New treatments for rheumatoid arthritis cannot be developed without the help from clinical trial participants, also known as volunteers. Through clinical research we are finding out if investigational medicines medicines being studied may help people with rheumatoid arthritis.
If you are thinking about participating in a clinical trial, you might have a lot of questions. In this section, we give you information about diverse representation in clinical trials and how participant wellbeing is protected. We also give you some information about what to expect before, during and after a trial. This information and talking to your doctor, research team and loved ones, may help you decide if a clinical research study is the right path for you. You can visit our Clinical Trial Information page for more information.
Diverse Representation
Clinical trials may not always represent diverse communities. At Lilly, we are trying to change this to give everybody the chance to participate. We want to include people of all races, ages, ethnicities, genders, and body weights who may potentially benefit from taking part in a clinical trial.
Genetic or physical differences between people can mean that some might react differently to a medicine or treatment. For these reasons, it is important to represent all people who may need the medicine or treatment in clinical trials.
Participant Wellbeing
How is participant wellbeing protected during a clinical trial?
One of the responsibilities of the healthcare team who run clinical trials is to care for participants. The healthcare team is typically made up of doctors, nurses, and trained researchers. This means that they are trained to look after your safety and health.
Clinical trials also have a regulatory and ethical framework to protect participants. Everyone conducting a clinical trial has strict regulatory and ethical duties. Teams of people, called an Ethics Review Board (ERB) or Institutional Review Board (IRB), operate independently from the day-to-day conduct of research. An ERB or IRB reviews every clinical trial before people can take part. This is to ensure that the correct steps are taken to protect participants' welfare and rights. An ERB or IRB protect participants by:
making sure that clinical trial risks are as low as possible for participants;
ensuring the potential benefits of the clinical trial outweigh the risks; and
making sure that a clinical trial meets overall safety requirements for participants.
After joining a trial, can a participant stop taking part?
A participant may stop taking part in a clinical trial at any time, for any reason. No matter the stage of the trial, a participant has the right to change their mind and withdraw. If a participant decides to withdraw, the study doctor will remove them from the trial in a way that is safe for the participant.
Impact and Results
As a clinical trial participant, you would contribute to the long history of volunteers around the world. Together, trial participants help researchers answer important health questions and discover new medical treatments.
Once a clinical trial is complete, the results will be available online. You can search for completed Lilly clinical trials on our completed trials page.
What to Expect
How do I know if I, or someone I know, can participate in a trial?
Each clinical trial has a set of rules for who can participate, these are usually called ‘inclusion and exclusion criteria’. The rules may require a participant to:
have a certain level of disease (such as mild, moderate, or severe);
be within a particular age range; and
have a specific medical history.
These rules help protect participants and help to answer research questions. Potential participants go through a screening process to see if they fit the rules. If a person does not qualify for one study, another study could be a better fit.
When it comes to medical history, there are some areas that the study team may focus on. They will ask you about your rheumatoid arthritis symptoms and severity. The study team may ask you questions about your history of:
infections like HIV, hepatitis B, hepatitis C, and tuberculosis (TB)
blood clots such as deep vein thrombosis (DVT)
heart attack, stroke or other cardiovascular (heart and blood vessel) conditions
surgery, or if you have any planned surgery
cancer
medication use
clinical trial participation
They may also want to make sure you agree to use contraception if you can get pregnant, or if you can get someone else pregnant.
What happens before joining a trial?
Before joining a clinical trial or completing any trial-related activities, potential participants are given information about the study and have the chance to ask questions. This process is called informed consent.
The informed consent process will help you understand:
the purpose of the clinical trial;
what will happen during the clinical trial; and
the risks and benefits of taking part.
Informed consent begins before a person agrees to participate in a trial or completes any trial-related activities and continues throughout the study.
What tests and assessments are used in rheumatoid arthritis clinical trials?
For rheumatoid arthritis clinical trials, participants may need to visit the study doctor more often than they would for normal care. During the clinical trial, there are different types of assessments. These may include:
Physical exams
In these exams the study doctor may focus on areas that can be affected by rheumatoid arthritis such as the joints, skin, and eyes.
They will also usually listen to your heart and lungs and check if your abdomen (belly) is tender by gently pressing on the area.
Lab tests and other assessments
Blood samples
To check for infections, your blood count, cholesterol levels, how organs like your liver and kidneys are working, and if you are pregnant. They may also look for rheumatoid arthritis markers in the blood.
Other measurements
Weight, height, and vital signs such as your temperature, heart rate and blood pressure are also recorded.
Patient Reported Outcomes (PRO) Questionnaires
Rheumatoid arthritis can have far-reaching impacts on a person's social and emotional well-being and quality of life. An important part of clinical research studies is to assess the impact the condition is having on these different areas. This is usually done by completing questionnaires designed for this purpose.
What happens once a participant finishes the trial?
After the trial, a participant should work together with their primary doctor to figure out the best next steps and care plan.
The investigational medicine (the medicine that was studied) may need to be looked at in more clinical trials. It may also be reviewed by regulatory agencies and approved for use outside of a clinical trial.
Rheumatoid Arthritis (RA) Research
Rheumatoid arthritis (RA) can impact people of all ages and from all countries. It can be difficult to manage and may impact quality of life.
Rheumatoid arthritis is a chronic (long term) autoimmune condition that causes joint pain, stiffness and swelling. It usually affects the hands, feet, and wrists, but it can affect other joints.
People living with rheumatoid arthritis can also experience more general symptoms, these include:
tiredness and lack of energy
a high temperature
sweating
a poor appetite
weight loss
The chance of developing rheumatoid arthritis is higher in certain circumstances. You may have an increased risk of developing it if you:
have a family history of the condition,
smoke, or,
are a woman.
With clinical research, we can find more convenient and effective ways to manage rheumatoid arthritis, and potentially prevent flares (when symptoms get worse) or reduce their duration. View rheumatoid arthritis clinical trials.
Lilly Trial Connect
Answer a few questions using Lilly Trial Connect to find which Lilly trials may be the best fit for you or your loved one.
Answer a few questions using Lilly Trial Connect to find which Lilly trials may be the best fit for you or your loved one.