions
- Erosive Osteoarthritis, Psoriatic Arthritis
- Being tested
- miRNA
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
miRNAGenetic
Assessment of miRNA, as potential biomarkers to discriminate erosive hand osteoarthritis from psoriatic arthritis
| Study group | Role | What they receive |
|---|---|---|
| erosive hand osteoarthritis | EHOA was diagnosed according to the American College of Rheumatology (ACR) criteria and to the presence of the classical central erosion in at least two IP joints. Further inclusion criteria were the availability of plain radiography of both hands performed in the previous 6 months. Plain radiographs of both hands were collected and scored by two readers according to Kallman's classification in a blind observation. Receives: Genetic: miRNA | |
| psoriatic arthritis | PsA was diagnosed following the CASPAR classification guidelines and only patients with the peripheral arthritis pattern were considered; all PsA group had also the diagnosis of psoriasis confirmed by an expert dermatologist. These patients had also to be naive to conventional and biologic disease-modifying anti-rheumatic drugs (DMARDs) or have withdrawn any DMARDs for at least three months, because of inadequate response or intolerance. Receives: Genetic: miRNA | |
| Control Group | The control group was represented by healthy volunteers age-and sex-matched to study patients and were recruited among the hospital staff; HC did not exhibit symptoms or signs attributable to OA, psoriasis, as well as to autoimmune disorders and systemic inflammatory arthropathies. Receives: Genetic: miRNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
MicroRNA expression profile
miR-21, miR-140, miR-146a, miR-155, miR-181a, miR-223, miR-23a, miR-26a and miR-let-7e expression in peripheral blood mononuclear cells
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start1 Sep 2018
- Primary completion1 Dec 2021
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erosive OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Siena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, fioravanti antonella, University of Siena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05683769
- Sponsor's protocol ID
- miRNA EHOA vs PsA
- Status last verified
- Feb 2023
- First submitted
- 4 Jan 2023
- Last updated
- 8 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can microRNA Help to Differentiate Erosive Hand Osteoarthritis From Psoriatic Arthritis?
- ClinicalTrials.gov ID
- NCT05683769
- Acronym / sponsor ID
- miRNA EHOA vs PsA
- Conditions
- Erosive Osteoarthritis, Psoriatic Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of SienaUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 13 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| erosive hand osteoarthritis | – | Genetic: miRNAEHOA was diagnosed according to the American College of Rheumatology (ACR) criteria and to the presence of the classical central erosion in at least two IP joints. Further inclusion criteria were the availability of plain radiography of both hands performed in the previous 6 months. Plain radiographs of both hands were collected and scored by two readers according to Kallman's classification in a blind observation. |
| psoriatic arthritis | – | Genetic: miRNAPsA was diagnosed following the CASPAR classification guidelines and only patients with the peripheral arthritis pattern were considered; all PsA group had also the diagnosis of psoriasis confirmed by an expert dermatologist. These patients had also to be naive to conventional and biologic disease-modifying anti-rheumatic drugs (DMARDs) or have withdrawn any DMARDs for at least three months, because of inadequate response or intolerance. |
| Control Group | – | Genetic: miRNAThe control group was represented by healthy volunteers age-and sex-matched to study patients and were recruited among the hospital staff; HC did not exhibit symptoms or signs attributable to OA, psoriasis, as well as to autoimmune disorders and systemic inflammatory arthropathies. |
Who may qualify
- Ages
- 40 to 73 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population included patients with erosive hand osteoarthritis, patients with psoriatic arthritis and healthy volunteers
Key inclusion criteria (11 listed)
- Diagnosis of EHOA according to the American College of Rheumatology (ACR) criteria and to the presence of the classical central erosion in at least two IP joints.
- Availability of plain radiography of both hands performed in the previous 6 months. Plain radiographs of both hands were collected and scored by two readers according to Kallman's classificationin a blind observation.
- Diagnosis of PsA following the CASPAR classification guidelines
- peripheral arthritis pattern
- concomitant diagnosis of psoriasis confirmed by an expert dermatologist
Key exclusion criteria (9 listed)
- other rheumatic and not rheumatic diseases which can affect the functionality of the peripheral joints, as tendinopathies, carpal tunnel syndrome, Dupuytren's contractures, collagen diseases, neurological disorders or arthroplasty of the upper and lower limbs, recent trauma, or surgery of the concerned joints
- presence of inflammatory bowel diseases, liver or kidney diseases, acute or chronic infectious disorders, malignancy in the previous 5 years, pregnancy and breastfeeding.
- treatment with systemic or intra-articular (i.a.) corticosteroids, or with i.a. hyaluronic acid during the last three months.
- treatment with intra-muscular or intra-venous bisphosphonates in the previous 6 months
- therapy with Symptomatic Slow Acting Drugs for Osteoarthritis (SYSADOAs) during the previous 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| miRNAAssessment of miRNA, as potential biomarkers to discriminate erosive hand osteoarthritis from psoriatic arthritis | Genetic | Control Group, erosive hand osteoarthritis, psoriatic arthritis |
Primary outcome
MicroRNA expression profile
Time frame: Baseline
miR-21, miR-140, miR-146a, miR-155, miR-181a, miR-223, miR-23a, miR-26a and miR-let-7e expression in peripheral blood mononuclear cells
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Erosive Osteoarthritis and Psoriatic Arthritis, run by University of Siena at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MicroRNA expression profile (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.