Hope starts here
About Stride, a HOPE4OA™ clinical research study
If you’re living with moderate to severe knee pain due to OA and if other treatments haven’t worked for you, the Stride clinical research study may be an option. Researchers will be looking to see if an investigational medication effectively treats knee pain due to OA and improves function in the knee. The investigational medication will be given as an injection, twice a week, in your thigh or abdomen. Alternatively, you might be randomly selected to have a placebo injection which doesn’t contain active medication and is only used as a comparison.
This is a Phase III study, which means the treatment has already been tested for OA in previous Phase I and Phase II studies.
The hope is that researchers will find that this treatment will reduce pain and improve knee function.
More Trial Details:
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Study Duration:
Approximately 14-15 months (including treatment and follow-up)
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Treatment Period:
6 weeks of twice-weekly injections
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Follow-Up:
Up to 52 weeks after treatment
Estimated Enrollment
Approximately 466 participants
Phase
3Eligibility Criteria
Inclusion criteria
Participants must
- Be aged 18 years or over
- Have been living with moderate to severe knee pain for at least 6 months
- Have tried non-surgical options to manage your symptoms but they haven’t been effective in providing relief
Exclusion criteria
Participants must not
- Have a history of major bleeding disorders or recent gastrointestinal bleeding
- Have fibromyalgia or another pain condition that could interfere with assessments
- Are currently on certain restricted medications that aren’t allowed in the study
This is not a full list of criteria, your study team will ask you more questions to determine if you can take part
Disease Overview
What is Knee Osteoarthritis?
We understand that living with moderate to severe chronic knee pain due to OA can have a huge impact on your daily life. It can make simple routine activities difficult, make it harder to work, even stop you from going on walks or taking part in other physical activity. More than this, it can leave you feeling down and frustrated.
If you have OA in your knee, it means that the cartilage in your joint has begun to break down, slowly impacting the bone underneath. The most common symptom from this is pain in the knee, but it can reduce your knee function too.
What Will Happen in this Study
What Will Happen in this Study
Throughout the clinical research study, you’ll need to visit the study site (medical center) to be given the investigational medication or the placebo by injection in your thigh or abdomen, and to complete other assessments. Participants in the study will receive all study-related care and study medication at no cost.
Study Locations
Study Locations
See if You are Eligible
Other symptoms of OA in your knee include
Other symptoms of OA in your knee include:
- Aching or pain during or after moving (some people can feel this while sitting down too)
- Stiffness, especially when you first get up or after sitting down for a long time
- Swelling or puffiness
- Loss of flexibility such as not being able to bend and straighten your knee all the way
- Crackling noises or a grating sensation when you move your knee
- Your knee might feel wobbly or like it could give way
- Your knee might lock up or feel like it’s stuck
Unfortunately, there isn’t currently a cure for OA. There are only surgical and non-surgical options to help you manage your symptoms. This is why finding new options that may help treat symptoms is so important.
If you’ve tried to manage your symptoms with things like regular exercise, healthy eating, special devices and pain relief, but feel like your current medications and strategies aren’t enough, taking part in the Stride clinical research study could be an option.
Standard assessments you can expect:
Standard assessments you can expect:
Assessments allow the study team to monitor your health; learn about the impact the investigational medication or placebo is having on you and keep you safe. These will include (and may not be limited to):
- Physical exams
- Vital signs measurements (heart rate, blood pressure, etc.)
- ECGs
- X-rays
- MRI scans
- Urine tests
- Blood tests
- Eye exams
- Questionnaires
Not all of these will be needed at every visit; you will get a full break down of what will happen at each of your appointments so you know what to expect.
How long does the study last?
Your total participation will last around 14-15 months with up to 22 visits or phone calls to the study site. You’ll need to:
- Attend an initial screening visit to make sure you’re eligible to take part
- Attend clinic visits twice a week (every 3 to 4 days) during the 6-week treatment period
- Attend 7 follow-up visits (every 4-6 weeks) and 3 phone visits during the 52-week follow up period
