Clinical trial: A Study to Assess Efficacy and Safety of GLPG1972/S201086 in Patients With Knee Osteoarthritis (NCT03595618)

Eligibility criteria:
Inclusion Criteria:

          -  Male patients or female patients of non-childbearing potential Age between 40 to 75
             years (both inclusive).

          -  Body weight > 40 kg, body mass index (BMI) < 40 kg/m2.

          -  Diagnosed for knee osteoarthritis based on clinical and radiological criteria of the
             American College of Rheumatology.

          -  History of knee pain for at least 6 months and on the majority of days (> 50%) during
             the preceding month.

          -  Symptom severity defined by a pain ≥ 40 mm and ≤ 90 mm on VAS (100 mm).

          -  Documented need for symptomatic as needed-treatment for OA in the target knee with
             systemic non-steroidal anti-inflammatory drugs (NSAIDs) and/or other analgesics

        Exclusion Criteria:

          -  Severe clinical knee malalignment according to the investigator.

          -  Knee prosthesis already implanted (< 1 year) or not well-tolerated (contralateral
             side).

          -  Knee prosthesis already foreseen within the study period (whichever side)

          -  Hip prosthesis recently implanted (< 1 year) or foreseen within the study period
             (whichever side).

          -  Previous osteotomy on the inferior limbs (whichever side).

          -  Surgical operation on the target knee within the 12 months prior to the screening
             visit or planned during the study.

          -  Arthroscopy of the target knee within the 6 months prior to the screening visit or
             planned during the study.

          -  Other pathologies affecting the knee.

          -  Any contraindication to MRI including the inability to undergo a knee MRI exam because
             of inability to fit in the scanner or knee coil.
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 75 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? Entailment