Clinical research studies are conducted to determine if potential new drugs are safe and whether they work. Clinical research studies are performed according to government regulations that help protect the safety and rights of study participants.
A clinical investigator is a medical researcher in charge of conducting a clinical study and ensuring the well-being of study volunteers. The investigators conducting the DIVERSITY1 study are all qualified licensed doctors and medical specialists.
An investigational drug, or research study drug, is a drug that has not yet been approved by Health Canada, the Food and Drug Administration (FDA), the European Medicines Agency (EMA), or other regulatory agencies for prescription by doctors. The investigational drug in the DIVERSITY1 study is filgotinib.
Yes, participation in any clinical research study is completely voluntary. If you decide to stop participating at any time, your exit will not affect the medical care you would otherwise receive.
Informed consent is the process of learning the key facts and details about a clinical research study. This information will be provided to you before you decide to participate and as new information becomes available during your continued participation throughout the study. Once you have read the informed consent form and understand the details, including the risks and benefits, you can decide whether to sign the document. The informed consent process also includes opportunities for you to ask questions about the study. No study-related procedures will take place without a signed informed consent form.
Information about your personal health will be kept private and confidential. With your permission, the medical history and health condition information you provide via the prescreening form on this website will be transferred to the study doctor’s office. A representative from the study doctor’s office will contact you to further determine your interest and eligibility. Your personal information will not be disclosed to anyone outside of this clinical research study group without your consent, unless disclosure is required by law or regulations of the FDA, the EMA, or similar agencies in other countries.
After answering the questions in the prescreening form, you will have the option to be notified about future clinical studies for Crohn’s disease. Respondents who do not qualify for the DIVERSITY1 study or who are unable to locate a convenient site will also be able to opt in for updates. If you opt in to receive these updates, you may receive emails from us in the future and may unsubscribe at any time.
This clinical study is being conducted to find out whether filgotinib, the investigational drug, is effective in treating the signs and symptoms of Crohn’s disease.
Your answers to the questions in the online prescreening form will determine if you meet certain key criteria that are required to participate in the DIVERSITY1 study. If you meet these criteria, you may then provide your contact information to the participating doctor’s office of your choice via our website. Their staff will answer any questions you may have and will discuss the next steps to further determine whether you meet all of the criteria for participation. Not all people who complete the online prescreening form will be able to participate in this study.
If you meet the criteria in the prescreening form, the staff at the doctor’s office will ask you to review and sign an informed consent form that explains more about the study. Then the staff at the doctor’s office will ask more questions and run some medical tests to see if you meet all eligibility criteria to participate in the clinical research study.
If you qualify for the DIVERSITY1 study, you will go to the study doctor’s office for periodic visits for study exams to evaluate your general health and to discuss your Crohn’s disease.
Feel free to discuss your study-related medical care with the study doctor or staff at any time during the course of the research study. It is important to take the investigational study drug as prescribed. You will answer questions regarding how you feel during your participation and whether the investigational study drug has been taken at the appropriate times. Participants are encouraged to discuss study participation with their general practitioner.
The study consists of 14 to 21 visits. The visits are one to eight weeks apart, over a period of approximately 58 weeks (about one year).
Approximately 1,320 people worldwide will be enrolled in the DIVERSITY1 study. This study is looking for people who have moderate to severe active Crohn’s disease.
Reimbursement for study-related travel may be available depending on local practice in your country.
If you participate, study-related doctors’ visits, monitoring of your condition, and the study drug will be provided to you at no cost. You do not need health insurance to participate. Other drugs you may be taking for your Crohn’s disease will not be paid for. The study staff at the participating site will be able to answer any questions you may have.
The choice to participate in this study is entirely yours. Your primary care doctor does not have to give his or her permission or a referral for you to participate in this study. However, you should tell your primary care physician about your participation and keep him or her informed about the study. You should also keep the study doctor informed if your primary care physician changes your Crohn's disease treatment or if there are other changes to your health during the study.
A long-term extension study is a clinical study that allows participants to continue on the study drug after they have finished their participation in the original study. After completion of DIVERSITY1, participants may have the opportunity to enroll in a long-term extension study of filgotinib in the treatment of Crohn’s disease.
The study drug, filgotinib, is a JAK1 inhibitor. JAK1 is a protein inside certain cells, including immune cells, that stimulates their activity. When immune cells are overactive, they can cause inflammation and trigger symptoms such as abdominal pain, diarrhea, and bloody stools. The DIVERSITY1 study will help determine whether filgotinib improves the signs and symptoms of Crohn’s disease.
A placebo looks the same as the study drug but does not contain any active ingredients. The use of a placebo is important in clinical research studies because it allows researchers to determine how well the active study drug is working.
Some people who participate in the DIVERSITY1 study will receive active investigational drug (filgotinib) and some will receive a placebo. Neither you nor the study doctor will be able to choose or know which study group you are in. However, the study doctor can access this information if there is an emergency or if it is necessary to know for your health.
You could experience side effects associated with the study drug. The study staff will discuss the known risks in detail with you before you decide whether to participate.
After a clinical study is complete, all of the information is collected and analyzed to help determine the study drug’s safety and efficacy. Please consult with your study doctor or primary healthcare provider to determine your treatment options after completing the study.
The DIVERSITY1 study is being conducted by trained, qualified, and licensed medical doctors worldwide.
Gilead Sciences, Inc. and Galapagos NV are developing the DIVERSITY1 study drug and sponsoring this clinical research study. GILEAD is a trademark of Gilead Sciences, Inc. All other trademarks referenced in this document are the property of their respective owners.