Entyvio (Vedolizumab) Long Term Safety Study

Study Overview
=================
Brief Summary
-----------------
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).

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.

Official Title
-----------------
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

Conditions
-----------------
Ulcerative Colitis and Crohn's Disease

Intervention / Treatment
-----------------
* Drug: Vedolizumab
* Other: Other Biologic Agents


Participation Criteria
=================
Eligibility Criteria
-----------------
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 UC or CD. 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. Prior treatment with vedolizumab. Any other reason that, in the Investigator's opinion, makes the participant unsuitable to participate in this study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vedolizumab<br> | Drug: Vedolizumab<br> <br> |
| Other Biologic Agents<br> | Other: Other Biologic Agents<br>* Other biologic agents include: Adalimumab, Certolizumab pegol, Golimumab, and Infliximab<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with Adverse Events of Special Interest | Adverse events of special interest in this study includes serious and opportunistic infections, gastrointestinal infections, respiratory infections, other clinically significant infections: malignancies; infusion-related reactions and hypersensitivity, hepatic injury; psoriasis and other skin events, other SAEs and adverse reactions. | 7 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Severity in Ulcerative Colitis (UC) Participants | Disease severity will be measured using the Mayo score for ulcerative colitis and is ranged from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores: stool frequency, rectal bleeding and physician rating of disease activity, each ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). | Baseline and at every 6 months (up to 7 years) | 
| Disease Severity in Crohn's Disease (CD) Participants | Disease severity will be measured using the Harvey-Bradshaw Index (HBI) for crohn's disease. HBI is used in the assessment and quantification of symptoms and the present level of disease activity of participants with Crohn's disease. It is a validated clinical index for Crohn's disease,HBI score consists of clinical parameters of general well-being (0= very well 1=slightly below average, 2=poor, 3=very poor, 4=terrible); abdominal pain (0=none, 1=mild, 2=moderate, 3=severe); number of liquid stools per day; abdominal mass (0=none, 1=dubious, 2=definite, 3=tender); and complications (8 items: arthralgia, uveitis, erythema nodosum, aphthous ulcers, pyoderma gangrenosum, anal fissures, new fistula, abscess [score 1 per item]).Lower scores indicate better well-being. The scores are classified as: <5=remission, 5-7=mild disease, 8-16=moderate disease and >16=severe disease. Minimum score is 0 and no pre-specified maximum score as it depends on the number of liquid stools. | Baseline and at every 6 months (up to 7 years) | 
| Participant Reported Quality of Life Assessment Using Short Inflammatory Bowel Disease Questionnaire (SIBDQ) | The Short IBD Questionnaire is an instrument used to assess quality of life and is a disease-specific health-related quality of life questionnaire, that consists of 10 questions, each question is scored on a scale from 1 (poor quality of life) to 7 (good quality of life). The scores are summed up and divided by 10 for a mean score ranging from 1 (poor quality of life) to 7 (good quality of life). A higher score indicates a better health-related quality of life. | Baseline and at every 6 months (up to 7 years) | 
| Participant Reported Quality of Life Assessment Using 12-Item Short Form Health Survey (SF-12) | The SF-12 health questionnaire is a 12 question assessment of functional health and well-being. The survey asks about various health aspects, including physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health (psychological distress and psychological well-being). Two summary measures are derived: the Physical and the Mental Health Component Summary. For each component summary, survey items were weighted and summed to create a summary score between 0 and 100 with higher score indicating better quality of life. | Baseline and at every 6 months (up to 7 years) | 
| Time to Treatment Discontinuation | Time to discontinuation for Entyvio and the other biologic agents will be measured. | Baseline and at every 6 months (up to 7 years) | 
| Reasons for Treatment Discontinuation | Reasons for discontinuations for Entyvio and the other biologic agents will be measured. | Baseline and at every 6 months (up to 7 years) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Drug therapy