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Living with Sjögren's Syndrome can be a constant struggle

About Sjögren’s Syndrome (Sjögren’s)

Sjögren’s is an autoimmune disease, which means that your immune system mistakenly attacks healthy cells in your body¹. Dry eyes and mouth are the most common symptoms.

Sjögren’s affects the glands in your body that produce moisture, such as the glands that create saliva and tears. This typically causes a painful dry, burning sensation in your eyes, and dry mouth that can make it difficult to talk and chew, and can cause dental issues. Along with symptoms of extensive dryness, complications may get more serious as time goes on and can include vision problems, severe dental cavities, fatigue, chronic pain, and problems with major organs.

¹ https://www.mayoclinic.org/diseases-conditions/sjogrens-syndrome/symptoms-causes/syc-20353216. Accessed November 8, 2019. 

Check Your Eligibility

What is a research study?

Research studies—also called clinical research studies, or clinical trials—are scientific studies that explore whether an investigational drug is safe and effective for patients. Research studies are important because they may:

Answer specific health questions
Help bring potential new treatment options to patient care
Advance medical knowledge

Investigational drugs are approved (or rejected) for medical use through research studies. Qualified doctors, nurses, and other medical professionals are responsible for conducting each research study. Different regulatory bodies in different countries will provide this approval after a thorough review. Prescription medications in use today were first proven to be safe and effective during research studies.

About the IM014-029 Sjögren’s Study

The IM014-029 Study is a research study evaluating an oral investigational drug to see if it may reduce symptoms of Sjögren’s.

The study is for patients with primary Sjögren’s syndrome. This means that you have Sjögren’s but no other autoimmune diseases such as lupus or rheumatoid arthritis. If you have been diagnosed with primary Sjögren’s syndrome, you may want to consider taking part. During the study, you may be able to continue taking your current medication in addition to the oral investigational drug.

The study lasts approximately 32 weeks and includes about 10 visits. If you meet the criteria for the study, you will be assigned by chance to receive either the oral investigational drug or the placebo. A placebo is an inactive substance that looks like the oral investigational drug.

You may qualify to participate if you:

Are 18 (or age of majority) to 75 years old
Have been diagnosed with moderate-to-severe primary Sjögren’s
Do not have another autoimmune disease, such as lupus or rheumatoid arthritis

There may be other requirements to participate.

If you qualify and enroll you will receive:

The opportunity to potentially help advance medical knowledge about Sjögren’s and improve patient care
The oral investigational drug and study-related assessments at no cost*
Study-related monitoring by a Sjögren’s study team

*Qualified patients may receive, at no cost, study-required medical care, research medication, laboratory work, and evaluations. Patients or their insurance may be responsible for standard-of-care procedures, scans, hospital & doctor visits, and other medications to treat their disease.

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

What happens if I join the IM014-029 Sjögren’s Study?

The research study has 3 phases: Screening, Treatment, and Follow-up. There are about 10 visits over approximately 32 weeks. If you meet the criteria for the study, you will be assigned by chance to receive either the oral investigational drug or the placebo.

Frequently Asked Questions

About the Research Study

What is a research study?

A research study, also known as a clinical research study or clinical trial, is a scientific study that evaluates the safety and effectiveness of an investigational drug. A research study may show that the investigational drug is better than, as good as, or worse than the standard treatment or inactive placebo and safe or not to use within the tested doses. Qualified doctors, nurses, and other medical professionals are responsible for conducting the study.

What happens during a research study?

During a research study, you may receive the medication that is being studied (called the investigational drug), a placebo (a pill that contains no active ingredients) or another kind of medication, depending on the design of the study. If you participate, you may also have the following procedures performed to monitor your health: vital signs, blood work, physical exams, or other types of assessments that are necessary to gather the required information about the investigational drug. To ensure safety, all participants are closely monitored by a clinic staff and medical team at all times.

Who oversees research studies?

To help ensure that a research study is ethical, and that participants' rights are protected, Institutional Review Boards (IRB) or Ethics Committees (EC) review and approve research study protocols that detail all aspects of how the study is conducted. In addition, study monitors, also known as clinical research associates, visit the study clinics to confirm the study protocol procedures, and research study requirements and regulations are being followed throughout the study. Health authorities may also inspect the study clinics to ensure the safety and rights of participants in a trial and the integrity of the research study objectives are being maintained.

