Walgreens and AbbVie are seeking volunteers for a rheumatoid arthritis (RA) clinical trial.
Join us in SELECT-SWITCH comparing the efficacy and safety of two approved medications for people with RA.
Study Overview
Why is the SELECT-SWITCH study important?
This study will compare the efficacy and safety of 2 approved medications, in people with moderate to severe RA who did not benefit from or could not tolerate a single tumor necrosis factor inhibitor (TNFi) therapy (a type of advanced arthritis treatment).
If you haven’t responded to a previous TNFi treatment, or have experienced side effects, switching to a different TNFi or initiating a Janus kinase inhibitor (JAKi), a different type of advanced arthritis treatment might help.
To date, there have been no studies to evaluate which treatment could be more effective in patients who failed a single TNFi therapy. This study will help explore potential treatment strategies.
Eligibility Criteria
You may be eligible if:
You are 18 years of age or older
You have been diagnosed with RA for at least 3 months
You have been treated with only 1 TNFi, such as certolizumab pegol, etanercept, golimumab, or infliximab, for at least 3 months, but you still have active RA or had to stop due to side effects
You have been on methotrexate therapy for at least 3 months
There are additional study criteria that the study team will discuss with you.
Taking part in the study involves:
Learning about the details of the study and giving your consent to participate.
A screening period, 2 treatment periods, and post-treatment follow-up visits.
The study will last about 1 year
Taking a once-daily tablet and receiving a subcutaneous injection (under the skin) every other week.
If you qualify and choose to join SELECT-SWITCH, the study doctor will assign you to a study group. Depending on your group, you will receive the active oral study drug or a placebo (inactive) pill and the active injectable study drug or a placebo (inactive) injection.
This study is double-blind, meaning neither you nor the study doctor will know which active medication you received until all patients complete the study and the data are analyzed.
Frequently
asked questions
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Clinical research is the process of developing medicines, therapies, or treatment strategies to possibly prevent, treat, or help with diseases. Clinical studies help researchers evaluate these medicines, therapies, or treatment strategies to understand if they are safe and effective. With the help of clinical study participants, researchers are able to find out if and how potential new medicines or therapies work or what their role is in the treatment strategy.
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It allows you to take an active role in your own health care, contributing to research that could lead to advancements in RA therapy and could benefit thousands of people with this condition in the future.
Additionally, during the trial, you will receive close monitoring and support from a dedicated team of health care professionals, which could lead to a better understanding of your condition and personalized care.
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In this clinical trial, you can expect a thorough and supportive process starting with an informed consent session, where all aspects of the study, including its purpose, procedures, potential benefits, and risks, will be explained in detail. Following your informed consent, you'll undergo a screening process to ensure your eligibility. This includes a comprehensive review of your medical history, a series of laboratory tests, and a physical examination, focusing on your RA and overall health status.
Throughout the study, you will be closely monitored for any side effects with regular assessments to track your health and response to the treatment. This includes patient-reported outcomes on how you're feeling and routine clinical laboratory tests. You'll also receive the study drug and detailed instructions on its administration at no cost, with follow-up visits to assess your progress and manage any side effects.
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Tumor necrosis factor inhibitors (TNFi) are drugs that can stop inflammation and are used worldwide to treat inflammatory conditions, like RA.
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Janus kinase inhibitors (JAKi) are drugs that work by decreasing the activity of the immune system. They are used in the treatment of inflammatory conditions, such as RA.
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Yes. You can decide to stop at any time. Just tell the study researcher if you wish to stop being in the study. You do not need to give a reason why you want to stop participating.
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Participants may be eligible for compensation for their time and travel expenses related to the study. Details will be provided upon confirming eligibility.