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.
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
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
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.
Service de Rhumatologie CHU Dinant-Godinne (Site Godinne)
Yvoir, Namur, Belgium
Service de Rhumatologie, CHU Brugmann
Brussels, Belgium
CHR Citadelle de Liège
Liège, Belgium
Service de Rhumatologie CHU Liège
Liège, Belgium
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.
Time frame: Variation of levels of biomarkers from baseline (V1) trough 1 year follow up (V8)
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.
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
Semi-quantitative WORMS - T2 relaxation time (T2 mapping) - Cartilage parameters (volume, thickness, curvature)
Time frame: 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)
Time frame: trough 1 year follow up
Responder to treatment
Responder rate to treatment (OARSI OMERACT criteria)
Time frame: trough 1 year follow up
Tolerance and satisfaction
Adverse events and drop-off - Patient satisfaction scale
Time frame: trough 1 year follow up
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Service de Rhumatologie CHR Metz Thionville Hôpital Bel Air
Thionville, Thionville Cedex, France
Hopital Edouard Herriot (Lyon)
Lyon, France
Service de rhumatologie,RDC Hôpital Lariboisière
Paris, France
Centre Hospitalier Nord Franche-Comté
Trévenans, France