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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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Vedolizumab
  • Drug: Vedolizumab
Other Biologic Agents
  • Other: Other Biologic Agents
    Other biologic agents include: Adalimumab, Certolizumab pegol, Golimumab, and Infliximab

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.