Introducing a clinical study for people with active dermatomyositis or polymyositis
This study is evaluating an antibody treatment to see if it can be used safely and improve muscle symptoms in people with active idiopathic inflammatory myopathies (active dermatomyositis or polymyositis).
The study medicine is thought to work by blocking an immune system protein called interferon β (IFNβ), which is found in higher levels in people with dermatomyositis and polymyositis, and is thought to drive these diseases by causing inflammation of the skin and muscle.
Who may participate
Participating in a clinical study is an important and personal decision. Thank you for taking the time to consider the My(O)Path study as an option that may be right for you.
This clinical study may be an option for people aged 18 or older who have been diagnosed with active dermatomyositis or polymyositis.
To qualify for this study, you must be receiving a stable dose of 1 oral corticosteroid and/or 1 non-biologic or traditional immunosuppressant.
There are other eligibility requirements. A final decision on whether this clinical research study might be suitable for you will be made after you have completed the online and phone questionnaire and have been assessed by the research study staff who will also explain the benefits and risks of participation in this clinical research study.
Condition
Active dermatomyositis or polymyositis
Age
18+ years
Sex
Male or Female
Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the study.
Additional eligibility criteria
- You have active dermatomyositis or polymyositis with or without muscle weakness
- You are receiving a stable dose of 1 oral corticosteroid and/or 1 non-biologic or traditional immunosuppressant
- You do not have any other type of idiopathic inflammatory myopathy or myositis caused by other reasons
- You do not have any bacterial, viral, fungal, mycobacterial or other infection, especially tuberculosis
- You have not had clinically significant findings on a chest X-ray in the last 12 weeks
- You have not had any cancer within the last 5 years
- You have not received prior treatment with any type of anti-INFβ therapy
Get started — See if you may qualify
A first step as you consider this study is to answer a 5-minute questionnaire about your health and medical history. If your answers show the study might be a good fit for you, you may choose to be referred to a study clinic that you select.
You will then be asked to provide your contact information for a study representative to contact you and discuss the next steps. If you’re interested, they will do a more detailed review of your medical history to see if you are able to participate. Only the study staff can determine if you meet the study’s eligibility criteria and are able to enroll in the study.
Your answers to these initial questions will only be linked to you if your responses indicate that you may be eligible to participate in this study and you choose to share your contact information with the study team. Pfizer study team members and our partners will have access to reports containing aggregated data that will not be directly linked back to you.
What to expect
If you are a good fit for the study, you will be assigned by chance (like pulling a number out of a hat) to receive the study medicine or a placebo. You will have a 2 in 3 chance of receiving the study medicine and a 1 in 3 chance of receiving the placebo.
You will be asked to visit the study site about 15 times, once every 4 weeks. You will receive the study medicine or placebo through a tube and needle inserted in your arm known as an intravenous (IV) infusion. Each infusion will last an hour and you will stay for another hour to check for any possible reactions.
You will be allowed to continue with your current background treatment for dermatomyositis or polymyositis. If you are being treated with corticosteroids, your study doctor may start lowering the dose of corticosteroids during your time in the study.
Length of study treatment
12 months
Number of study visits
About 15 study visits
Long-term follow up
Option to receive PF-06823859 treatment and follow-up in the open-label extension study
Frequently asked questions
The study medicine is thought to work by blocking an immune system protein called interferon β (IFNβ). IFNβ is found in higher levels in people with dermatomyositis and polymyositis, and is thought to drive these diseases.
There are some risks associated with taking part in this study. Taking the study treatment (study medicine or placebo) could make your condition worsen, get better, or stay the same.
Side effects of the study medicine may range from mild to serious. A full description of the risks of taking part in this study are given in the informed consent document, which you will be provided with before agreeing to take part in the study.
Your health will be monitored throughout the study. If your health gets worse, a decision will be made between you, the study doctor and the study team about whether you should continue to participate in the study. Your health will be prioritized.
A placebo does not contain any active ingredients, but the study medication and the placebo look alike.
This means that neither you, the study doctor, or any of the study staff will know if you’re receiving active study medication or the placebo. This is done to prevent bias in the results of the study.
You may not receive any direct benefit from taking part in this study. However, by taking part you are helping contribute to research that may help other people with active idiopathic inflammatory myopathies in the future.
Yes. Taking part in this study is completely voluntary. You can decide to end your participation at any point during the study and this will not affect your regular medical care.
Your health information and any data that could be used to identify you (such as immigration status) will be kept private and safe. Only information that relates to the study will be collected, and only your study team, study doctor, and organizations that oversee the study will be able to access it. Your personal information won’t be shared with third parties such as the government or advertisers.
