Interested in Participating in a Trial for Osteoarthritis of the Knee?
This clinical research study is looking at the safety and effectiveness of an investigational medication option for people with pain due to osteoarthritis of the knee. This is dose-finding study of GSK3858279 in participants with moderate to severe knee osteoarthritis (OA) pain. The purpose of this study is to investigate and provide the data necessary to select the optimal effective and safe dose(s) of GSK3858279.
Would you like to take part?
As a volunteer in a research study, you’ll receive medical care related to the study from the study doctor, and regular follow up to monitor the effectiveness of the care you’ll receive. The results of this research will be used to find out if the experimental medication being studied will be of benefit to others or not. Study volunteers are an important part of moving medical care forward.
You may qualify to participate in this study if you:
- Are 40 to 80 years of age, inclusive
- Have OA of the index knee as defined by symptomatic for ≥ 6 months with a clinical diagnosis of OA as per American College of Rheumatology (ACR) clinical diagnosis criteria.
- Have a body mass index (BMI) of < 40 kilogram per meter square (kg/m^2) (inclusive).
- Are capable of giving signed informed consent.
You may not qualify to participate if you:
- Have a history or presence of cardiovascular, renal, gastrointestinal, lymphatic disorders which in the opinion of the investigator would interfere with the study procedures and/or assessments.
- Have a history or current evidence of any inflammatory arthritis such as rheumatoid arthritis, infective arthritis, Paget’s disease, osteonecrosis, osteoporotic fracture, or any other joint disease that in the Investigator’s opinion would interfere with the assessment of pain and other symptoms of osteoarthritis.
- Have a history of significant trauma or surgery to a knee or hip within the last 6 months.
- Have a current immunodeficiency disease including but not limited to acquired immunodeficiency disorder or immunoglobulin deficiency.
- Have current or previously active Mycobacterium tuberculosis
- Have a history or present evidence of clinically significant multiple or severe drug allergies
- Have a history of malignancy within the last 5 years, except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
- Have alanine transaminase (ALT) >1.5 times upper limit of normal (ULN).
- Have any current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert’s syndrome or asymptomatic gallstones)
- Show evidence of renal insufficiency, indicated by estimated creatinine clearance < 60 milliliter/ minute (mL/min)/1.73 m^2 at screening.
- Are sensitive to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.
There are other eligibility requirements that the study doctor will review. Only the study doctor can finally determine whether you are eligible to participate in the study or not.