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A Prospective Cohort Study of Patients Suffering From Hand Osteoarthritis Symptoms (COARDIG)

University Hospital Center (CHU) logo

University Hospital Center (CHU)

Status

Enrolling

Conditions

Hand Osteoarthritis

Treatments

Diagnostic Test: Identification of subgroups of patients with early AD with risk of progression

Study type

Interventional

Funder types

Other

Identifiers

NCT03650673
RECHMPL17_0391
2017-A03378-45 (Registry Identifier)

Details and patient eligibility

About

The late-stage forms of degenerative osteoarthritis (OA) are very debilitating and less affordable to therapy. The main objective is to identify early onset symptoms of hand OA patients through imaging techniques (such as ultrasound and MRI). Our primary endpoint is to specify patients with high risk of radiological profression (X-ray).

Enrollment

150 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

- Early digital osteoarthritis must combine the clinical AND radiological definition.

Clinical definition:

At least one of the following 4 criteria: Pain or stiffness or swelling or deformity of a digital joint (IPP and / or IPD) A breach of at least one PPI and / or IPD Age under 60 at the time of the first symptoms Clinical symptoms have been changing for less than 3 years

Radiographic definition:

The presence of the achievement of at least one PPI and / or IPD. Presence of at least two of the following three criteria: pinching, marginal subchondral condensation, marginal osteophyte Erosion on radiography is not an exclusion criteria

- Consent form signed

Exclusion criteria

  • patients suffering from rheumatoid arthritis, rheumatoid psoriasis or any other inflammatory rheumatism
  • patients suffering from metabolic diseasis such as gout, hemochromatosis, Wilson's disease; or from congenital disease such as displasie, osteogenesis,
  • Presence of advanced radiographic osteoarthritis based in Kellgreen Lawrence score (=4) in one joint among the 10 previous sites.
  • Not able to provide a sample of blood for any reasons
  • MRI contraindication
  • Being in exclusion period determined by another previous study
  • Subject non affiliated to social insurance
  • Pregnant or lactating women
  • Vulnerable people based in L1121-5 article of CSP
  • Elderly subject or protected subjects disabled to give their consent
  • Subjects private of freedom by court or administrative order

Trial design

Primary purpose

Health Services Research

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

150 participants in 1 patient group

Diagnostic Test: Identification of subgroups of patients with
Other group
Treatment:
Diagnostic Test: Identification of subgroups of patients with early AD with risk of progression

Trial contacts and locations

1

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Central trial contact

Yves-Marie PERS, MD

Data sourced from clinicaltrials.gov

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