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Active, not recruitingNo phase

DIGItal Cohort Osteoarthritis Design

Key facts

Who runs it
Assistance Publique - Hôpitaux de Paris
Where
France1 site in 1 countryChoose a country to see its sites
Trial code
Status
Active, not recruiting
People taking part
500 people, planned
Started
Apr 2013
Expected to end
Jun 2027
Type of study
Interventional
Treatments tested
  • GENETIC and radiographs
Record updated
2 April 2025

Who can take part

Age
35 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

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Who can take part

  • Patients above 35-years old, having hand OA according to one of the following definitions:
  • symptomatic hand OA fulfilling ACR criteria on at least 2 joints among proximal interphalangeal, distal interphalangeal joints or 1st interphalangeal joint with Kellgren-Lawrence > 2
  • symptomatic thumb base OA with Kellgren-Lawrence > 2

Who cannot take part

  • Inflammatory rheumatic destructive disorders (psoriatic arthritis, rheumatoid arthritis)
  • Secondary hand OA related to infection or traumatism
  • Polyarthritis related to gout or chondrocalcinosis involving hand
  • Secondary OA related to genetic dysplasia
  • Pregnancy and feeding

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

Introduction Osteoarthritis is a chronic disease characterized by a progressive degradation of articular cartilage. Hand OA involves symptomatically more than 1 million of subjects in France (i.e., painful or with functional impairment). To date, the treatment of OA is only symptomatic and no drugs are able to stop the degradative process of cartilage.

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50% of patients with hand OA exhibit a functional impairment responsible for a severe handicap, which is almost similar to rheumatoid arthritis. While the risk factors of hand OA are well identified (i.e., familial history, female sex, menopause, obesity), clinical outcome in large cohort is poorly known. In addition, the investigators miss predictive clinical, biological or imaging factors of severe clinical (i.e. pain, functional impairment or aesthetic damage) or structural evolution (i.e., aggravation of radiographic scores).

Primary objective To investigate in hand OA patients predictive clinical, biological, genetic and imaging factors of clinical aggravation after 6 years of follow-up.

Secondary objectives To investigate in hand OA patients predictive clinical, biological, genetic and imaging factors of clinical aggravation after 3 years of follow-up.

To investigate in hand OA patients predictive clinical, biological, genetic and imaging factors of clinical aggravation after 3 years of follow-up.

To investigate whether variations of clinical evaluation of hand hand OA and radiographic structural changes are associated or correlated between inclusion and 3 years of follow-up or between inclusion and 6 years follow-up To investigate whether clinical status and radiographic alterations are correlated at inclusion To determine whether hand OA is associated with OA at other sites or with other hand diseases (carpal tunnel syndrome, tendinitis) To evaluate frequency of erosive hand OA among the whole hand OA cohort at inclusion, at 3 and 6 years of follow-up To identify clinical, biological, genetic and imaging factors associated with erosive hand OA (versus non erosive hand OA) at inclusion or during the follow up (3 and 6 years) To investigate predictive clinical, biological, genetic and imaging factors of clinical or radiographic aggravation after 3 or 6 years of follow-up in the erosive hand OA subgroup

Methods :

the investigators plan to include 500 patients in the cohort (5/week) 7 visits (one per year) are planned: M0, M12, M24, M36, M48, M60 and M72. A clinical evaluation of hand OA will be performed at each visit. At visit M0, M36 and M72, hand radiographs and radiographs of other OA localisation (if symptomatic) will be performed.

A blood sample will be taken at inclusion for biomarker studies and genetic investigations.

A blood sample will be taken at M36 and M72 to build a prospective serum collection.

Duration of the study: 8.5 years with 2.5 years of inclusion period Duration of the study for one patient: 6 years Recruitment at the Rheumatology Department of Saint-Antoine Hospital with a multicentric international steering committee

Potential outcomes :

* Identification of clinical, radiological and biological tools useful to predict clinical and structural outcomes * Description of the history course of hand OA and predictive factors of severe evolution (i.e. erosive form of hand OA) To integrate in daily practice, clinical and radiological tools allowing a standardized follow up of hand OA patients.

The group in the trial

  • symptomatic and radiographic hand osteoarthritisOther group

    Patients above 35-years old with symptomatic and radiographic hand osteoarthritis

    Treatment: GENETIC and radiographs

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Prospective 6 Years Follow up of Patients With Hand Osteoarthritis
Record updated
2 April 2025