Description:

First-in-human Single Ascending Dose Study of LNA043 in Patients Scheduled for Total Knee Replacement; ODM derived from: https://clinicaltrials.gov/show/NCT02491281

Link:

https://clinicaltrials.gov/show/NCT02491281

Keywords:
Versions (1) ▾
  1. 6/15/19
Copyright Holder:
See clinicaltrials.gov
Uploaded on:

June 15, 2019

DOI:
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License:
Creative Commons BY-NC 3.0
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Eligibility Primary Osteoarthritis Patients Scheduled for Total Knee Replacement Surgery NCT02491281

Eligibility Primary Osteoarthritis Patients Scheduled for Total Knee Replacement Surgery NCT02491281

Criteria
male and female patients age 50 to 75 years of age inclusive, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening
patients diagnosed with primary osteoarthritis of the knee assessed locally with a disease grade 3 or 4 as determined by the kellgren & lawrence scale for whom a total knee replacement is planned
general health status acceptable for total knee replacement surgery in the opinion of the investigator
stable medications consistent with standard of care (such as appropriate pain medication, antibiotics prophylaxis) are acceptable within 6 month prior enrollment
key exclusion criteria:
presence of inflammatory arthropathy (including but not limited to rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, gout), active acute or chronic infection, or systemic cartilage disorder
prior cartilage repair surgery, e.g. microfracture, autologous cartilage implantation (aci) or else, at the same knee
any surgical therapy or local treatment i.a. into the knee (viscosupplementation) to the knee within 6 months prior to enrollment
bmi > 35; presence of uncontrolled diabetes or hyperthyroidism
large effusion in the knee to be replaced, <1 cm fluid in the suprapatellar space at the midline
corticosteroid use by any route except topical within 3 months prior to enrollment
history of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in-situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases
pregnant or nursing (lactating) women
women of child-bearing potential, defined as all women physiologically capable of becoming pregnant