A Study Comparing the Long Term Safety of Entyvio (Vedolizumab) to Other Biologic Agents in Patients with Ulcerative Colitis or Crohn's Disease
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 15-008869
NCT ID: NCT02674308
Sponsor Protocol Number: MLN-0002_401
About this study
The purpose of this study is to assess the long-term safety of vedolizumab versus other biologic agents in participants with Ulcerative Colitis or Crohn's Disease.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- Signed informed consent, by the participant or a legally acceptable representative
- Aged at least 18 years
- Initiating vedolizumab or another biologic agent for ulcerative colitis or crohn's disease
- 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
- Enrolled in a clinical trial in which treatment for crohn's disease or ulcerative colitis is managed through a protocol
- Prior treatment with vedolizumab
- Any reason that, in the Investigator's opinion, makes the participant unsuitable to participate in this study
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Edward Loftus, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available