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.

Study Locations

  • Belgium
      • Liege, Belgium, 4000
        • University Hospital of Liege-CHU
  • France
      • Nancy, France
        • University Hospital of Nancy

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
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)
Other: Imaging (x-rays and MRI)
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

Artialis

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

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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