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

Knee Osteoarthritis Clinical Trial

— PRODIGE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02070224
• Other study ID #: PRODIGE
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: February 2019

Study information

• Verified date: January 2017
• Source: Artialis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• 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)
• Imaging (x-rays and MRI)
MRI will be done at baseline and 12 month and x-rays will be done at baseline

Locations

Country	Name	City	State
Belgium	University Hospital of Liege-CHU	Liege
France	University Hospital of Nancy	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Artialis

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Knee prosthesis during the study		12 month
Other	MRI cartilage volume (optional)		12 month
Other	MRI T2 relaxation time (optional)		12 month
Other	MRI MOAKS scoring (optional)		12 month
Primary	MRI will be analysed with semiquantitative Whole-Organ Magnetic Resonance Imaging Scoring method (WORMS)		12 month
Secondary	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