Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2025-12-24 @ 5:55 PM
NCT ID:
NCT02821468
Eligibility Criteria:
Inclusion Criteria:
* Femorotibial knee OA (Uni- or bilateral)
* Responding to clinical and radiological criteria of American College of Rheumatology (ACR)
* Symptomatic for more than 6 months in the most painful knee
* Radiological K\&L grade II-III in radiographs from less than 12 months
* Moderate-to-severe knee pain: knee pain score evaluated on Visual Analogue Scale (VAS) (0-100) ≥ 40 over the last 24 hours at the inclusion visit (the most painful knee is considered)
* Able to follow the instructions of the study
* Having signed an informed consent
Exclusion Criteria:
Related to the OA pathology
* Recent trauma (\< 1 month) of the knee responsible of the symptomatic knee
* Concurrent articular disease interfering with the evaluation of OA and/or pain such as articular dysplasia, aseptic osteonecrosis, acromegaly, Paget's disease, hemophilia, hemochromatosis, chondromatosis, villonodular synovitis of the knee, seronegative spondyloarthropathy, rheumatoid arthritis, gouty arthritis , infectious arthritis, radiculalgia in the lower limbs, arteritis, etc.
* Radiological K\&L grade I or IV
* Prosthesis in the target knee
Related to treatments
* Analgesics to manage OA knee pain 24h before inclusion visit
* Corticosteroids injection in the target knee in the month preceding inclusion
* Hyaluronan injection in the target knee in the last 6 months
* Oral corticotherapy ≥ 5mg/day in the last 3 months
* Symptomatic slow-acting drugs (SYSADs) treatment (Chondroitin, diacerein, glucosamine, soy and avocado unsaponifiables) in the last 3 months
* An anticipated need for any OA related medication for the duration of the trial (Corticosteroids or hyaluronan injection, Oral corticotherapy, Arthroscopy, analgesics other than the authorized rescue treatments) which are forbidden during the trial
* Arthroscopy in the last 6 months
* Patients with known allergy to CS, GH, or intolerance to rescue treatment (Paracetamol and NSAIDs)
* Patients with allergy to shellfish
Related to associated diseases
* Severe and uncontrolled diseases (liver or renal failure, lung/heart severe disease, tumor, HIV….)
* Anticipated need for any surgical or other invasive procedure during the trial including prosthesis in the target knee Related to patients
* Artialis (study coordinator) or Bioiberica (Sponsor) 's employees
* Participation to a therapeutic clinical trial in the last 3 months
* Under guardianship or judicial protection
* Pregnancy, breastfeeding, planned conception
* Women without menopause or tubal ligation and without contraception
Related to MRI
* Unable to receive gadopentetate contrast agent injection because of contraindications:
* Acute or chronic severe renal insufficiency (a glomerular filtration rate \< 30 mL/min/1.73m2); or
* Acute renal insufficiency of any severity due to the hepato-renal syndrome or in the peri-operative liver transplantation period.
* Known anaphylactic reactions to Gadolinium or related substances
* Risk groups for MRI scanning due to magnetic field or contrast agent: Metal in body: Pacemaker / Automatic Implantable Cardioverter Defibrillators / Implantable Cardioverter Defibrillators (coronary defibrillator), Nervus vagus stimulator, Artificial heart valve (depending on type), Metal clips on cerebral arteries or veins, Metal particles in eye, Port-a-cath, Metal stents, Hydrocephalic pump / insulin pump, Metal implants; f/e screws, prostheses, piercings.
* Claustrophobia, or serious mobility problem (Parkinson, tremors)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT02821468
Study Brief:
Protocol Section:
NCT02821468