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