Evaluation of the Evolution of Biological and Imaging Markers of Bone and Cartilage Degradation in Patients With Knee Osteoarthritis Receiving Intra-articular Injections of a Hyaluronan Derivative HYMOVIS® (MOKHA)

March 4, 2020 updated by: Fidia Farmaceutici s.p.a.
This pilot study MOKHA is aimed to evaluate the beneficial effect of HYMOVIS® on cartilage of patients suffering of knee osteoarthritis as revealed by using scientifically sound, objective measurements of biological and MRI-based imaging markers.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is a post-marketing, open-label, prospective and multicentric pilot study in 50 patients suffering from knee OA. Investigators will be rheumatologists or articular disease specialists from public or academic hospitals located in Belgium and France. In each investigating center, the same injector will perform all the VS.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
      • Bruxelles, Belgium, 1020
        • Service de Rhumatologie, CHU Brugmann
      • Liège, Belgium, 4000
        • CHR Citadelle de Liège
      • Liège, Belgium, 4000
        • Service de Rhumatologie CHU Liège
    • Namur
      • Yvoir, Namur, Belgium, 5530
        • Service de Rhumatologie CHU Dinant-Godinne (Site Godinne)
  • France
      • Lyon, France, 69003
        • Hopital Edouard Herriot (Lyon)
      • Paris, France, 75010
        • Service de rhumatologie,RDC Hôpital Lariboisière
      • Trévenans, France, 10499
        • Centre Hospitalier Nord Franche-Comté
    • Thionville Cedex
      • Thionville, Thionville Cedex, France, 60327 57126
        • Service de Rhumatologie CHR Metz Thionville Hôpital Bel Air

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female between the age of 40 and 80 with BMI ≤ 40

  • Monolateral (unless contralateral knee is grade I and asymptomatic) femorotibial knee OA associated or not with femoropatellar knee OA

    • Responding to clinical and radiological criteria of the American College of Rheumatology (ACR) (Appendix 1)
    • Symptomatic for more than 6 months in the most painful knee
    • Radiological Kellgren & Lawrence (K&L) II or III in radiographs from less than 12 months (Appendix 2)
  • Mean knee pain score at rest over the last 24 hours evaluated on VAS (0-100) ≥ 40 (Appendix 3) with a washout period for Paracetamol and oral NSAIDs depending on the half-life of the drug (Appendix 4). The most painful knee is considered.
  • Able to follow the instructions of the study
  • Having signed an ICF

Exclusion Criteria:

Related to the OA pathology

  • Bilateral (except asymptomatic and grade I) OA of the knee
  • Radiological K&L grade I or IV (Appendix 2)
  • Chondromatosis or villonodular synovitis of the knee
  • Recent trauma (< 1 month) of the knee responsible of the symptomatic knee
  • Acute inflammatory OA (KOFUS (Knee Osteoarthritis Flare Up Scale) score ≥ 7, Appendix 5)
  • Articular disease resulting from articular dysplasia, aseptic osteonecrosis, acromegaly, Paget's disease, hemophilia, hemochromatosis….
  • Inflammatory disease i.e. rheumatoid arthritis, gout, infectious arthritis, acute calcium pyrophosphate arthritis
  • Pathologies interfering with the evaluation of OA (radiculalgia in the lower limbs, arteritis…..)
  • Presence of another joint (other than the target knee) affected by OA (confirmed in radiographs and symptomatic)

