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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.
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 :
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 between inclusion and 3 years of follow-up and between inclusion and the end of follow-up at 6 years.
To determine the clinical, biological and radiographic factors predictive of the radiographic progression of OA between inclusion and 3 years but also between inclusion and 6 years To investigate whether clinical changes and radiographic structural changes are associated or correlated between inclusion and 3 years of follow-up or between inclusion and 6 years of follow-up To investigate whether clinical status and radiographic alterations are correlated at inclusion To determine whether hand OA is associated with other 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 To perform a cross-sectional analysis of the correlation between clinical tools and erosive radiographic involvement at inclusion (in the population with erosive hand OA at inclusion) ; To evaluate the frequency of fibromyalgia at 3 years of follow-up and at the end of the follow-up at 6 years ; To evaluate the frequency of neuropathic pain at 3 years of follow-up and at the end of the follow-up at 6 years ; To evaluate the pressure pain threshold at 3 years of follow-up and at the end of the follow-up at 6 years.
Methods : Prospective observational study The study will be proposed to all patients viewed at the out-patient clinic for hand OA which took place in Saint-Antoine Hospital in Rheumatology Department since 2004 (usually 12/week). 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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| symptomatic and radiographic hand osteoarthritis | Other | Patients above 35-years old with symptomatic and radiographic hand osteoarthritis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GENETIC and radiographs | Other | GENETIC : Blood sample for genetic analysis will be performed at inclusion in order to built a DNA collection OTHER: Serum samples will be performed at inclusion M0, M36 and M72 for serum biomarkers assessment OTHER : These radiographs will be performed at M0, M36 and M72 |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline clinical, biological, genetic and imaging factors of clinical aggravation after 3 years of follow-up(AUSCAN VA3.0) | Australian/Canadian Hand Osteoarthritis Index (AUSCAN VA3.0), Functional Index for Hand OA (FIHOA), modified short-form of Score for the Assessment and quantification of Chronic Rheumatic Affections of the Hands (M-Short Form-SACRAH), Arthritis Impact Measurement Scales (AIMS2), Health Questionnaire Assessment (HAQ), Hospital Anxiety and Depression Scale (HAD), Cochin index, Doyle index, synovial count, Heberden nodes count, Bouchard nodes count, grip strength, pinch strength, pain VAS, function VAS and aesthetic VAS at 6 years. | 6 years |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline clinical, biological, genetic and imaging factors of clinical aggravation after 3 years of follow-up(AUSCAN VA3.0) | association or correlation between clinical changes and radiographic structural changes between inclusion and 3 years of follow-up or between inclusion and 6 years of follow up | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francis Berenbaum, PU PH | Assistance publique | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Rhumatologie - Hôpital Saint-Antoine | Paris | 75012 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36931384 | Derived | Cambon-Binder A, Jaisson S, Tuffet S, Courties A, Eymard F, Okwieka A, Gillery P, Miquel A, Rousseau A, Crema MD, Berenbaum F, Sellam J. Serum carboxymethyllysine concentration is associated with erosive hand osteoarthritis. Osteoarthritis Cartilage. 2023 Jul;31(7):976-984. doi: 10.1016/j.joca.2023.03.006. Epub 2023 Mar 15. | |
| 36263851 |
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| ID | Term |
|---|---|
| D014965 | X-Rays |
| ID | Term |
|---|---|
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
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|
| Kallman score, Verbruggen score, Kellgren-Lawrence grading and OARSI scoring (Altman score) |
| 3 and 6 years |
| patients above 35 years old with symptomatic and radiographic hand osteoarthritis | 6 years |
| Binvignat M, Pires G, Tchitchek N, Costantino F, Courties A, Klatzmann D, Butte AJ, Combe B, Dougados M, Richette P, Mariotti-Ferrandiz E, Berenbaum F, Sellam J. Identification of Symptom Phenotypes of Hand Osteoarthritis Using Hierarchical Clustering: Results From the DIGICOD Cohort. Arthritis Care Res (Hoboken). 2023 Jul;75(7):1494-1502. doi: 10.1002/acr.25047. Epub 2023 Jan 25. |
| D011827 | Radiation |
| D011839 | Radiation, Ionizing |