FAQs
Participating in a clinical study is different from receiving standard medical care, which is intended to treat a condition or disease. The purpose of a clinical study is to collect information about an investigational treatment.
If you participate in a clinical study, you will be evaluated by study doctors and nurses on a regular basis during your participation.
Using the information collected in clinical studies, regulatory health agencies can determine if an investigational treatment could one day be made available to the public.
By participating in the BLOOM clinical study, you could help advance research for Sjogren’s Disease.
The purpose of the BLOOM clinical study is to see if a study medication is safe and helps people with Sjogren’s Disease.
Click on the button to take a pre-screener and see if you qualify.
Around 180 people will take part in this clinical study.
- Follow all instructions from the study doctor and staff
- Answer questions about your health to the best of your knowledge
- Come to all scheduled study clinic visits
- Complete all clinical study questionnaires/rating scales
- Complete your dosing diary every time you receive or administer injections of the study Tell the study doctor or staff about any changes in your health, medications, or the way you feel
- Tell the study doctor or staff about any new medications or therapies you are taking
- Continue making regular visits to your family/personal doctor or any other specialists
- Follow the birth control requirements described in the informed consent form (ICF)
- Tell the study doctor or staff if you or your partner becomes pregnant during the study
- Do not participate in any other research studies while you are in this study
- Tell the study doctor or staff about any medical care you receive outside this study
If you visit an emergency room or receive any other medical care outside this study, please tell the healthcare professionals treating you that you are participating in this study. This information will help them better care for you.
It is not known if receiving investigational treatment will improve your health. It is possible that your health may benefit from investigational treatment. However, you may receive little or no benefit from study treatment, and your Sjogren’s Disease may get worse.
The information that doctors and researchers learn in this study will help improve what they know about treatments for Sjogren’s Disease and may help people with Sjogren’s Disease in the future.
Prior to you joining the study, you will receive an Informed Consent Form (ICF). The study doctor and study staff will discuss with you the potential risks, benefits, and side effects related to this study, as well as answer any questions you may have. Throughout your study participation, your health will be closely monitored for any signs of side effects.
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