Knee osteoarthritis Musculoskeletal Diseases Osteoarthritis
Conditions
Interventions
1. Each patient will be enrolled in the study for 13 months (nine visits)
2. Patients will receive two treatment cycles of Hymovis® at 6 month intervals
each treatment cycle corresponds to two intra-articular injections at 1 week intervals
Sponsors
Fidia Farmaceutici Spa
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 40–75 years old 2. Monolateral (unless contralateral knee is grade I and asymptomatic) femorotibial knee osteoarthritis associated or not with femoropatellar knee osteoarthritis 3. Clinical and radiological criteria of the American College of Rheumatology 4. Symptomatic for more than 6 months in the most painful knee 5. Radiological Kellgren and Lawrence grade II or III in radiographs from less than 12 months ago 6. Mean knee pain score of the most painful knee at rest over the past 24 hours on the Visual Analogue Scale (0–100) of at least 40 with a washout period for Paracetamol and oral non-steroidal anti-inflammatory drugs depending on the half-life of the drug 7. Able to follow the instructions of the study 8. Signed an informed consent form
Exclusion criteria
Exclusion criteria: 1. Bilateral (except asymptomatic and grade I) osteoarthritis of the knee 2. Radiological Kellgren and Lawrence grade I or IV 3. Chondromatosis or villonodular synovitis of the knee 4. Recent trauma (<1 month) of the symptomatic knee 5. Acute inflammatory osteoarthritis 6. Articular disease resulting from articular dysplasia, aseptic osteonecrosis, acromegaly, Paget’s disease, haemophilia or haemochromatosis 7. Inflammatory disease 8. Pathologies interfering with the evaluation of osteoarthritis 9. Contraindications to Hymovis®: hypersensitivity to the product components and infections or skin diseases in the area of the injection site 10. Anticoagulants (coumarinic compounds) and heparin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Variation in type II collagen-specific biomarkers: levels will be measured at screening visit, follow-up visits after 1 month and 3 months, and last visit after 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Variation in biomarkers related to cartilage homoeostasis: levels of biomarkers will be measured at the screening visit, follow-up visits after 1 month and 3 months, and at the last visit after 12 months 2. Variation in magnetic resonance imaging (MRI) markers: measured at the screening visit and after 12 months 3. Variation in pain and function: measured with the visual analogue scale at the screening visit, follow-up visits after 1 month and 3 months, and at the last visit after 12 months 4. Response to treatment: measured with the OMERACT–OARSI (Outcome Measures in Rheumatology–Osteoarthritis Research Society International) set of responder criteria at the screening visit, follow-up visits after 1 month and 3 months, and last visit after 12 months 5. Tolerance and satisfaction: measured with adverse events and drop-off rates at the screening visit, follow-up visits after 1 month and 3 months, and end visit after 12 months | — |
Countries
Belgium, France
Contacts
Public ContactMichel Malaise
Outcome results
None listed