Artrosis Osteoarthritis
Conditions
Interventions
The IMD will be injected intra-articularly in the most painful knee. The
intra-articular injection will be performed by the Investigator having
experiences in knee IA injections and trained on the d
Sponsors
KiOmed PHARMA SA
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Male or female with age >= 40 years and
Exclusion criteria
Exclusion criteria: • Related to the OA pathology and related symptoms: o Radiological K&L grade 0, I or IV from a standing knee radiograph taken less than 6 months previously. o Exclusively patellofemoral osteoarthritis where the symptoms, including pain, are principally of patellofemoral origin (Patellar syndrome). o Chondromatosis or villonodular synovitis of the knee. o Clinically-apparent knee effusion, inflammation or flare-up of the knee or abnormal synovial fluid macroscopy or volume upon arthrocentesis on the day of injection. o History of injury to the treatment knee during the 6 months before inclusion or recent trauma (=5 mg/day (in prednisone equivalent) in the last 3 months before injection. o Change in the dosage regimen of symptomatic slow-acting drugs (SYSAD) or dietary supplement, i.e., curcuma extract, chondroitin, glucosamine, diacerein or avocado-soya unsaponifiables in the last 3 months before injection. o Change in physiotherapy of the treatment knee in the last 3 months. o Anticipated need for any surgical or other invasive procedure during the trial including prosthesis in the treatment knee. o Anticipated need for any forbidden OA treatments during the trial except for rescue treatment as defined in the study protocol. o Anticoagulants: coumarin-based compounds or heparin. ;• Related to associated diseases: o Any Investigator-assessed clinically significant condition that may represent a substantial risk to the patient or may have an impact on the study assessments. o History of recurrent bacterial infection, defined as at least 3 major infections resulting in hospitalization and/or requiring intravenous antibiotic treatment within the past 2 years or history of synovial infection or infections or skin diseases in the area of the injection site. o History of symptomatic hip OA o History of autoimmune disease. o Severe, ongoing and uncontrolled diseases such as malignancy or history of malignancy, type I diabetes, liver failure, renal failure, lung/heart disease, neoplasia, malignant blood disease, tumor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: Safety of the IMD will be assessed at the different time points by recording the incidence, severity and causal relationship of (Serious) Adverse Events ([S]AEs), (Serious) Adverse Device Effects ([S]ADEs), Unanticipated Serious Adverse Device Effects (USADEs) and Device Deficiencies (DDs), in accordance with ISO 14155/MEDDEV2.7/3 definitions. All AEs and SAEs will be coded using the last version of the MedDRA. In certain circumstances, local effects are normal postoperative complications of the IA injection procedure. After each injection and at each visit, the occurrence of local effects will be assessed by the investigator with a 4-point numerical rating scale (NRS). Performance: The primary performance endpoint will be assessed as a change in pain at 3 months versus pre-injection baseline using the 5-graded Likert WOMAC pain score following a single intra articulair injection. This endpoint will be determined on the clinical data collected in the Stage 2 cohort based on a randomized controlled design. Exploratory: As part the exploratory endpoints in APROOVE, different questionnaires have been established to the patient*s satisfaction and health and well-being. Specifically the SF-12 health survey is used to measure participant's profile of functional health and well-being. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Changes from baseline in total score, pain, stiffness, and physical functioning subscales of the treatment knee as measured using the 5-graded Likert WOMAC at the different time points over 6 months. • Changes from baseline in patient*s pain and global assessment using an 11-point NRS from "very poor = 0" to "excellent = 10" at the different time points over 6 months. • Response to treatment according to Osteoarthritis Research Society International (OARSI) Standing Committee for Clinical Trials Response Criteria Initiative and the Outcome Measures in Rheumatology (OMERACT) at the different time points over 6 months. • Treatment responders with >40% improvement in pre-injection pain (WOMAC Likert) at the different time points over 6 months. • Physician* usability with the device as assessed using Likert scales at Injection Visits. | — |
Countries
Netherlands
Outcome results
None listed