Evaluation of the Prognostic Value of Biological Markers, Coll2-1 and Coll2-1NO2 in Patients With Symptomatic Knee Osteoarthritis

NCT ID: NCT02070224

Last Updated: 2019-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2019-02-28

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Knee osteoarthritis

Group Type: OTHER

Serum and urine samples collections

Intervention Type: OTHER

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)

Intervention Type: OTHER

MRI will be done at baseline and 12 month and x-rays will be done at baseline

Interventions

Serum and urine samples collections

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)

Intervention Type: OTHER

Imaging (x-rays and MRI)

MRI will be done at baseline and 12 month and x-rays will be done at baseline

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Artialis

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital of Liege-CHU

Liège, , Belgium

University Hospital of Nancy

Nancy, , France

Countries

Belgium; France

References

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.

Reference Type: DERIVED

PMID: 34128409 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31631693 (View on PubMed)

Other Identifiers

PRODIGE

Identifier Type: -

Identifier Source: org_study_id