- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02070224
Evaluation of the Prognostic Value of Biological Markers, Coll2-1 and Coll2-1NO2 in Patients With Symptomatic Knee Osteoarthritis (PRODIGE)
February 4, 2019 updated by: Artialis
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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:
- 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).
Exclusion Criteria:
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
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Knee osteoarthritis
|
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)
MRI will be done at baseline and 12 month and x-rays will be done at baseline
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
MRI will be analysed with semiquantitative Whole-Organ Magnetic Resonance Imaging Scoring method (WORMS)
Time Frame: 12 month
|
12 month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
12 month
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Knee prosthesis during the study
Time Frame: 12 month
|
12 month
|
MRI cartilage volume (optional)
Time Frame: 12 month
|
12 month
|
MRI T2 relaxation time (optional)
Time Frame: 12 month
|
12 month
|
MRI MOAKS scoring (optional)
Time Frame: 12 month
|
12 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Hick 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Actual)
February 1, 2019
Study Completion (Actual)
February 1, 2019
Study Registration Dates
First Submitted
February 19, 2014
First Submitted That Met QC Criteria
February 24, 2014
First Posted (Estimate)
February 25, 2014
Study Record Updates
Last Update Posted (Actual)
February 5, 2019
Last Update Submitted That Met QC Criteria
February 4, 2019
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRODIGE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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