Clinical trial: Study to Evaluate the Effects of Fasinumab on Peripheral Nerve Function in Patients With Pain Due to Osteoarthritis of the Hip or Knee (NCT03691974)

Eligibility criteria:
Key Inclusion Criteria:

          1. A 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

          2. Moderate-to-severe pain in the index joint defined as a WOMAC average pain subscale
             score of ≥4 at both the screening and randomization visits

          3. Willing to discontinue current pain medications and to adhere to study requirements
             for rescue treatments

          4. A history of regular use of analgesic medications for OA pain (defined as an average
             of 4 days per week over the 4 weeks prior to the screening visit), including oral
             nonsteroidal anti-inflammatory drugs (NSAIDs), selective cyclooxygenase 2 inhibitors,
             opioids, paracetamol/acetaminophen, or combinations thereof

          5. Consent to allow all radiographs and medical/surgical/hospitalization records of care
             received elsewhere prior to and during the study period to be shared with the
             investigator

        Key Exclusion Criteria:

          1. History or presence at the screening visit of non-OA inflammatory joint disease (eg,
             rheumatoid arthritis, lupus erythematosus, psoriatic arthritis, pseudo-gout, gout,
             spondyloarthropathy, polymyalgia rheumatica, joint infections within the past 5
             years), Paget's disease of the spine, pelvis or femur, neuropathic disorders, multiple
             sclerosis, fibromyalgia, tumors or infections of the spinal cord, or renal
             osteodystrophy

          2. History or presence on imaging of arthropathy (osteonecrosis, subchondral
             insufficiency fracture, rapidly progressive OA type 1 or type 2), stress fracture,
             recent stress fracture, neuropathic joint arthropathy, hip dislocation (prosthetic hip
             dislocation is eligible), knee dislocation (patella dislocation is eligible),
             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 fractures during the screening period

          3. Trauma to the index joint within 3 months prior to the screening visit

          4. History or presence of signs or symptoms of compression neuropathy, including carpal
             tunnel syndrome or sciatica

          5. Participant is not a candidate for Magnetic Resonance Imaging (MRI)

          6. Poorly controlled diabetes

          7. Known history of human immunodeficiency virus (HIV) infection

          8. Known history of ocular herpes simplex virus, herpes simplex virus pneumonia, or
             herpes simplex virus encephalitis

          9. History of poorly controlled hypertension

         10. Known history of infection with hepatitis B or C virus

        Note: Other protocol defined Inclusion/Exclusion 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? 1