Entyvio (Vedolizumab) Long Term Safety Study (Entyvio PASS)
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|ClinicalTrials.gov Identifier: NCT02674308|
Recruitment Status : Recruiting
First Posted : February 4, 2016
Last Update Posted : August 1, 2018
|Condition or disease||Intervention/treatment|
|Ulcerative Colitis and Crohn's Disease||Drug: Vedolizumab Other: Other Biologic Agents|
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:
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||5000 participants|
|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|
|Actual Study Start Date :||March 31, 2015|
|Estimated Primary Completion Date :||July 1, 2021|
|Estimated Study Completion Date :||June 30, 2022|
|Other Biologic Agents||
Other: Other Biologic Agents
Other biologic agents include: Adalimumab, Certolizumab pegol, Golimumab, and Infliximab
- Percentage of Participants with Adverse Events of Special Interest [ Time Frame: 7 years ]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.
- Disease Severity in Ulcerative Colitis (UC) Participants [ Time Frame: Baseline and at every 6 months (up to 7 years) ]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).
- Disease Severity in Crohn's Disease (CD) Participants [ Time Frame: Baseline and at every 6 months (up to 7 years) ]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.
- Participant Reported Quality of Life Assessment Using Short Inflammatory Bowel Disease Questionnaire (SIBDQ) [ Time Frame: Baseline and at every 6 months (up to 7 years) ]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.
- Participant Reported Quality of Life Assessment Using 12-Item Short Form Health Survey (SF-12) [ Time Frame: Baseline and at every 6 months (up to 7 years) ]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.
- Time to Treatment Discontinuation [ Time Frame: Baseline and at every 6 months (up to 7 years) ]Time to discontinuation for Entyvio and the other biologic agents will be measured.
- Reasons for Treatment Discontinuation [ Time Frame: Baseline and at every 6 months (up to 7 years) ]Reasons for discontinuations for Entyvio and the other biologic agents will be measured.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02674308
|Contact: Takeda Study Registration Call Centerfirstname.lastname@example.org|
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|Study Director:||Medical Director||Takeda|