Clinical trial: To Determine the Safety, Tolerability, Pharmacokinetics and Effect on Pain of a Single Intra-articular Administration of Canakinumab in Patients With Osteoarthritis in the Knee (NCT01160822)

Eligibility criteria:
Inclusion Criteria:

          1. Written informed consent must be obtained before any assessment is performed.

          2. Male and female patients aged 40 - 80 years (inclusive).

          3. Diagnosis of knee osteoarthritis

          4. Radiographic evidence of tibiofemoral compartment osteoarthritis

          5. Pain in the knee during the last 24 hours.The patients should also have had pain in
             the affected knee on most days over the last month.

          6. Patients who are willing to discontinue all non-steroidal anti-inflammatory drugs
             (NSAIDs) or other analgesic medication taken for any condition, including their knee
             pain,

          7. Patients who are on stable dose of opioids for at least 1 month before screening can
             continue to take their opioid at this stable dose throughout the study.

          8. Patients must also be willing to abstain from any intra-articular or peri-articular
             injections to the knee or surgery during the treatment period

          9. Patients who, if they are currently taking aspirin (325 mg/day or less; as
             anti-coagulants), are willing to remain on a stable dose one month prior to screening
             and throughout the study

        Exclusion Criteria:

          1. Subjects with known hypersensitivity to any biological or investigational drugs.

          2. Patients with contraindications to knee injections

          3. Patients with joint effusion

          4. Patients should not have rheumatoid arthritis or any connective tissue like disease

          5. Secondary osteoarthritis with history and/or any evidence of the following diseases:
             septic arthritis, inflammatory joint disease, gout, Paget's disease of the bone,
             articular fracture, major dysplasias or congenital abnormality, ochronosis,
             acromegaly, hemochromatosis, Wilson's disease, primary osteochondromatosis, juvenile
             chronic arthritis with continued activity in adulthood, heritable disorders (e.g.
             hypermobility). Patients with secondary osteoarthritis following menisectomy or
             injuries of a collateral or cruciate ligament are not excluded.

          6. Presence or history of underlying metabolic, endocrine, hematologic, pulmonary,
             cardiac, blood, renal, hepatic, infectious, psychiatric or gastrointestinal conditions

          7. Evidence of tuberculosis (TB)

          8. One of the risk factors for TB such as:

               1. Substance abuse (e.g. injection or non-injection)

               2. Health-care workers with unprotected exposure to patients who are at high risk of
                  TB

               3. Patients with TB disease before the identification and correct airborne
                  precautions of the patient

               4. close contact (i.e. share the same air space in a household or other enclosed
                  environment for a prolonged period (days or weeks, not minutes or hours)) with a
                  person with active pulmonary TB disease.

          9. Significant medical problems, including but not limited to the following: uncontrolled
             hypertension,congestive heart failure, uncontrolled diabetes type I and II

         10. Subjects with evidence of hepatic or blood coagulation disorders (i.e. hemophilia,
             etc), anemia, idiopathic thrombocytopenic purpura, or gastrointestinal disorder:
             severe hepatic disease, history of alcohol and drug abuse; disease of gall bladder and
             pancreas; active peptic ulceration, gastrointestinal bleeding or history of severe
             gastro-esophageal reflux disease or severe hiatus hernia; inflammatory bowel disease.

         11. Use of any therapeutic protein drug (e.g. anti-tumor necrosis factor alpha (TNFα)
             antibody)

         12. Presence of severe renal function impairment. History of renal trauma,
             glomerulonephritis, patients with one kidney, or renal failure requiring regular
             dialysis treatment.

         13. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a
             female after conception and until the termination of gestation, confirmed by a
             positive pregnancy test (serum or urine).

         14. Subjects with known contra-indications to naproxen (e.g. heart or circulation
             problems, history of ulcer disease etc.), analgesics, antipyretics, or NSAIDs.

         15. Disease of the spine or other lower extremity joints which may interfere with the
             assessment of the target joint.

         16. Surgery on the knee within the last year. Observational arthroscopy, arthroscopic
             surgery or lavage of the knee within the last 6 months.

         17. Use of assistive devices other than a cane (walking stick) or knee brace.

         18. Subjects who have experienced, any time in the past, asthma, acute rhinitis, nasal
             polyps, angioneurotic edema, urticaria or other allergic-type reaction after taking
             acetylsalicylic acid (ASA)/ aspirin or NSAIDs.

         19. Any history of prior peptic ulcer disease or prior NSAID gastrointestinal
             complications for the past 5 years.

        Other protocol defined inclusion/exclusion criteria may apply.
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.
Subject must be at most 80 Years

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? 1