Entyvio (vedolizumab) long-term safety study: An international observational prospective cohort study comparing vedolizumab to other biologic agents in patients with ulcerative colitis or Crohn's Disease

COVID-19 update:

In response to the COVID pandemic, Scripps Health has temporarily suspended enrollment for all clinical trials. Exceptions will exist for trials with curative intent, life-saving treatment or when no standard of care exists. For questions, please call Scripps Office for the Protection of Research Subjects at 858-678-6402.

Trial ID:
IRB-16-6868
Gauree Konijeti
The purpose of this study is to assess the long-term safety of vedolizumab versus other biologic agents in participants with Ulcerative Colitis (UC) or Crohn's Disease (CD).

Inclusion Criteria:

  • 1. Signed informed consent, by the participant or a legally acceptable representative.
  • 2. Aged at least 18 years.
  • 3. Initiating vedolizumab or another biologic agent for UC or CD.
  • 4. Signed release form, by the participant or a legally acceptable representative, permitting abstraction of the participant's medical records at Baseline and during participation in the study.

Exclusion Criteria:

  • 1. The participant is enrolled in a clinical trial in which treatment for CD or UC is managed through a protocol.
  • 2. Prior treatment with vedolizumab.
  • 3. Any other reason that, in the Investigator's opinion, makes the participant unsuitable to participate in this study.

Why isn't this trial accepting new patients?

The trial may have a limited enrollment number, reached its maximum, or come to the end of its enrollment period. View trials that are recruiting

How else can Scripps help me?

We have a broad range of physician expertise and specialized medical services available. You can find a doctor online, call 1-800-SCRIPPS (1-800-727-4777) for personal help, or see related Scripps services.

How can I find trials that are accepting new participants?

For more information, see a list of trials that are recruiting, or call the clinical research office at 858-648-6402 for help.