Knee OsteoarthritisBIOGONCT06600958
IDENTIFICATION OF BIOMARKERS ASSOCIATED WITH THE SEVERITY AND RADIO-CLINICAL PROGRESSION OF KNEE OSTEOARTHRITIS
An observational study of Knee Osteoarthritis and Chronic Inflammatory Rheumatism, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Knee osteoarthritis (OA) is an heterogeneous disease, both symptomatically and structurally, with very different evolving profiles. Although several serum, urinary or synovial biomarkers have been developed in knee OA, their interest as potential predictive factors of clinical and structural progression remains poorly… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis, Chronic Inflammatory Rheumatism
- What is being tested?
- SA brief descriptive name used to refer to the intervention(s) studied
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 3 Nov 2022to 3 Nov 2042
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients consulting the department for puncture and/or infiltration for gonalgia in the context of knee osteoarthritis or knee arthritis related to chronic inflammatory rheumatism.
Who may be able to join
- - Male or female
- Age ≥ 18 years
- Information and consent of the patient or of a third person in case of physical incapacity to sign the consent form
- Unilateral or bilateral symptomatic knee OA (both knees may be included at the same time or at different times) regardless of the level of pain, confirmed radiologically by X-ray dating less than one year [(Kellgren and Lawrence score ≥2 in at least one of the 3 compartments (medial, lateral or patellofemoral)] or arthritis of the knee related to a spondyloarthritis or rheumatoid arthritis
- Registered at the social security system
Who cannot join
- Male or female
- Age ≥ 18 years
- Information and consent of the patient or of a third person in case of physical incapacity to sign the consent form
- Unilateral or bilateral symptomatic knee OA (both knees may be included at the same time or at different times) regardless of the level of pain, confirmed radiologically by X-ray dating less than one year [(Kellgren and Lawrence score ≥2 in at least one of the 3 compartments (medial, lateral or patellofemoral)] or arthritis of the knee related to a spondyloarthritis or rheumatoid arthritis
- Registered at the social security system
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: IDENTIFICATION OF BIOMARKERS ASSOCIATED WITH THE SEVERITY AND RADIO-CLINICAL PROGRESSION OF KNEE OSTEOARTHRITIS: OBSERVATIONAL STUDY AND BIOLOGICAL COLLECTION FROM JOINT ARTHROCENTESIS TO JOINT PLACEMENT
Knee osteoarthritis (OA) is an heterogeneous disease, both symptomatically and structurally, with very different evolving profiles. Although several serum, urinary or synovial biomarkers have been developed in knee OA, their interest as potential predictive factors of clinical and structural progression remains poorly known. Similarly, to date, no biological predictive markers of response to OA treatments have been validated, particularly for intra-articular treatments [corticosteroids (CTC), hyaluronic acid (HA), platelet-rich plasma (PRP)]. Finally, although cohorts of OA patients have already been established in the past, none of them has made it possible to establish a biobank of serum and synovial fluid obtained from the same patient at inclusion but also during the follow-up of the OA disease, up to the joint replacement.
The investigators hypothesize that some biomarkers in serum, PRP and synovial fluid in knee OA:
Read more
- are be correlated with the clinical symptoms and radiological lesions, thus allowing to define distinct clusters of patients whose clinical and radiological evolving profile could be different
- are correlated with the clinical evolution (pain and functional limitation)
- can predict the radiographic progression but also in the long term the necessity of joint replacement
- could constitute predictive factors of response to intra-articular treatments (CTC, HA and PRP).
To validate theses hypothesis, investigators will conduct a longitudinal cohort study with long term follow-up until joint replacement in patients with knee OA. In parallel to this longitudinal study, a cross-sectional ancillary study will be conducted to compare the levels of different serum and synovial biomarkers between subjects with knee OA and subjects with chronic inflammatory rheumatism (rheumatoid arthritis, spondylarthritis)
A/ Main objectives:
- Longitudinal study To study the correlations between changes in clinical symptoms (pain, function, quality of life, effusion, flare-up) / radiographic progression during the follow-up on the one hand, and the levels of biomarkers in serum, PRP and synovial fluid at inclusion / their variations at different times of the study on the other hand.
B/ Secondary objectives
- Longitudinal study
- To study the correlations between clinical (pain, function, quality of life, effusion, congestive flare) / radiographic phenotype on the one hand, and serum, PRP, and synovial biomarker values at each follow-up visit.
- To assess the prognostic value of clinical, biological or clinico-biological clusters on the ultimate outcome of OA defined by joint replacement.
