Clinical trial: Evaluation of the Evolution of Imaging Markers of Cartilage Degradation in Patients With Knee Osteoarthritis Receiving DROGLICAN (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)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.


Patient description (medical language): A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee.

Patient description (patient's own words): I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee.

Does the patient match the trial criteria? Entailment