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Regeneron Osteoarthritis Study
||A Phase 3 Randomized, Double-Blind, Multi-Dose, Placebo and NSAID-Controlled Study to Evaluate the Efficacy and Safety of Fasinumab in Patients with Pain due to Osteoarthritis of the Knee or Hip
||Steven C. Vlad, MD, PhD
|| Vivian Deng
This study evaluates the efficacy and safety of fasinumab compared to placebo, diclofenac, and celecoxib (diclofenac and celecoxib are standard-of-care non-steroidal anti-inflammatory drugs, NSAIDs, used for moderate-to-severe pain due to OA). The study drug will be administered for up to 24 weeks in patients with OA of the knee or hip. Fasinumab aims to selectively block nerve growth factor (NGF), a protein that causes pain. Blocking NGF may reduce pain due to OA of the hip and knee. Fasinumab is being test and is not approved for use in pain management by the United States Food and Drug Administration (FDA).
- Subject must have clinical diagnosis of osteoarthritis of the knee or hip
- Subject must have a history of at least 12 weeks of analgesic use for pain due to OA of the knee or hip
- Subject must be willing to have X-rays and MRI(s)
- Subject with current diagnosis of other inflammatory joint disease
- Subject who has a history of NSAID intolerance, or known allergy or sensitivity to doxycycline or related compounds, or monoclonal antibodies or sulfa drugs
- Subject who is breastfeeding or pregnant
The Regeneron study will require a total of 11 in-office study visits, 2 telephone contacts, and any additional visits for MRI(s) over a total of 77 weeks. At the study visits, your vital signs will be taken and you will be examined by the study doctor. Blood and urine samples will be collected at these visits. Approximately 14.5 tablespoons (215 mL) will be collected from you during the entire study. You will have 4 to 6 X-rays of both knees, both hips, and both shoulders for research purposes. MRIs may be performed during the screening period and may be repeated at a later time in the event of worsening of joint pain.