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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
Sponsor:
Information provided by (Responsible Party):
Takeda

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).

Condition or disease Intervention/treatment
Ulcerative Colitis and Crohn's Disease Drug: Vedolizumab Other: Other Biologic Agents

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.


Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Drug Information available for: Vedolizumab

Group/Cohort Intervention/treatment
Vedolizumab Drug: Vedolizumab
Other Biologic Agents Other: Other Biologic Agents
Other biologic agents include: Adalimumab, Certolizumab pegol, Golimumab, and Infliximab




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants with ulcerative colitis (UC) or Crohn's disease (CD) who are initiating Entyvio or another biologic agent. Participants may be biologic-naive or have prior use of a biologic agent
Criteria

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.

Information from the National Library of Medicine

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


Contacts
Contact: Takeda Study Registration Call Center +1-877-825-3327 medicalinformation@tpna.com

  Show 287 Study Locations
Sponsors and Collaborators
Takeda
Investigators
Study Director: Medical Director Takeda

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02674308     History of Changes
Other Study ID Numbers: MLN-0002_401
First Posted: February 4, 2016    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018

Keywords provided by Takeda:
Drug therapy

Additional relevant MeSH terms:
Crohn Disease
Colitis
Ulcer
Colitis, Ulcerative
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colonic Diseases
Pathologic Processes
Vedolizumab
Gastrointestinal Agents