ETHYL ESTERS OF IODISED FATTY ACIDS FROM POPPYSEED OIL for Knee osteoarthritis

Inclusion criteria

• {"criterion_text":"- •\tAge 40 – 90 years\n- · Previous intra-articular injection in the target knee\n- •\tDiagnosis of primary KOA according to the classification of the American College of Rheumatology (ACR) (4)\n- •\tRadiographic Kellgren and Lawrence score ≥ 2 (5)\n- •\tVAS pain score ≥ 40 mm (scale 0-100 mm)\n- •\tPatient not eligible to knee surgery\n- •\tFor woman of childbearing potential: negative bêta-HCG before randomization\n- •\tSocial security affiliation\n- •\tSigned informed consent\n- •\tGood understanding of the French language"}

Exclusion criteria

• {"criterion_text":"- •\tIntra-articular injection of any product in the target joint within 3 months before embolization\n- •\tPatient unable or unwilling to comply with the follow-up schedule (at the investigator's discretion)\n- •\tVulnerable populations (such as pregnant or breastfeeding women, patient under guardianship curatorship, deprived of liberty)\n- •\tPatient under exclusion period in another trial\n- •\tPatient on AME (state medical aid)\n- •\tPrior ipsilateral partial or total knee replacement\n- •\tAny inflammatory joint disease other than osteoarthritis\n- •\tAny contra-indication to puncture of the femoral artery\n- •\tCurrent treatment with cyclosporine, tacrolimus, cisplatine, vancomycine, amphotericine B or any aminoside\n- •\tRegular intake of painkillers (except topical administration) for a pathology other than osteoarthritis\n- •\tIpsilateral symptomatic hip OA\n- •\tTreated hyperthyroidism\n- •\tKnown severe allergy to Lipiodol® and/or iodine contrast medium\n- •\tKnown moderate to severe kidney failure (creatinine clearance < 45 ml/min)\n- · Known right-to-left cardiac shunt or intra-tumoral vascular shunt\n- · Asthma attack in the 8 days before randomization\n- · Exploration or treatment with radioactive iodine scheduled within 1 month after randomization\n- · Symptomatic atheromatous lesion in the ipsilateral limb"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint is the change of the Visual Analogue Scale (VAS) pain score between randomization and 3 months (0–100 mm: 0 = No Pain, 100 = Worst Possible Pain).","definition_or_measurement_approach":"Change in VAS pain score from randomization to 3 months measured on a 0–100 mm visual analogue scale (0 = No Pain, 100 = Worst Possible Pain)."}

Secondary endpoints

• {"endpoint_text":"- •\tChange of the VAS pain score at 1, 6 and 12 months after randomization","definition_or_measurement_approach":"Change in knee VAS pain score measured at 1, 6 and 12 months after randomization using a 0–100 mm visual analogue scale."}
• {"endpoint_text":"- •\tChange of the patient’s global assessment of her/his health measured by the VAS of EQ-5D questionnaire at 1, 3, 6 and 12 months after randomization","definition_or_measurement_approach":"Patient global health assessed by the EQ-5D VAS at 1, 3, 6 and 12 months after randomization."}
• {"endpoint_text":"- •\tChange of the Western Ontario and McMaster Universities Arthritis Index (WOMAC) total score and sub-scores (pain, function, stiffness) at 1, 3, 6 and 12 months after randomization","definition_or_measurement_approach":"WOMAC total and sub-scores measured at 1, 3, 6 and 12 months after randomization."}
• {"endpoint_text":"- •\tChange of the Knee injury and Osteoarthritis Outcome Score (KOOS) total and sub-scores (knee pain, function, symptoms, sport, quality of life and stiffness) at D0 and 3 months after randomization","definition_or_measurement_approach":"KOOS total and sub-scores measured at baseline (D0) and 3 months after randomization."}
• {"endpoint_text":"- •\tChange of the Hospital Anxiety and Depression (HAD) scale total score and sub-scores (anxiety and depression) at D0 and 3 months after randomization","definition_or_measurement_approach":"HAD scale total and sub-scores measured at baseline (D0) and 3 months after randomization."}
• {"endpoint_text":"- •\tChange in semi-quantitative MRI scoring (Whole-Organ Magnetic Resonance Imaging Score [WORMS], Knee Osteoarthritis Scoring System [KOSS], Boston-Leeds Osteoarthritis Knee Scoring [BLOKS], MRI Osteoarthritis Knee Score [MOAKS]) (3) of the knee at 6 months after randomization","definition_or_measurement_approach":"Semi-quantitative MRI assessments (WORMS, KOSS, BLOKS, MOAKS) of the target knee at 6 months after randomization."}
• {"endpoint_text":"- •\tDescription of pain medication at 1, 3, 6 and 12 months","definition_or_measurement_approach":"Recording and description of pain medication use at 1, 3, 6 and 12 months after randomization."}
• {"endpoint_text":"- •\tDescription of non-pharmacological treatments at 1, 3, 6 and 12 months","definition_or_measurement_approach":"Recording and description of non-pharmacological treatments at 1, 3, 6 and 12 months after randomization."}
• {"endpoint_text":"- •\tNumber of responder patients under OMERACT-OARSI definition (1) in both groups at 3, 6 and 12 months.","definition_or_measurement_approach":"Number of responders according to OMERACT-OARSI responder criteria at 3, 6 and 12 months."}
• {"endpoint_text":"- •\tNumber of patients reaching an acceptable symptom state at 3, 6 and 12 months.","definition_or_measurement_approach":"Number of patients achieving PASS (patient acceptable symptom state) at 3, 6 and 12 months."}
• {"endpoint_text":"- •\tNumber and description of AE/SAE at 1, 3, 6 and 12 months","definition_or_measurement_approach":"Recording and description of adverse events and serious adverse events at 1, 3, 6 and 12 months."}
• {"endpoint_text":"- •\tNumber of events in the target knee including intra-articular injection, GAE, knee surgery at 6 and 12 months","definition_or_measurement_approach":"Counting and description of target knee events (intra-articular injections, GAE, knee surgery) at 6 and 12 months."}
• {"endpoint_text":"- •\tMedico-economic study: incremental cost-utility ratio","definition_or_measurement_approach":"Health economic analysis measuring incremental cost-utility ratio (details in protocol)."}
• {"endpoint_text":"- •\tChange of patient’s 3-item priority function McMaster-Toronto Arthritis Patient Preference Disability Questionnaire (MACTAR) global score at D0 and 3 months after randomization.","definition_or_measurement_approach":"MACTAR 3-item global score measured at baseline (D0) and 3 months after randomization."}
• {"endpoint_text":"- • The following baseline characteristics will be considered as potential predictors of the 3‑month OMERACT–OARSI response: age, sex, Kellgren and Lawrence score, body mass index (BMI), VAS pain score, and the semi‑quantitative MRI assessments.","definition_or_measurement_approach":"Baseline characteristics (age, sex, KL score, BMI, VAS pain, MRI assessments) evaluated as predictors of 3-month OMERACT–OARSI response."}

France

Earliest CTIS Part Ii Submission Date

17-04-2024

Latest Decision Or Authorization Date

12-05-2026

Processing Time Days

755

Number Of Sites

5

Number Of Participants

130

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France