Clinical trial: Long-Term Safety and Efficacy Study of Fasinumab in Patients With Pain Due to Osteoarthritis (OA) of the Knee or Hip (NCT02683239)

Eligibility criteria:
Key Inclusion Criteria:

          1. Male or female ≥18 years of age at the screening visit

          2. Clinical diagnosis of OA of the knee or hip based on the American College of
             Rheumatology criteria with radiologic evidence of OA (K-L score ≥2) for the index
             joint at the screening visit

          3. Moderate to severe pain in the index joint defined as a Western Ontario and McMaster
             Universities Osteoarthritis Index (WOMAC) average pain subscale score of ≥4

          4. A history of 12 weeks of analgesic use for OA of the knee or hip

          5. History of regular use of analgesic medications for OA pain

        Key Exclusion Criteria:

          1. History or presence at the screening visit of non OA inflammatory joint disease

          2. History or presence on imaging of arthropathy, stress fracture, recent stress
             fracture, neuropathic joint arthropathy, hip dislocation, knee dislocation, congenital
             hip dysplasia with degenerative joint disease, extensive subchondral cysts, evidence
             of bone fragmentation or collapse, or primary metastatic tumor with the exception of
             chondromas or pathologic fracture during the screening period

          3. Signs or symptoms of carpal tunnel syndrome within 6 months of screening

          4. Patient is not a candidate for MRI

          5. Is scheduled for a joint replacement surgery to be performed during the study period

          6. Systemic (i.e., oral or intramuscular) corticosteroids within 30 days prior to the
             screening visit.

          7. History or presence at the screening visit of multiple sclerosis, autonomic
             neuropathy, diabetic neuropathy, or other peripheral neuropathy, including reflex
             sympathetic dystrophy

          8. History or diagnosis of chronic autonomic failure syndrome including pure autonomic
             failure, multiple system atrophy

          9. Pregnant or breast-feeding women

         10. Women of childbearing potential who have a positive pregnancy test result or do not
             have their pregnancy test result at baseline

        Note: Other protocol defined Inclusion/Exclusion criteria apply
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 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes.  The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief.  Past medical history is notable for hypertension and hypercholesteremia.  Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints.

Patient description (patient's own words): I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints.

Does the patient match the trial criteria? Entailment