Two trials – Tanezumab in Osteoarthritis of the Knee (at 66 clinical centers), and Tanezumab in Osteoarthritis of the Hip (79 centers) – are now recruiting across the U.S.
The Phase 3 placebo-controlled trials will measure ability of the monoclonal antibody drug tanezumab to improve pain, stiffness, and physical function. Therapy will involve IV administration every 8 weeks for 32 weeks – in four trial arms involving 3 different dosages and a placebo group.
WHO MAY BE ELIGIBLE: The trial sites are recruiting patients 18 years and older, ACR diagnosed with osteoarthritis of the knee or hip and:
• Unwilling or unable to take non-opiate pain meds such as NSAIDS
• Or for whom non-opiate meds have not provided adequate pain relief
• Or who are candidates for hip/knee injections, arthroplasty, or replacement surgery.
• Willing to discontinue pain meds before & during study (excepting acetaminophen up to certain level)
WHAT IS A MONOCLONAL ANTIBODY/TANEZUMAB?
A monoclonal antibody is a laboratory-produced substance that can bind to specific protein molecules – in this case to nerve growth factor which arises at sites of inflammation and is thought to worsen pain. (For example, tanezumab has been shown in a previous study of patients with knee osteoarthritis who hadn’t been helped by NSAIDS to improve knee pain, physical function & stiffness significantly.)
WHY AN ALTERNATIVE TO NSAIDS?
NSAIDS – nonsteroidal anti-inflammatory drugs – such as aspirin, ibuprofen, and naproxin (e.g., Aleve) work by inhibiting cyclooxygenase (COX), an enzyme that encourages inflammation. They all involve some risk, ranging from aspirin’s potential effects on the stomach lining to blood pressure, heart, and kidney problems. NSAIDS reportedly reduce inflammation in about 60% of patients, and about 10% don’t benefit from any NSAID.
TO LEARN MORE
About these trials, including inclusion/exclusion criteria and the trial site listings, and to contact a trial site near you, go to the ClinicalTrials.gov pages for:
NOTE: A THIRD TRIAL, not yet recruiting and targeting 800 participants – Tanezumab in Osteoarthritis of the Knee(2) – will test tanezumab by comparison with the NSAID naproxen. For information about this trial, go to www.clinicaltrials.gov/ct2/show/NCT00830063