- To assess the prognostic value of different serum and synovial biomarkers on the structural progression during the follow-up.
- To assess the prognostic value of different serum and synovial biomarkers on the efficacy of different intra-articular treatments (CTC, HA, PRP)
- To assess changes of clinical symptoms, radiological grades and biological markers after different intra-articular treatments (CTC, HA, PRP)
- To study the distribution of cellular populations in the joint fluid (synoviocytes, macrophages, lymphocytes, mesenchymal stem cells) according to the clinical and radiographic phenotype
- To assess the correlations between the level of different biomarkers in serum, synovial fluid and their levels on tissue samples from OA joint obtained during joint replacement.
- To study in vitro the effect of purified glycosamninoglycan (GAG) from synovial fluid and PRP on the metabolism of synoviocytes, macrophages and mesenchymal stem cells from autologous synovial fluid
- To study in vitro the effect of purified GAGs from synovial fluid and PRP on the metabolism of synoviocytes, chondrocytes, mesenchymal stem cells obtained from human joint tissue samples (synovial membrane, cartilage) obtained during joint replacement.
- Cross-sectional study
- To assess the correlations between clinical symptoms (pain, function, quality of life, effusion, congestive flare) and radiographic phenotype and serum and synovial biomarkers at inclusion.
- To compare serum and synovial biomarkers between subjects with knee OA and those with chronic inflammatory rheumatism (rheumatoid arthritis, spondyloarthritis) at inclusion.
Method:
300 patients with knee pain related to knee OA (n=200) or chronic inflammatory rheumatism (spondylarthritis and rheumatoid arthritis) (n=100) requiring arthrocentesis and/or intra-articular injection will be enrolled in the Rheumatology department from Henri Mondor Hospital. A longitudinal follow-up will be proposed to patients with knee OA in addition to the participation in the cross-sectional study. The follow-up will include at least one visit each year or more in case of painful flare-up or new intra-articular injection. The follow-up will last a maximum of 10 years or less in case of joint replacement.
- Being tested
- SA brief descriptive name used to refer to the intervention(s) studied
- Keywords
- Observational study, Knee osteoarthritis, Inflammatory rheumatism, Intra-articular injection, Platelet rich plasma, Hyaluronic acid, corticosteroid
- Medical subject headings
- Osteoarthritis, Knee, Rheumatic Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SA brief descriptive name used to refer to the intervention(s) studiedOther
Details that can be made public about the intervention
| Study group | Role | What they receive |
|---|---|---|
| patients with knee osteoarthritis | Not described Receives: Other: SA brief descriptive name used to refer to the intervention(s) studied | |
| patients with knee arthritis related to chronic inflammatory rheumatism | Not described Receives: Other: SA brief descriptive name used to refer to the intervention(s) studied |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of pain on a 0-100mm VAS from baseline clinical phenotype of OA patients through study completion
performed at baseline, each year (annual visit) up to 10 years but also each time a new knee arthrocentesis or injection
Measured: 10 years
Evaluation of the radiological phenotype
performed at baseline, each year (annual visit) up to 10 years but also each time a new knee arthrocentesis or injection
Measured: 10 years
Changes of WOMAC score A, B, C and WOMAC total from baseline clinical phenotype of OA patients through study completion
performed at baseline, each year (annual visit) up to 10 years but also each time a new knee arthrocentesis or injection
Measured: 10 years
Changes of Lequesne score from baseline clinical phenotype of OA patients through study completion
performed at baseline, each year (annual visit) up to 10 years but also each time a new knee arthrocentesis or injection
Measured: 10 years
Changes of quality of life index defined by EQ5D-5L from baseline clinical phenotype of OA patients through study completion
performed at baseline, each year (annual visit) up to 10 years but also each time a new knee arthrocentesis or injection
Measured: 10 years
Changes of KOFUS score from baseline clinical phenotype of OA patients through study completion
performed at baseline, each year (annual visit) up to 10 years but also each time a new knee arthrocentesis or injection
Measured: 10 years
Changes of DN4 Neuropathic Pain Score from baseline clinical phenotype of OA patients through study completion
performed at baseline, each year (annual visit) up to 10 years but also each time a new knee arthrocentesis or injection
Measured: 10 years
Obtention of an acceptable Symptom State assessed by the PASS (Patient Acceptable Symptom State) through study completion
performed at baseline, each year (annual visit) up to 10 years but also each time a new knee arthrocentesis or injection
Measured: 10 years
Occurrence of a clinical extension of OA disease (presence of a generalized disease in case of association of knee and hand OA) through study completion
performed at baseline, each year (annual visit) up to 10 years but also each time a new knee arthrocentesis or injection
Measured: 10 years
Worsening of radiographic lesions from baseline through study completion assessed by X-rays of the knees (frontal, lateral, Schuss and patellofemoral views) according to the Kellgren and Lawrence score
performed at baseline, every 2 years up to 10 years but also in case of congestive or painful flare-ups in target knee according to the Kellgren and Lawrence score
Measured: 10 years
Analysis of several blood markers [cartilage degradation markers (CTXII, col2-1, col2-1No), anabolic markers (PIIANP), cytokines (IL-6 and IL-8), ultra-sensitive CRP, proteoglycans (PG), glycosaminoglycans (GAG)]
performed at baseline but also each time a new knee arthrocentesis or injection will be performed through study completion
Measured: 10 years
Analysis of several biological markers obtained from PRP [growth factors (FGF, TGF, PDGF, VEGF, IGF,...) and GAGs]
performed at baseline but also each time a new knee arthrocentesis or injection will be performed through study completion
Measured: 10 years
Analysis of several biological markers obtained from synovial fluid [inflammatory cytokines IL-6 and IL-8, PG, GAG, metalloproteinases (MMP)].
