Knee OsteoarthritisPRODIGENCT02070224
Evaluation of the Prognostic Value of Biological Markers, Coll2-1 and Coll2-1NO2 in Patients With Symptomatic Knee Osteoarthritis
A study testing Serum and urine samples collections and Imaging (x-rays and MRI) in people with Knee Osteoarthritis, run by Artialis at 2 sites in 2 countries.
Trial summary
The purposes of this study are to assess the prognostic value of serum and urinary biomarkers Coll2-1 and Coll2-1NO2 at baseline, and their change over the first year, on the progression of knee osteoarthritis MRI scores at 12 months, on the progression of knee osteoarthritis clinical score at 12 months. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Serum and urine samples collections and Imaging (x-rays and MRI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2014to Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged 45 to 80 years with a BMI ≤ 40
- With an uni- or bilateral femorotibial knee osteoarthritis associated or not with a femoro-patellar knee osteoarthritis
- Responding to clinical and radiological criteria of the ACR
- Symptomatic for more than 6 months (for the most painful knee)
- K\&L radiological grade of Felson II or III
- With a cartilage lesion identified during MRI and either at least 1 out of 4 MRI severity criteria:
Show all 19Show fewer
- bone oedema
- meniscal lesion in the central region of the medial compartment
- effusion without answer to corticosteroids
- zone without cartilage
- or at least 1 out of 3 clinical severity criteria:
- genu varum>3°
- previous meniscal surgery
- known polyarthritis
- effusion on the target knee
- Sign an informed consent after being informed
- Able to follow the instructions of the study
- With an agreement from the physicians having established the diagnosis of osteoarthritis (if any) to give relevant information to the investigator
- With health insurance (for France).
Who cannot join
- For osteoarthritis:
- Isolated patellofemoral arthritis
- Chondromatosis or villo-nodular synovioma of the knee
- Recent trauma-induced knee pain
- Joint disease due to joint dysplasia, aseptic osteonecrosis, acromegaly, Paget's disease, hemophilia, hemochromatosis, …
- inflammatory pathologies as rheumatoid polyarthritis, gout arthritis, infectious arthritis
Show all 21Show fewer
- Diseases that may interfere with the evaluation of osteoarthritis (radiculalgia of lower limbs, arteritis, …)
- Genu valgum (degree considered as pathological by the physician)
- For previous treatments:
- Treatment with strontium ranelate, bisphosphonates, SERM and PTH
- For known associated diseases:
- Serious associated diseases: severe liver or renal failure, uncontrolled cardiovascular disease, HIV, hepatitis B or C
- Knee tumor
- For patients:
- Patient who participated to a therapeutic clinical trial 3 months before the T0 inclusion visit
- Patient who are the subject of a judicial protection measure or under guardianship
- Pregnant woman
- For MRI contraindications:
- Patient with a pacemaker, an implantable defibrillator, neurosurgical clips, a neurostimulator, cochlear implant, a stent, an insulin pump
- Patient with a ferromagnetic splinter in the body, or having wire sutures
- Serious mobility problem (Parkinson, tremors)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
The purposes of this study are to assess the prognostic value of serum and urinary biomarkers Coll2-1 and Coll2-1NO2 at baseline, and their change over the first year, on the progression of knee osteoarthritis MRI scores at 12 months, on the progression of knee osteoarthritis clinical score at 12 months. Additionally, this study will search for correlations between serum and urinary biomarkers Coll2-1 and Coll2-1NO2 at baseline with the radiographic, MRI and clinical severity of knee osteoarthritis.
- Conditions
- Knee Osteoarthritis
- Being tested
- Serum and urine samples collections, Imaging (x-rays and MRI)
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum and urine samples collectionsOther
Serum and urine samples will be collected at baseline, 3 month, 6 month, 12 month to assess the predictive value of cartilage-specific biomarkers Coll2-1/Coll2-1NO2 on OA progression (MRI, Clinical and radiological progression)
Imaging (x-rays and MRI)Other
MRI will be done at baseline and 12 month and x-rays will be done at baseline
| Study group | Role | What they receive |
|---|---|---|
| Knee osteoarthritis | Other | Not described Receives: Other: Serum and urine samples collections; Other: Imaging (x-rays and MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI will be analysed with semiquantitative Whole-Organ Magnetic Resonance Imaging Scoring method (WORMS)
Measured: 12 month
Secondary outcomes (1)
Knee injury and Osteoarthritis Outcome Score (KOOS) and Visual Analogue Scales (VAS) for mean knee pain and global patient assessment of disease activity
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionFeb 2019
- Study completionFeb 2019
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 Knee OsteoarthritisStudies of the same condition, open and under way.