Related to treatments

  • Corticosteroids injection in the target knee in the last month before first injection
  • Hyaluronan injection in the target knee in the last 6 months before first injection
  • Arthroscopy and surgery in the target knee in the last 6 months before first injection
  • Oral corticotherapy ≥ 5mg/day (in Prednisone equivalent) in the last 3 months before first injection
  • OA treatments based on curcuma extract (e.g. FLEXOFYTOL) in the last 3 months before first injection
  • Change in the dosage of SYSAD i.e. chondroitin, glucosamine, diacerein or avocado-soy unsaponifiables in the last 3 months before first injection
  • Paracetamol and oral NSAIDs before inclusion and follow-up visits (washout period depending on the half-life of the drug, Appendix 4).
  • Osteoporosis-related treatments based on strontium ranelate, selective estrogen-receptor modulator (SERM) and parathormone (PTH) in the last 12 months before first injection
  • An anticipated need for any forbidden OA treatments during the trial
  • Contraindications to HYMOVIS®: hypersensitivity to the product components and infections or skin diseases in the area of the injection site.
  • Non-pharmacologic therapy (including physical therapy) for the lower extremities initiated in the month before first injection
  • Anticoagulant (coumarinic compound) and heparin

Related to associated diseases

  • Severe diseases (liver or renal failure, lung/heart disease, tumor, HIV….)
  • Allergy or contra-indication to hyaluronan
  • Severe alteration of mobility enabling functional evaluation
  • High risk of hemorrhage and risk of infection at the site of injection
  • Anticipated need for any surgical or other invasive procedure during the trial including prosthesis in the target knee

Related to patients

  • Participation to a therapeutic clinical trial in the last 3 months before first injection
  • Under guardianship or judicial protection
  • Pregnancy, breastfeeding, planned conception, premenopausal women without contraception, tubal ligation or hysterectomy

Related to MRI counter-indication

  • Patient with a pacemaker, an implantable defibrillator, neurosurgical clips, a neurostimulator, cochlear implant, a stent from less than 3 weeks, an insulin pump
  • Patient with a ferromagnetic splinter in the body, or having wire sutures
  • Serious mobility problem (Parkinson, tremors),
  • Claustrophobia

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: HYMOVIS Arm
A treatment cycle consists of two injections administered at one week interval. For the purpose of this study, two treatment cycles of two injections of HYMOVIS® at baseline and 6 months will be performed per patient at V1 (Day 0), V2 (Day 7), V5 (Day 180) and V6 (Day 187).
Device: HYMOVIS
HYMOVIS is a clear hydrogel obtained by hydration of the HA-based derivative named HYADD4p5. The conjugate compound is constituted by a partial hexadecylamide of hyaluronic acid, which is produced by a fermentation process.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Assess the variation of type II collagen-specific biomarkers (Coll2-1, Coll2-1NO2 & CTX-II) after HYMOVIS® treatment versus baseline
Time Frame: Variation of levels of biomarkers from baseline (V1) trough 1 year follow up (V8)
Measure of the level of Coll2-1, Coll2-1NO2 and CTX-II biomarkers in biological fluids.
Variation of levels of biomarkers from baseline (V1) trough 1 year follow up (V8)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Variation in biomarkers related to cartilage homeostasis (synthesis/degradation balance) after HYMOVIS® treatment vs. baseline
Time Frame: ariation of levels of biomarkers from baseline (V1) trough 1 year follow up (V8)
Level of Agrec, COMP, PIIANP, MMP-3 -MPO and IL-6 biomarkers.
ariation of levels of biomarkers from baseline (V1) trough 1 year follow up (V8)
Variation in MRI markers after HYMOVIS® treatment vs. baseline
Time Frame: trough 1 year follow up
Semi-quantitative WORMS - T2 relaxation time (T2 mapping) - Cartilage parameters (volume, thickness, curvature)
trough 1 year follow up
Variation in pain and function
Time Frame: trough 1 year follow up
Pain and function evaluated with KOOS index - VAS for the mean knee pain over the last 24 hours at rest and while walking pain - VAS for global assessment of disease activity (by patient and by investigator)
trough 1 year follow up
Responder to treatment
Time Frame: trough 1 year follow up
Responder rate to treatment (OARSI OMERACT criteria)
trough 1 year follow up
Tolerance and satisfaction
Time Frame: trough 1 year follow up
Adverse events and drop-off - Patient satisfaction scale
trough 1 year follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fidia Farmaceutici s.p.a.

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 6, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 6, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 2, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 3, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 6, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EQC5-14-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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