Arthrosis of HandDIGICODNCT01831570
DIGItal Cohort Osteoarthritis Design
A study testing GENETIC and radiographs in people with Arthrosis of Hand, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Arthrosis of Hand
- What is being tested?
- GENETIC and radiographs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2013to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- Inflammatory rheumatic destructive disorders (psoriatic arthritis, rheumatoid arthritis)
- Polyarthritis related to gout or chondrocalcinosis involving hand
- Secondary hand OA related to infection or traumatism
- Secondary OA related to genetic dysplasia
- Pregnancy and feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective 6 Years Follow up of Patients With Hand Osteoarthritis
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).
Read more
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.
Read the detailed description
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
- Conditions
- Arthrosis of Hand
- Being tested
- GENETIC and radiographs
- Keywords
- Hand osteoarthritis, predictive factors, erosive hand OA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GENETIC and radiographsOther
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
| Study group | Role | What they receive |
|---|---|---|
| symptomatic and radiographic hand osteoarthritis | Other | Patients above 35-years old with symptomatic and radiographic hand osteoarthritis Receives: Other: GENETIC and radiographs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 years
Secondary outcomes (3)
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
Measured: 3 years
Kallman score, Verbruggen score, Kellgren-Lawrence grading and OARSI scoring (Altman score)
Measured: 3 and 6 years
patients above 35 years old with symptomatic and radiographic hand osteoarthritis
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Arthrosis of HandStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francis Berenbaum, PU PH, Principal investigator, Assistance publique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01831570
- Sponsor's protocol ID
- K110301
- Acronym
- DIGICOD
- Status last verified
- Apr 2025
- First submitted
- 29 Mar 2013
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 36931384Binvignat 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.
PubMed 36263851
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective 6 Years Follow up of Patients With Hand Osteoarthritis
- ClinicalTrials.gov ID
- NCT01831570
- Acronym / sponsor ID
- DIGICOD / K110301
- Conditions
- Arthrosis of Hand
- Keywords
- Hand osteoarthritis, predictive factors, erosive hand OA
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Apr 2013 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 15 Apr 2013 (estimated)
- 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.
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 :
- 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.
Detailed description
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| symptomatic and radiographic hand osteoarthritis | Other | Other: GENETIC and radiographsPatients above 35-years old with symptomatic and radiographic hand osteoarthritis |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- Inflammatory rheumatic destructive disorders (psoriatic arthritis, rheumatoid arthritis)
- Polyarthritis related to gout or chondrocalcinosis involving hand
- Secondary hand OA related to infection or traumatism
- Secondary OA related to genetic dysplasia
- Pregnancy and feeding
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 |
|---|---|---|
| GENETIC and radiographsGENETIC : 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 | Other | symptomatic and radiographic hand osteoarthritis |
Primary outcome
Baseline clinical, biological, genetic and imaging factors of clinical aggravation after 3 years of follow-up(AUSCAN VA3.0)
Time frame: 6 years
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.
3 secondary outcomes
Baseline clinical, biological, genetic and imaging factors of clinical aggravation after 3 years of follow-up(AUSCAN VA3.0)
Time frame: 3 years
Kallman score, Verbruggen score, Kellgren-Lawrence grading and OARSI scoring (Altman score)
Time frame: 3 and 6 years
patients above 35 years old with symptomatic and radiographic hand osteoarthritis
Time frame: 6 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Derived from this study: PubMed 36931384Cambon-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.
- Derived from this study: PubMed 36263851Binvignat 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.
- Individual participant dataSharing planned: No
Related trials for Arthrosis of Hand
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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.
Francis Berenbaum, PU PH principal investigator
Assistance publique
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GENETIC and radiographs in people with Arthrosis of Hand, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 3 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 2 Apr 2025. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
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?
Baseline clinical, biological, genetic and imaging factors of clinical aggravation after 3 years of follow-up(AUSCAN VA3.0) (time frame: 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01831570, which also lists 2 linked publications.
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 2 Apr 2025; AzTrials last refreshed its copy on 30 Oct 2026.