Long-term safety of Entyvio for treating 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 G Konijeti, MD, MPH

This is an observational study to assess the long-term safety of Entyvio (vedolizumab), or other similar biologic agents in patients with Ulcerative Colitis (UC) or Crohn’s Disease (CD). Physicians will prescribe vedolizumab or other biologic agents as part of the patients’ clinical care and will collect safety information for up to 7 years.

Inclusion Criteria

Be at least 18 years of age
Be starting treatment with vedolizmnab (Entyvio) or any biologic agent for UC or CD

Exclusion Criteria

Have received any prior treatment with vedolizumab (Entyvio)
Be enrolled in another clinical trial that involves treatment for UC or CD

Additional Info

Subjects will be asked to complete 2 questionnaires to evaluate their health status at every office visit and will continue to be routinely followed-up by their physician about every 6 months.

Contact Info:

Shannon Cyhan
cyhan.shannon@scrippshealth.org