EXPLORER is a clinical research study designed to learn if a combination of 3 FDA-approved drugs—vedolizumab, adalimumab, and methotrexate—work when taken together in newly diagnosed patients who may be at a higher risk of disease related complications. The use of these drugs in this study is investigational.See if you qualify →
Crohn’s disease belongs to a group of conditions known as Inflammatory Bowel Diseases (IBD). Crohn’s disease is considered a "chronic inflammatory" condition because it can cause periods of ongoing irritation of the digestive tract that directly cause symptoms, also called "flare-ups." These can be followed by periods of time when symptoms are not noticeable, also called "remission."
Approximately 780,000 people in the United States are affected by Crohn’s disease (CD). Women are slightly more likely to get CD than men. CD can occur at any age, but, diagnosis happens most to those between 15 and 35. It also appears that Crohn’s is growing more common in children and adults, and that being hospitalized due to Crohn’s is increasing.
EXPLORER is a long-term clinical research study, which means the total amount of time you may be involved in the study is up to 132 weeks. It is also considered "open-label," which means both the study doctor and participants are aware of the medication being given.
The main goal of the study is to see if the combination of study drugs works on treating inflammation due to Crohn’s and future damage to the digestive system. Over time, Crohn’s is a progressive disease that can ultimately lead to irreversible fibrosis, scarring, and damage of the GI tract that can result in surgery for the majority of patients. The EXPLORER study will evaluate if the combination therapy can have an impact on these complications.
Participants may be eligible if they:
* The study doctor will discuss additional criteria for this clinical research study should you choose to participate.
If eligible, you or your family member may participate in the open-label study. During this time, you will make regular visits to the study clinic (following the screening period). The EXPLORER clinical research study is a long-term* clinical research study that includes the screening period, which may be up to 4 weeks, followed by:
You can expect to visit the clinic approximately 20 times over the 124-week period, depending on the scheduling of your study procedures.
*Total time of study involvement may be up to 132 weeks.