Knee OsteoarthritisMOKHANCT04293861
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®
A study testing HYMOVIS in people with Knee Osteoarthritis, run by Fidia Farmaceutici s.p.a. at 8 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- HYMOVIS
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 1 Apr 2015to 6 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 38Show fewer
- 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
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Belgium4 sites
Service de Rhumatologie, CHU Brugmann
Brussels, 1020
CHR Citadelle de Liège
Liège, 4000
Service de Rhumatologie CHU Liège
Liège, 4000
Service de Rhumatologie CHU Dinant-Godinne (Site Godinne)
Yvoir, Namur, 5530
France4 sites
Hopital Edouard Herriot (Lyon)
Lyon, 69003
Service de rhumatologie,RDC Hôpital Lariboisière
Paris, 75010
Service de Rhumatologie CHR Metz Thionville Hôpital Bel Air
Thionville, Thionville Cedex, 60327 57126
Centre Hospitalier Nord Franche-Comté
Trévenans, 10499
About this study
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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- HYMOVIS
- Keywords
- Hyaluronic acid, MRI, Biomarkers, Cartilage, pain
- Medical subject headings
- Osteoarthritis, Knee, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HYMOVISDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| HYMOVIS Arm | Experimental | 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). Receives: Device: HYMOVIS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the variation of type II collagen-specific biomarkers (Coll2-1, Coll2-1NO2 & CTX-II) after HYMOVIS® treatment versus baseline
Measure of the level of Coll2-1, Coll2-1NO2 and CTX-II biomarkers in biological fluids.
Measured: Variation of levels of biomarkers from baseline (V1) trough 1 year follow up (V8)
Secondary outcomes (5)
Variation in biomarkers related to cartilage homeostasis (synthesis/degradation balance) after HYMOVIS® treatment vs. baseline
Level of Agrec, COMP, PIIANP, MMP-3 -MPO and IL-6 biomarkers.
Measured: ariation of levels of biomarkers from baseline (V1) trough 1 year follow up (V8)
Variation in MRI markers after HYMOVIS® treatment vs. baseline
Semi-quantitative WORMS - T2 relaxation time (T2 mapping) - Cartilage parameters (volume, thickness, curvature)
Measured: trough 1 year follow up
Variation in pain and function
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)
Measured: trough 1 year follow up
Responder to treatment
Responder rate to treatment (OARSI OMERACT criteria)
Measured: trough 1 year follow up
Tolerance and satisfaction
Adverse events and drop-off - Patient satisfaction scale
Measured: trough 1 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start1 Apr 2015
- Primary completion6 Jun 2017
- Study completion6 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fidia Farmaceutici s.p.a.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04293861
- Sponsor's protocol ID
- EQC5-14-02
- Acronym
- MOKHA
- Status last verified
- Mar 2020
- First submitted
- 2 Mar 2020
- Last updated
- 6 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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®
- ClinicalTrials.gov ID
- NCT04293861
- Acronym / sponsor ID
- MOKHA / EQC5-14-02
- Conditions
- Knee Osteoarthritis
- Keywords
- Hyaluronic acid, MRI, Biomarkers, Cartilage, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Fidia Farmaceutici s.p.a.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 6 Jun 2017 (actual)
- Study completion
- 6 Jun 2017 (actual)
- First posted
- 3 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HYMOVIS Arm | Experimental | Device: HYMOVISA 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). |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- 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
Key exclusion criteria (38 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HYMOVISHYMOVIS 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. | Device | HYMOVIS Arm |
Primary outcome
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.
5 secondary outcomes
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)
Variation in MRI markers after HYMOVIS® treatment vs. baseline
Time frame: trough 1 year follow up
Variation in pain and function
Time frame: trough 1 year follow up
Responder to treatment
Time frame: trough 1 year follow up
Tolerance and satisfaction
Time frame: trough 1 year follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HYMOVIS in people with Knee Osteoarthritis, run by Fidia Farmaceutici s.p.a. at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Belgium, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2020.