Are research studies safe?

The safety of study participants is the main priority of the clinic staff and medical team. All are closely monitored. Participants may experience side effects in some cases and should alert the medical team when this happens. It is through the completion of research studies that investigational drugs can be evaluated and, if proven safe and effective, approved for a particular use. Different regulatory bodies in different countries may provide this approval after a thorough review. Most prescription medications in use today were first proven to be safe and effective during research studies.

Who can participate in a research study?

Only participants who meet all required eligibility criteria for a research study 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 study. You may also be asked to provide information from your medical records to help the study team determine if you could be eligible.

Are there any risks involved in taking part in the IM014-029 Study?

You should know that your health may improve, it may stay the same, or it could get worse. When the oral investigational drug was tested in healthy volunteers, it was deemed safe to use within the tested doses. However, unexpected side effects are always a possibility. That’s why it’s important that you tell the study team if you experience anything unusual during your time on the study.

Do I have to take part in the IM014-029 Study?

No. Taking part in the IM014-029 Study is completely voluntary. Participants can leave the study at any time. If you do decide that you no longer wish to participate, we would ask you to attend a follow-up visit so that we can just check your health. This may also help us to learn more about the oral investigational drug, which could help people with Sjögren’s in the future. All of the information that study participants provide, even after stopping the investigational drug, is important for us to understand the short- and long-term effects of the study medicine.

What is informed consent?

An informed consent is a document you’ll need to sign before participating in a research study. It provides details about the study, including possible risks and benefits. It gives specific information on what you’ll need to do in order to participate and your rights as a study participant.

What is a screening process?

Everyone who volunteers for a research study undergoes a thorough screening process to determine whether he or she is eligible. Once the online questionnaire is completed, the next step in the screening process is to speak with a member of the study team, who will decide if the potential participant meets the criteria and should have a study center visit. The study center visit includes medical tests and other health assessments.

Can I participate if I’m pregnant or planning to become pregnant?

If you are a woman of childbearing potential, you must use approved birth control and agree not to donate eggs for the purpose of reproduction for 30 days before treatment, during treatment, and for 33 days after the end of the study treatment. If you are a male who is sexually active with women of childbearing potential, you must use a latex or other synthetic condom during any sexual activity and refrain from donating sperm during the research study and for 33 days after the end of study treatment. This is required even if you have had a vasectomy or if you have a female partner who is pregnant or breastfeeding.

About the Investigational Drug

What is an investigational drug?

An investigational drug is a product that has not yet been approved by appropriate regulatory authorities [(eg, the U.S. Food and Drug Administration [FDA]) for medical use.]

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 branebrutinib.

Why is the oral investigational drug being studied?

The oral investigational drug is being studied to see if it may reduce symptoms of moderate-to-severe primary Sjögren’s syndrome.

What is a placebo?

A placebo looks like the investigational drug but is an inactive substance. It is used in research studies to determine if the investigational drug is more effective than no active treatment at all. It also helps to assess the safety of the investigational drug.

Privacy, Participation, and Reimbursement

What happens to personal information?

The study team respects and protects your privacy and will not share your personally identifiable information, except as required by law. Your identity will not be revealed in any study report or publication. The study team will store your personally identifiable information with codes that do not identify you. The Informed Consent Form will provide more information about how your privacy will be maintained.

Can I withdraw from the research study after I have started?

Your participation in the research study is entirely voluntary, and you may withdraw at any time. If you decide to withdraw early from the study, you will be asked to notify the study team before doing so. You will be asked to return to the clinic at least once to complete a final visit and return any of the unused investigational drug.

Do I have to pay to participate in the research study?

There is no charge for taking part. All study-related assessments and the investigational drug are provided at no charge to you. Patients or their insurance may be responsible for standard-of-care procedures, scans, hospital & doctor visits, and other medications to treat their disease.

Does my doctor have to give his/her permission?

Your doctor does not have to give his/her permission for you to take part. However, either you or the study doctor, with your permission, may contact your personal doctor to discuss your participation before you begin and keep him/her up to date about your progress.

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