Question 1

What is the purpose of a clinical study?

Accepted Answer

Clinical studies (also called clinical trials) are used to learn about the safety and effectiveness of new medications, medical devices, and medical procedures. Although there are many types of clinical trials, all must conform to strict rules set by each country’s regulatory authorities. These rules help protect the rights and safety of those who volunteer to take part in clinical trials.

Question 2

Has the study medication been used before?

Accepted Answer

Yes, the study medication has been used before in a trial of 486 participants for knee OA. In this study, the study medication will be tested as an injection under the skin (in the abdomen or thigh) for the treatment of knee osteoarthritis. Since the study medication has not yet been approved for this indication, it is considered investigational for the purposes of this study.

Question 3

Has the study medication been used before for knee OA?

Accepted Answer

Yes, in a previous clinical studies and expanded access programs  with 486 participants with knee osteoarthritis, it was shown that twice weekly injection of the study medication was effective in reducing knee pain. Those study results supported further research of the study medication for knee osteoarthritis pain.

Question 4

How many people will participate in this study?

Accepted Answer

This study will enroll up to 466 men and women with knee osteoarthritis at select study locations in the USA and Australia.

Question 5

Does everyone in the study receive the investigational medication?

Accepted Answer

No, as part of the study participants will be randomly assigned (like rolling a dice) to receive either the investigational medication (50% chance) or a placebo medication (50% chance). The placebo medication looks just like the investigational medication but has no active ingredient. Neither you nor your doctor will know which medication you receive. This is a common technique in clinical studies, as it helps doctors and researchers understand the effects of the investigational medication without bias

Question 6

Will I have to pay for anything if I choose to join the study?

Accepted Answer

No, participants in the study will receive all study-related care and study medication at no cost. Health insurance is not required to participate. You will be compensated for your time and travel to attend required visits at your study doctor’s office

Question 7

How long does the study last?

Accepted Answer

The study lasts about 15-16 months. Following an initial Screening Period of 6-7 weeks to confirm if you are eligible to join the study, you will begin the Treatment Period (about 6 weeks). During the Treatment Period, you will visit your study doctor’s office twice per week for 6 weeks to receive the study injection. Once the Treatment Period has ended, you will enter a Follow-Up Period (about 12 months) to understand how the treatment worked for you. The Follow-Up Period involves 9 total visits to your study doctor’s office, the first 5 about one month apart and the last 4 about two months apart.

Question 8

What if I join the study and decide I do not want to participate anymore?

Accepted Answer

As with all clinical studies, your participation is completely voluntary. You may leave the study at any time without any effect on your future medical care

Question 9

I am interested in possibly moving forward.  What is the next step?

Accepted Answer

Please contact your local study center, and they will work with you to schedule a convenient time for your initial visit.

FAQ

AM I ELIGIBLE FOR THIS TRIAL?

TAKE THE QUESTIONNAIRE

To check if you are eligible to take part in the HOPE4OA trial, answer a few simple questions below.

GET THE FACTS

For more detailed information about the Hope4OA trial and its requirements, click below.

HOPE4OA is a knee osteoarthritis trial supported by: