An Exploratory Clinical Study to Investigate Biomarkers of Senescence in Patients With Osteoarthritis of the Knee

Completed · Not applicable

Conditions studied: Osteoarthritis, Knee

In brief

This is an exploratory non-drug, interventional biomarker study in approximately 30 eligible patients with active osteoarthritis to investigate the degree of senescence-associated disease. Patients will provide blood and urine and undergo MRI imaging with and without gadolinium enhancement. Following imaging, arthrocentesis of both knees and an arthroscopy of the target knee will occur to obtain fluid, synovium and cartilage for analysis.

Key facts

Study ID

NCT03100799

Run by

Unity Biotechnology, Inc.

People needed

30

Starts

2017-03-02

Expected to finish

2017-07-10

Last updated by the study team

2017-08-01

Who can join

Age: 35 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must be diagnosed as having primary (idiopathic) femoro-tibial osteoarthritis (OA) of the knee as defined by a modified version of the American College of Rheumatology Criteria (modified clinical and laboratory criteria) for at least 6 months.
• Kellgren-Lawrence (KL) score of grade 1 to 4 inclusive based on a standardized, semi-fixed, weight-bearing radiograph of the knee.
• Adults of age ≥ 35 years
• Body Mass Index less than or equal to an upper limit of 35 kg/m2
• Patients who are able to commit the time required to attend all study visits
• Normal clinical laboratory results with no clinically significant organ dysfunction which, in the opinion of the investigator, would preclude patient from entering the study

You may not qualify if…

• Any condition, including laboratory findings and findings in the medical history or in the pre-study assessments, that, in the opinion of the Investigator constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct or evaluation
• Prior open knee surgery to the target knee including but not limited to Anterior Cruciate Ligament Repair
• Patients who have had prior arthroscopy and intraarticular treatments for the management of osteoarthritis such as administration of hyaluronic acid or corticosteroids within the last 6 months
• Patients with traumatic knee injury who are scheduled for arthroscopic repair procedures to either target or non-target knee
• Patients who are deemed to be at risk of acute renal insufficiency of any severity due to hepato-renal syndrome or who are in the peri-operative liver transplant period.
• Patients with Diabetes Mellitus.
• Patients with renal dysfunction as defined by a Glomerular Filtration Rate <60 ml/min/1.73m2 by laboratory testing.
• Known allergic or hypersensitivity reaction to gadolinium-based contrast agents or patients who have other contraindications for MRI
• Patients requiring anticoagulation therapy other than low dose (81 mg or less) aspirin
• Treatment with an unapproved investigational therapeutic agent and/or experimental therapeutic procedure on the target knee within 24 weeks prior to screening
• Any active known or suspected systemic autoimmune disease Permitted on Study
• vitiligo
• residual hypothyroidism due to autoimmune condition only requiring hormone replacement
• psoriasis not requiring systemic treatment for 2 years
• conditions not expected to recur in the absence of an external trigger Excluded on Study
• documented history of inflammatory bowel disease (including ulcerative colitis and Crohn's disease)
• symptomatic autoimmune conditions (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma])
• systemic lupus erythematosus
• autoimmune vasculitis (e.g. Wegener's Granulomatosis)
• patients with motor neuropathy considered of autoimmune origin (e.g. Guillain-Barré Syndrome)
• History of previous surgery (Total or Partial Knee Replacement) on the Target knee
• Lesions at the planned site of arthroscopy which would present a contraindication to the procedure such as open wounds or infection of the skin
• Any known active infection, including suspicion of intra-articular infection and/or infections that may compromise the immune system such as HIV, Hepatitis B or Hepatitis C infection
• History of sarcoma and/or history of other active malignancy within the last 5 years, except basal cell carcinoma, carcinoma in situ of the cervix and squamous cell carcinoma of the skin
• Secondary osteoarthritis, including:

Where it is running

• The Arthritis Treatment Center — Frederick, Maryland, United States

Full record on ClinicalTrials.gov

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