Expired Study
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Clinical Trial 40086

New York, NY 10029

Study Summary:

EXPLORER is a clinical research study for patients with Crohn’s disease

The EXPLORER study is now enrolling newly diagnosed patients with Crohn’s disease (CD) who are at higher risk of disease-related complications. While there are many therapies available to treat CD, some are not successful in healing the damage the condition can do to the digestive tract, or in relieving symptoms, especially in those with more severe forms of the disease.

What is the Explorer study?
Explorer is a clinical research study designed to investigate the safety and efficacy of a combination of drugs The 3 drugs—vedolizumab, adalimumab, and methotrexate—are all FDA-approved. The use of these drugs in this study is investigational.

The main goal is to see if the study drugs work together to treat the inflammation CD can cause, as well as prevent future damage. Crohn’s is a complicated condition that causes ongoing irritation of the digestive tract, including the lining of the stomach. In more severe cases, the damage CD causes can lead to a need for immediate medical attention, including hospitalization and surgery. The EXPLORER study will also evaluate if the combination of study drugs can prevent these kinds of complications.

By participating in the Explorer you will receive study-related medical care from an experienced study team. Those who qualify for this study will receive study-related medical care at no cost to them.

Who is eligible for this clinical research study?
Participants may be allowed to enter into the study if they:

  • Are between 18 and 65 years of age at the time of screening for the study
  • Have been diagnosed with CD in the past 24 months
  • Currently have moderate-to-severe active CD*
  • Have CD that affects certain parts of their digestive tract*
  • Are able and willing to comply with the study visit schedule and instructions they are given
There are additional criteria for inclusion within this clinical study, which the study doctor will discuss with you, should you choose to participate.

Why should I consider participating?
By participating in the EXPLORER study, you or your family member are helping to advance the understanding of CD and assisting with the potential approval of a new treatment option. The information gathered (including blood sampling and the other tests completed) may, in the future, help others who have CD.

If you or a family member was newly diagnosed with moderate-to-severe CD you may be interested in finding out more about this new research study.

Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.