Paisley Study | Study Connect

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Lupus can make life challenging and unpredictable - you never know when symptoms will flare.

It can be tiring, when you never know when your symptoms will flare. If you are one of the many people living with Lupus Nephritis, consider a clinical trial, you may be able to give something back to others like you.

The information you provide is completely confidential and will only be disclosed with your permission except as required by law.

Check Your Eligibility

What does the Paisley LN clinical research study involve?

Doctors around the world are working hard to try and find new ways to treat Lupus Nephritis (LN) and they need help. You see, study participants are at the heart of any study. Without them, clinical research studies simply would not be possible. And without clinical research studies, no new LN drugs can be developed.

The Paisley LN study want to see how safe and effective a study drug is at reducing the symptoms of moderate to severe LN. We are looking for adults 18-75 years of age with a diagnosis of moderate-to-severe LN. The Paisley LN study is looking for approximately 100 participants.

How long is the Paisley LN Study?

The Paisley LN Study lasts about 125 weeks (or about 2.5 years). If you are eligible and are referred to the study clinic, the study team can provide you with more information about the study visits that are required.

You won’t be asked for any personal information until after you have completed the questionnaire and decided to proceed. Your information will only be used for the purposes of this study.

Supporting your loved one

Question:

Why do people take part in clinical studies?

Answer:

People take part in clinical trials for a variety of reasons that are unique to them. Some people may decide to take part because they want to help researchers understand a disease better, or find potential new treatments for people in the future. Sometimes enrolling in a clinical trial gives people access to an investigational drug – something that may be of interest when all approved treatment options have been exhausted.

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Question:

Are clinical trials safe?

Answer:

The safety of participants is the number one priority in any clinical trial. While no one can guarantee that an investigational drug won’t cause any side effects, the health of every participant is monitored closely by the trial team to ensure that any side effects that do arise are managed effectively.

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Question:

How might my loved one be affected by participating in a clinical trial?

Answer:

Clinical trials often involve additional doctor visits, and these may impact your loved one’s daily routine. Some participants may also experience discomfort from trial procedures or side effects from the investigational drug.

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Question:

My loved one is participating in a clinical trial. How can I support them?

Answer:

There are lots of ways to support a loved one as they take part in a clinical trial. Transporting your loved one to their clinic visits or reminding them of things they need to bring with them may help them manage their stress. You could even take notes of symptoms they experience on their behalf, as these are often helpful to researchers. And of course, supporting your loved one by simply being present, listening and offering encouragement is also really valuable.

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About the Paisley Study

Who can participate in a clinical trial?

Only participants who meet all required eligibility criteria for a clinical trial may take part. The study team at the clinic you select will review your medical history and current medical status against the eligibility criteria. They will determine if you are eligible to participate in the trial. You may also be asked to provide information from your medical records to help the study team determine if you could be eligible.

Why is this clinical trial being conducted?

The purpose of the Paisley LN Study is to evaluate how well the oral investigational drug works and how safe it is in patients with LN.

What happens if I pre-qualify?

If you pre-qualify and decide to participate, you may be referred to the nearest study clinic for a screening visit. At the study clinic, you may meet with the study team to go over the Informed Consent Form, review additional participation criteria, and take part in an initial evaluation/test to determine your study eligibility.

How do I decide if this clinical trial is right for me?

Before you agree to participate, the study team will review all aspects of the clinical trial with you, including required study assessments. You will be given a document called an Informed Consent Form that provides, in writing, the clinical study's purpose, assessments, procedures, benefits, risks, and precautions. You will have the opportunity to ask questions and are encouraged to speak with your own physician to decide if taking part is right for you.

Who can I contact with more questions?

The study doctor and research nurse can provide more information and answers to your questions.

Will I be paid for taking part/reimbursed for travel?

You will not be paid for taking part in the clinical trial. You may be responsible for other costs (for example, tests you would receive as part of regular care for your condition), some of which may be covered by your insurance. The study team can inform you about reimbursement for reasonable travel expenses incurred to attend study visits if you are eligible and are referred to a clinic.

About the Investigational Drug

Why is the investigational drug being studied?

The oral investigational drug is being evaluated to see how well it works and how safe it is for patients with LN. You may be able to continue your current LN disease medication along with the oral investigational drug.

What is the name of the investigational drug?

Because this drug is still being evaluated and has not been approved by a health authority, it does not have a name. Instead, it is referred to as BMS-986165.

What is a placebo?

A placebo is an inactive drug sometimes given to a control group. Placebos are used so investigators can compare it to the experimental drug being studied. In cancer trials, patients are provided with at least the standard of care and a placebo is not used.

What are the chances of receiving the placebo

If you participate in the Paisley LN Study, during the initial study phase you will have a 1 in 3 chance of receiving the investigational drug and a 1 in 3 chance of receiving the placebo.

We strongly recommend you contact BMS to report Side Effects (Adverse Events)
Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information

Have questions? Live support is available 24/7 - Call 855-907-3286 or email clinical.trials@bms.com

Have questions? Live support is available 24/7 -

Call 855-907-3286 or email clinical.trials@bms.com