Clinical trial: Treatment for Patients With Osteoarthritis (OA) of the Knee (NCT00110916)

Eligibility criteria:
Inclusion Criteria: - Diagnosed with knee OA as determined by American College of
        Rheumatology (ACR) criteria - Pain defined by a level of greater than 30 mm on a 100 mm
        Visual Analogue Scale (VAS) - No evidence of active effusion or inflammatory flare,
        confirmed by investigator - Must exhibit radiographic evidence of tibio-femoral compartment
        knee OA within 12 months of screening - Stable doses of any non-prescribed supplements
        (e.g. glucosamine or chondroitin sulphate, shark cartilage, diacerhein, soya extract) for
        at least 2 months prior to screening - Unchanged use of physical therapy, biomechanical
        devices or orthotic support within at least 2 months of screening - Subjects on
        nonsteroidal anti-inflammatory drug (NSAID) therapy must discontinue NSAIDs 3 days prior to
        baseline (Day 1) - Before any study-specific procedure is performed, the appropriate
        written informed consent for participation in the study must be obtained Exclusion
        Criteria: - Malignancy within the previous 5 years, except for basal cell or in situ cancer
        - Significant hematologic disease - Active infection or history of recurrent or chronic
        infections - Known diagnosis of HIV, hepatitis B, or hepatitis C infection - Uncontrolled
        diabetes or cardiovascular disease and hypertension - Inflammatory arthropathy including
        secondary OA - Isolated OA of the patellofemoral joint (bi or tri-compartmental involvement
        are not exclusions) - End-stage ("bone-on-bone") OA (Kellgren Lawrence score of 4) - OA of
        the hip ipsilateral to the index knee - Total white cell count less than 2.0 x 109/L and/or
        platelet count less than 100 x 109/L observed within 1 month preceding screening - Prior IA
        injection of anakinra or experimental interleukin-1 (IL-1) inhibitor therapy - Concurrent
        treatment with subcutaneous (SC) anakinra - Concurrent or recent (less than or equal to 1
        month) use of experimental therapy - Prior IA corticosteroid injection within 1 month of
        study - Prior viscosupplement therapy within 3 months of study - Contraindication(s) to IA
        injections - Subjects who are pregnant or breast-feeding, or plan to become pregnant during
        the study - Subject is not using adequate contraception - Known allergy to E coli-derived
        products - Unable to understand informed consent - Concerns regarding subject's compliance
        with the protocol procedures - Subject will not be available for follow-up assessment -
        Active substance abuse
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 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