Evaluation of the Prognostic Value of Biological Markers, Coll2-1 and Coll2-1NO2 in Patients With Symptomatic Knee Osteoarthritis
PRODIGE
1 other identifier
interventional
120
2 countries
2
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable knee-osteoarthritis
Started Jan 2014
Longer than P75 for not_applicable knee-osteoarthritis
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 19, 2014
CompletedFirst Posted
Study publicly available on registry
February 25, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2019
CompletedFebruary 5, 2019
January 1, 2017
5.1 years
February 19, 2014
February 4, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
MRI will be analysed with semiquantitative Whole-Organ Magnetic Resonance Imaging Scoring method (WORMS)
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
12 month
Other Outcomes (4)
Knee prosthesis during the study
12 month
MRI cartilage volume (optional)
12 month
MRI T2 relaxation time (optional)
12 month
- +1 more other outcomes
Study Arms (1)
Knee osteoarthritis
OTHERInterventions
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
Eligibility Criteria
You may qualify if:
- 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
- +4 more criteria
You may not qualify if:
- 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 are the subject of a judicial protection measure or under guardianship
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Artialislead
Study Sites (2)
University Hospital of Liege-CHU
Liège, 4000, Belgium
University Hospital of Nancy
Nancy, France
Related Publications (2)
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.
PMID: 34128409DERIVEDHick 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.
PMID: 31631693DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2014
First Posted
February 25, 2014
Study Start
January 1, 2014
Primary Completion
February 1, 2019
Study Completion
February 1, 2019
Last Updated
February 5, 2019
Record last verified: 2017-01