What are the Osteoarthritis Research Studies?
These studies are being done to determine the safety and efficacy
of an investigational medication in individuals with osteoarthritis. Arthritis is a
leading cause of pain and disability for people worldwide. Research has shown that Nerve Growth Factor (NGF) may play a role in the mechanisms that cause pain in the body.
Also, elevated levels of NGF are associated with disease states such as osteoarthritis.
This investigational medication is a monoclonal antibody that
binds to NGF and has
been shown to reduce pain in other research studies. As of October 2008, the investigational medication has been given to approximately 500 people
in completed research studies.
Over 6000 people are planned to take part in these research studies worldwide. Potential participants
will be evaluated for qualification, by
a study physician during an office visit. If you qualify, you will have the option
to join one of these research
studies. Before you decide to join, you will be informed in detail
about the research study and have a chance to have all your questions answered.
WHERE ARE THE RESEARCH STUDIES BEING CONDUCTED?
The research studies are being conducted at over 400 locations in the United States,
Canada, Eastern and Western Europe, Latin America and other countries throughout
the world.
HOW CAN I PARTICIPATE?
To qualify for these research studies, you must meet the study entrance criteria
below:
- You must be at least 18 years
of age
- You must have a diagnosis
of OA of the knee or hip
- You must not have participated in an anti-NGF study in the past
- You must not have participated
in another study of an investigational medication or medical device in the past
30 days
Other criteria apply that will be evaluated by the participating research site in
your area. Study participants who meet the entrance criteria for the study will be asked to come to the study physician’s office to receive the study medication. Study
medication will be delivered intravenously (injected directly into the vein) by
a study member over a 5 minute time period. Generally, clinic visits will last approximately 2 to 3 hours. These are randomized studies, which means you have a chance to receive the investigational
medication or placebo (medication with no active ingredients), or, in some studies, another pain medication. Neither you nor the
study physician will know what study treatment you will have been assigned to receive.
Most studies will allow you to use "rescue medication" acetaminophen /paracetamol
(Tylenol™) to be taken if you feel you are not receiving effective pain relief.
ARE THERE ANY RISKS?
All medications have risks. The study staff will review the Informed Consent document
with you, which includes a complete description of the known risks associated with
the investigational medication and research study participation.
WILL THIS STUDY BENEFIT ME?
Study participation provides you with a study-related health evaluation
and OA assessment, which may provide you and the study doctor with additional information
about your health. You will receive a study-related physical examination, electrocardiograms and
lab tests at no cost to you. The investigational medication may improve your pain
severity from OA; but this cannot be guaranteed.
As a study participant you are contributing to medical research and the understanding
of OA. Information gathered from this study may help researchers develop better
future
treatments for pain and other signs and symptoms of OA.