About the Study
The VIVID-1 clinical research study is looking for participants to determine the safety and effectiveness of an investigational drug in people with moderate to severe active Crohn’s Disease. You may be eligible to participate in this study if you are:
- 18 to 80 years of age
- diagnosed with Crohn’s disease for at least three months
There are additional criteria that are included in the questionnaire on this website (www.vivid1study.com) and some that are reviewed by the team at the study center at the first visit.
The study will also involve visiting the study doctor or clinical research staff up to 19 times over approximately 17 months and receiving 3 endoscopies to determine if the investigational drug is working.
This initial appointment is an opportunity for you to:
- Learn more about the VIVID-1. You’ll be speaking with a study coordinator at the study center to learn more regarding your participation in this study.
- Ask any important questions you may have. These can be any questions you may have about this study or clinical research in general.
- Determine if the VIVID-1 study may be right for you. After speaking with the study coordinator and learning details about this study, the research staff will perform a series of screening tests to determine if you are eligible to participate. If you’re eligible, you will be given an opportunity to decide if participation is right for you. If you agree to take part, the center will ask you to review and sign a consent form.
If eligible, you will be in the study for approximately 17 months and visit the study doctor or clinical research staff up to 19 times. The study coordinator can answer any questions you have about the VIVID-1 study.
Participants will be required to visit the study doctor or clinical research staff up to 19 times.
If you qualify for the VIVID-1 study, you will be randomly assigned to one of three treatment groups. You will have a 6 in 11 (about 54%) chance of receiving the investigational drug, a 3 in 11 (about 27%) chance of receiving an approved medicine for Crohn’s disease, and a 2 in 11 (about 18%) chance of receiving the placebo. Neither you nor the study team will know which treatment group you are assigned.
Do not discontinue any medication unless you are advised to do so by the study center staff or your primary care physician.
The study centers are located throughout North America.
There may be no cost to you or your insurance provider for participating in the study. Qualified participants may receive study-required medical care and study drug at no cost. The study will not pay for other medical care or current medication(s) needed to support your daily health care routine.
No, health insurance is not needed in order to participate.
Research studies are designed in specific ways to test the investigational drug for safety and effectiveness. One or more of the answers that you provided were outside of the guidelines for this study. This does not mean you will not qualify for different research studies.
About Clinical Research
A clinical trial, also called a clinical research study, is a carefully designed scientific evaluation of an investigational drug or treatment. Clinical trials are conducted by doctors and researchers.
Clinical research helps doctors and scientists determine if an investigational drug or therapies are safe and/or effective for use in humans to potentially treat a condition, disease or disorder. Clinical studies often require a large number of volunteers to participate in a single study, sometimes thousands are needed to obtain reliable information.
One way to find information about clinical trials is by searching this website: www.clinicaltrials.gov. ClinicalTrials.gov is an interactive online database, managed by the National Library of Medicine. It provides information about both federally and privately supported clinical research. ClinicalTrials.gov is updated regularly and offers information on each trial’s purpose, who is eligible to participate, locations, and phone numbers to call for more information.
For those who are eligible, taking part in research studies offers several benefits:
- Getting actively involved in their own health care
- Having access to potentially new research treatments
- Having access to expert medical care for the condition being studied, since investigators are often specialists in the disease area being studied
- Helping others by contributing to medical research
It is important to test drugs and medical products in the people they are meant to help. It is also important to conduct research in a variety of people because different people may respond differently to treatments.
For each research study, researchers develop eligibility criteria, such as age, gender, previous treatment history, and other medical conditions. Not everyone who applies for a research study will be accepted. Volunteers may be excluded based on the eligibility criteria and/or the number of participants needed by the researchers.
Research studies can be sponsored by an organization such as a pharmaceutical company, a federal agency such as the Veterans Administration, or an individual, such as a physician or health care provider. The sponsor determines the location(s) of the trials, which are usually conducted at universities, medical centers, clinics, doctor’s offices, and/or at hospitals.
“Informed Consent” is a process of information exchange before an adult agrees to participate in research. Potential research participants will be asked to read and sign an informed consent document, but will also be given instructions, verbally and in writing, question/answer sessions and other reading materials to assure the potential study participants understanding and willingness to voluntarily enroll in the research.
Before you agree to volunteer for the study, the study doctor or staff is required to explain all the details of the study, which will include the risks and benefits, and address your questions. After all of your questions have been answered, and if you wish to participate, then you will sign a document called the informed consent form to ensure:
- You agree to volunteer
- You understand the study, including the study procedures, risks and potential side effects of the investigational drug
- You understand that you can leave the study at any time, for any reason
If you don’t understand what is expected of you or the document, you should continue to ask questions and talk with the study doctor, your family or others that you trust, until you feel you understand.