- 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Artialis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02070224
- Sponsor's protocol ID
- PRODIGE
- Acronym
- PRODIGE
- Status last verified
- Jan 2017
- First submitted
- 19 Feb 2014
- Last updated
- 5 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hick AC, Malaise M, Loeuille D, Conrozier T, Maugars Y, Pelousse F, Tits C, Henrotin Y. Cartilage Biomarkers Coll2-1 and Coll2-1NO2 Are Associated with Knee OA MRI Features and Are Helpful in Identifying Patients at Risk of Disease Worsening. Cartilage. 2021 Dec;13(1_suppl):1637S-1647S. doi: 10.1177/19476035211021892. Epub 2021 Jun 15.
PubMed 34128409Hick AC, Fonck M, Costes B, Cobraiville E, Pirson S, Garcia L, Labasse A, Vander Poelen S, Henrotin Y. Serum Levels of Coll2-1, a Specific Biomarker of Cartilage Degradation, Are Not Affected by Sampling Conditions, Circadian Rhythm, and Seasonality. Cartilage. 2021 Dec;13(1_suppl):540S-549S. doi: 10.1177/1947603519878489. Epub 2019 Oct 20.
PubMed 31631693
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Prognostic Value of Biological Markers, Coll2-1 and Coll2-1NO2 in Patients With Symptomatic Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT02070224
- Acronym / sponsor ID
- PRODIGE / PRODIGE
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- ArtialisIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Feb 2019 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 25 Feb 2014 (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.
The purposes of this study are to assess the prognostic value of serum and urinary biomarkers Coll2-1 and Coll2-1NO2 at baseline, and their change over the first year, on the progression of knee osteoarthritis MRI scores at 12 months, on the progression of knee osteoarthritis clinical score at 12 months. Additionally, this study will search for correlations between serum and urinary biomarkers Coll2-1 and Coll2-1NO2 at baseline with the radiographic, MRI and clinical severity of knee osteoarthritis.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Knee osteoarthritis | Other | Other: Serum and urine samples collections, Other: Imaging (x-rays and MRI) |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Male or female, aged 45 to 80 years with a BMI ≤ 40
- With an uni- or bilateral femorotibial knee osteoarthritis associated or not with a femoro-patellar knee osteoarthritis
- Responding to clinical and radiological criteria of the ACR
- Symptomatic for more than 6 months (for the most painful knee)
- K\&L radiological grade of Felson II or III
Key exclusion criteria (21 listed)
- Isolated patellofemoral arthritis
- Chondromatosis or villo-nodular synovioma of the knee
- Recent trauma-induced knee pain
- Joint disease due to joint dysplasia, aseptic osteonecrosis, acromegaly, Paget's disease, hemophilia, hemochromatosis, …
- inflammatory pathologies as rheumatoid polyarthritis, gout arthritis, infectious arthritis
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 |
|---|---|---|
| Serum and urine samples collectionsSerum and urine samples will be collected at baseline, 3 month, 6 month, 12 month to assess the predictive value of cartilage-specific biomarkers Coll2-1/Coll2-1NO2 on OA progression (MRI, Clinical and radiological progression) | Other | Knee osteoarthritis |
| Imaging (x-rays and MRI)MRI will be done at baseline and 12 month and x-rays will be done at baseline | Other | Knee osteoarthritis |
Primary outcome
MRI will be analysed with semiquantitative Whole-Organ Magnetic Resonance Imaging Scoring method (WORMS)
Time frame: 12 month
1 secondary outcome
Knee injury and Osteoarthritis Outcome Score (KOOS) and Visual Analogue Scales (VAS) for mean knee pain and global patient assessment of disease activity
Time frame: 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
- Derived from this study: PubMed 34128409Hick AC, Malaise M, Loeuille D, Conrozier T, Maugars Y, Pelousse F, Tits C, Henrotin Y. Cartilage Biomarkers Coll2-1 and Coll2-1NO2 Are Associated with Knee OA MRI Features and Are Helpful in Identifying Patients at Risk of Disease Worsening. Cartilage. 2021 Dec;13(1_suppl):1637S-1647S. doi: 10.1177/19476035211021892. Epub 2021 Jun 15.
- Derived from this study: PubMed 31631693Hick AC, Fonck M, Costes B, Cobraiville E, Pirson S, Garcia L, Labasse A, Vander Poelen S, Henrotin Y. Serum Levels of Coll2-1, a Specific Biomarker of Cartilage Degradation, Are Not Affected by Sampling Conditions, Circadian Rhythm, and Seasonality. Cartilage. 2021 Dec;13(1_suppl):540S-549S. doi: 10.1177/1947603519878489. Epub 2019 Oct 20.
Related trials for Knee Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serum and urine samples collections and Imaging (x-rays and MRI) in people with Knee Osteoarthritis, run by Artialis at 2 sites in 2 countries.
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 19 inclusion and 21 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: finished, as of the sponsor's last update on 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
MRI will be analysed with semiquantitative Whole-Organ Magnetic Resonance Imaging Scoring method (WORMS) (time frame: 12 month). 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 NCT02070224, 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 5 Feb 2019.