performed at baseline but also each time a new knee arthrocentesis or injection will be performed through study completion
Measured: 10 years
Secondary outcomes (6)
Assessment of pain on a VAS 0-100mm for patients with knee OA
performed at baseline, each year (annual visit) up to 10 years but also each time a new knee arthrocentesis or injection
Measured: 10 years
Assessment of the effusion for patients with knee OA
performed at baseline, each year (annual visit) up to 10 years but also each time a new knee arthrocentesis or injection
Measured: 10 years
Assessment of the WOMAC score A, B, C and WOMAC total for patients with knee OA
performed at baseline, each year (annual visit) up to 10 years but also each time a new knee arthrocentesis or injection
Measured: 10 years
Assessment of the Lequesne score for patients with knee OA
performed at baseline, each year (annual visit) up to 10 years but also each time a new knee arthrocentesis or injection
Measured: 10 years
Assessment of the quality of life index defined by EQ5D-5L for patients with knee OA
performed at baseline, each year (annual visit) up to 10 years but also each time a new knee arthrocentesis or injection
Measured: 10 years
Assessment of the KOFUS flare score for patients with knee OA
performed at baseline, each year (annual visit) up to 10 years but also each time a new knee arthrocentesis or injection
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start3 Nov 2022
- Primary completion3 Nov 2042 (estimated)
- Study completion3 Nov 2042 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florent EYMARD, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06600958
- Sponsor's protocol ID
- AP-HP220546
- Acronym
- BIOGO
- Status last verified
- Jan 2026
- First submitted
- 21 Nov 2022
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IDENTIFICATION OF BIOMARKERS ASSOCIATED WITH THE SEVERITY AND RADIO-CLINICAL PROGRESSION OF KNEE OSTEOARTHRITIS: OBSERVATIONAL STUDY AND BIOLOGICAL COLLECTION FROM JOINT ARTHROCENTESIS TO JOINT PLACEMENT
- ClinicalTrials.gov ID
- NCT06600958
- Acronym / sponsor ID
- BIOGO / AP-HP220546
- Keywords
- Observational study, Knee osteoarthritis, Inflammatory rheumatism, Intra-articular injection, Platelet rich plasma, Hyaluronic acid, corticosteroid
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 3 Nov 2022 (actual)
- Primary completion
- 3 Nov 2042 (estimated)
- Study completion
- 3 Nov 2042 (estimated)
- First posted
- 19 Sep 2024 (actual)
- 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.
Knee osteoarthritis (OA) is an heterogeneous disease, both symptomatically and structurally, with very different evolving profiles. Although several serum, urinary or synovial biomarkers have been developed in knee OA, their interest as potential predictive factors of clinical and structural progression remains poorly known. Similarly, to date, no biological predictive markers of response to OA treatments have been validated, particularly for intra-articular treatments [corticosteroids (CTC), hyaluronic acid (HA), platelet-rich plasma (PRP)]. Finally, although cohorts of OA patients have already been established in the past, none of them has made it possible to establish a biobank of serum and synovial fluid obtained from the same patient at inclusion but also during the follow-up of the OA disease, up to the joint replacement.
The investigators hypothesize that some biomarkers in serum, PRP and synovial fluid in knee OA:
- are be correlated with the clinical symptoms and radiological lesions, thus allowing to define distinct clusters of patients whose clinical and radiological evolving profile could be different
- are correlated with the clinical evolution (pain and functional limitation)
- can predict the radiographic progression but also in the long term the necessity of joint replacement
- could constitute predictive factors of response to intra-articular treatments (CTC, HA and PRP).
