Double-Blind, Randomized, Single Dose Escalation Safety Study of Intraarticular Bone Morphogenic Protein (38A BMP-7) in Subjects With Osteoarthritis (OA) of the Knee
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Stryker Biotech
Age
40–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Ambulatory with a diagnosis of OA of the knee with symptoms for at least 6 months and pain on the majority of days in the last 30 days.
\>40 years
Radiographic evidence of at least one osteophyte in either knee at screening
You may not be if
Concurrent medical or arthritis condition that could interfere with evaluation of index knee joint (including fibromyalgia)
Unwilling to abstain from NSAIDs and/or other analgesic medications for 48 hrs prior to assessments. Subjects can remain on acetaminophen up to 3.0 g daily.
Received arthroscopic or open surgery to the index knee within 6 months of screening
History of joint replacement surgery (index knee).
Corticosteroid, short acting hyaluronic acid, or other intraarticular injections of the index knee within 3 months of screening
Long acting hyaluronic acid injection of the index knee within 6 months of screening
History of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, lymphoma, and arthritis associated with inflammatory bowel disease, sarcoidosis, amyloidosis or fibromyalgia.
History of malignancy with the exception of resected basal cell, squamous cell of the skin, resected cervical atypia or carcinoma in situ.
Female subject with reproductive capability.
Clareo Health | Double-Blind, Randomized, Single Dose Escalation Safety Study of Intraarticular Bone Morphogenic Protein (38A BMP-7) in Subjects With Osteoarthritis (OA) of the Knee
