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.
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:
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.
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:
There may be other requirements to participate.
If you qualify and enroll you will receive:
*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.
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.
What is a research study?
What happens during a research study?
Who oversees research studies?
Are research studies safe?
Who can participate in a research study?
Are there any risks involved in taking part in the IM014-029 Study?
Do I have to take part in the IM014-029 Study?
What is informed consent?
What is a screening process?
Can I participate if I’m pregnant or planning to become pregnant?
What is an investigational drug?
What is the name of the investigational drug?
Why is the oral investigational drug being studied?
What happens to personal information?
Can I withdraw from the research study after I have started?
Do I have to pay to participate in the research study?
Does my doctor have to give his/her permission?