To validate theses hypothesis, investigators will conduct a longitudinal cohort study with long term follow-up until joint replacement in patients with knee OA. In parallel to this longitudinal study, a cross-sectional ancillary study will be conducted to compare the levels of different serum and synovial biomarkers between subjects with knee OA and subjects with chronic inflammatory rheumatism (rheumatoid arthritis, spondylarthritis)
A/ Main objectives:
- Longitudinal study To study the correlations between changes in clinical symptoms (pain, function, quality of life, effusion, flare-up) / radiographic progression during the follow-up on the one hand, and the levels of biomarkers in serum, PRP and synovial fluid at inclusion / their variations at different times of the study on the other hand.
B/ Secondary objectives
- Longitudinal study
- To study the correlations between clinical (pain, function, quality of life, effusion, congestive flare) / radiographic phenotype on the one hand, and serum, PRP, and synovial biomarker values at each follow-up visit.
- To assess the prognostic value of clinical, biological or clinico-biological clusters on the ultimate outcome of OA defined by joint replacement.
- To assess the prognostic value of different serum and synovial biomarkers on the structural progression during the follow-up.
- To assess the prognostic value of different serum and synovial biomarkers on the efficacy of different intra-articular treatments (CTC, HA, PRP)
- To assess changes of clinical symptoms, radiological grades and biological markers after different intra-articular treatments (CTC, HA, PRP)
- To study the distribution of cellular populations in the joint fluid (synoviocytes, macrophages, lymphocytes, mesenchymal stem cells) according to the clinical and radiographic phenotype
- To assess the correlations between the level of different biomarkers in serum, synovial fluid and their levels on tissue samples from OA joint obtained during joint replacement.
- To study in vitro the effect of purified glycosamninoglycan (GAG) from synovial fluid and PRP on the metabolism of synoviocytes, macrophages and mesenchymal stem cells from autologous synovial fluid
- To study in vitro the effect of purified GAGs from synovial fluid and PRP on the metabolism of synoviocytes, chondrocytes, mesenchymal stem cells obtained from human joint tissue samples (synovial membrane, cartilage) obtained during joint replacement.
- Cross-sectional study
- To assess the correlations between clinical symptoms (pain, function, quality of life, effusion, congestive flare) and radiographic phenotype and serum and synovial biomarkers at inclusion.
- To compare serum and synovial biomarkers between subjects with knee OA and those with chronic inflammatory rheumatism (rheumatoid arthritis, spondyloarthritis) at inclusion.
Method:
300 patients with knee pain related to knee OA (n=200) or chronic inflammatory rheumatism (spondylarthritis and rheumatoid arthritis) (n=100) requiring arthrocentesis and/or intra-articular injection will be enrolled in the Rheumatology department from Henri Mondor Hospital. A longitudinal follow-up will be proposed to patients with knee OA in addition to the participation in the cross-sectional study. The follow-up will include at least one visit each year or more in case of painful flare-up or new intra-articular injection. The follow-up will last a maximum of 10 years or less in case of joint replacement.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with knee osteoarthritis | – | Other: SA brief descriptive name used to refer to the intervention(s) studied |
| patients with knee arthritis related to chronic inflammatory rheumatism | – | Other: SA brief descriptive name used to refer to the intervention(s) studied |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients consulting the department for puncture and/or infiltration for gonalgia in the context of knee osteoarthritis or knee arthritis related to chronic inflammatory rheumatism.
