Entyvio (Vedolizumab) Long Term Safety Study
Purpose
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).
Condition
- Ulcerative Colitis and Crohn's Disease
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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.
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Vedolizumab |
|
|
Other Biologic Agents |
|
More Details
- Status
- Completed
- Sponsor
- Takeda
Study Contact
Detailed Description
The drug being tested in this prospective, observational study is called vedolizumab. Vedolizumab is being used to treat people who have UC or CD. This study will look at the long-term safety of vedolizumab versus other biologic agents in participants with UC or CD. The study will enroll approximately 5000 participants. All participants enrolled in this will belong to one of the two treatment group: - Vedolizumab - Other Biologic Agents -adalimumab, certolizumab pegol. Golimumab and infliximab. Study drugs will be prescribed by the physician according to local prescribing information in the participating countries. This multi-centre trial will be conducted worldwide. The overall time to participate in this study is 7 years. Participants will make visits at every 6 months to their treating physician.