Key inclusion criteria (5 listed)
- - Male or female
- Age ≥ 18 years
- Information and consent of the patient or of a third person in case of physical incapacity to sign the consent form
- Unilateral or bilateral symptomatic knee OA (both knees may be included at the same time or at different times) regardless of the level of pain, confirmed radiologically by X-ray dating less than one year [(Kellgren and Lawrence score ≥2 in at least one of the 3 compartments (medial, lateral or patellofemoral)] or arthritis of the knee related to a spondyloarthritis or rheumatoid arthritis
- Registered at the social security system
Key exclusion criteria (5 listed)
- Male or female
- Age ≥ 18 years
- Information and consent of the patient or of a third person in case of physical incapacity to sign the consent form
- Unilateral or bilateral symptomatic knee OA (both knees may be included at the same time or at different times) regardless of the level of pain, confirmed radiologically by X-ray dating less than one year [(Kellgren and Lawrence score ≥2 in at least one of the 3 compartments (medial, lateral or patellofemoral)] or arthritis of the knee related to a spondyloarthritis or rheumatoid arthritis
- Registered at the social security system
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 |
|---|---|---|
| SA brief descriptive name used to refer to the intervention(s) studiedDetails that can be made public about the intervention | Other | patients with knee arthritis related to chronic inflammatory rheumatism, patients with knee osteoarthritis |
Primary outcome
Changes of pain on a 0-100mm VAS from baseline clinical phenotype of OA patients through study completion
Time frame: 10 years
performed at baseline, each year (annual visit) up to 10 years but also each time a new knee arthrocentesis or injection
Evaluation of the radiological phenotype
Time frame: 10 years
performed at baseline, each year (annual visit) up to 10 years but also each time a new knee arthrocentesis or injection
Changes of WOMAC score A, B, C and WOMAC total from baseline clinical phenotype of OA patients through study completion
Time frame: 10 years
performed at baseline, each year (annual visit) up to 10 years but also each time a new knee arthrocentesis or injection
Changes of Lequesne score from baseline clinical phenotype of OA patients through study completion
Time frame: 10 years
performed at baseline, each year (annual visit) up to 10 years but also each time a new knee arthrocentesis or injection
Changes of quality of life index defined by EQ5D-5L from baseline clinical phenotype of OA patients through study completion
Time frame: 10 years
performed at baseline, each year (annual visit) up to 10 years but also each time a new knee arthrocentesis or injection
Changes of KOFUS score from baseline clinical phenotype of OA patients through study completion
Time frame: 10 years
performed at baseline, each year (annual visit) up to 10 years but also each time a new knee arthrocentesis or injection
Changes of DN4 Neuropathic Pain Score from baseline clinical phenotype of OA patients through study completion
Time frame: 10 years
performed at baseline, each year (annual visit) up to 10 years but also each time a new knee arthrocentesis or injection
Obtention of an acceptable Symptom State assessed by the PASS (Patient Acceptable Symptom State) through study completion
Time frame: 10 years
performed at baseline, each year (annual visit) up to 10 years but also each time a new knee arthrocentesis or injection
Occurrence of a clinical extension of OA disease (presence of a generalized disease in case of association of knee and hand OA) through study completion
Time frame: 10 years
performed at baseline, each year (annual visit) up to 10 years but also each time a new knee arthrocentesis or injection
Worsening of radiographic lesions from baseline through study completion assessed by X-rays of the knees (frontal, lateral, Schuss and patellofemoral views) according to the Kellgren and Lawrence score
Time frame: 10 years
performed at baseline, every 2 years up to 10 years but also in case of congestive or painful flare-ups in target knee according to the Kellgren and Lawrence score
Analysis of several blood markers [cartilage degradation markers (CTXII, col2-1, col2-1No), anabolic markers (PIIANP), cytokines (IL-6 and IL-8), ultra-sensitive CRP, proteoglycans (PG), glycosaminoglycans (GAG)]
Time frame: 10 years
performed at baseline but also each time a new knee arthrocentesis or injection will be performed through study completion
Analysis of several biological markers obtained from PRP [growth factors (FGF, TGF, PDGF, VEGF, IGF,...) and GAGs]
Time frame: 10 years
performed at baseline but also each time a new knee arthrocentesis or injection will be performed through study completion
Analysis of several biological markers obtained from synovial fluid [inflammatory cytokines IL-6 and IL-8, PG, GAG, metalloproteinases (MMP)].
Time frame: 10 years
performed at baseline but also each time a new knee arthrocentesis or injection will be performed through study completion
6 secondary outcomes
Assessment of pain on a VAS 0-100mm for patients with knee OA
Time frame: 10 years
Assessment of the effusion for patients with knee OA
Time frame: 10 years
Assessment of the WOMAC score A, B, C and WOMAC total for patients with knee OA
Time frame: 10 years
Assessment of the Lequesne score for patients with knee OA
Time frame: 10 years
Assessment of the quality of life index defined by EQ5D-5L for patients with knee OA
Time frame: 10 years
Assessment of the KOFUS flare score for patients with knee OA
Time frame: 10 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 11 Feb 2026.
- Individual participant dataSharing planned: No. No DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
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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.
Florent EYMARD, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis and Chronic Inflammatory Rheumatism, 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 5 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: looking for participants now, as of the sponsor's last update on 11 Feb 2026. 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?
Contact Florent EYMARD, MD, PhD (+33149812701, florent.eymard@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of pain on a 0-100mm VAS from baseline clinical phenotype of OA patients through study completion (time frame: 10 years). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Feb 2026.