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).
Brief Title
Entyvio (Vedolizumab) Long Term Safety Study
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.
* 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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Ulcerative Colitis and Crohn's Disease
Eligibility 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.
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.
Inclusion 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.
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.
Gender
All
Gender Based
false
Keywords
Drug therapy
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT02674308
Org Class
Industry
Org Full Name
Takeda
Org Study Id
MLN-0002_401
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
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
Primary Outcomes
Outcome Description
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.
Outcome Measure
Percentage of Participants with Adverse Events of Special Interest
Outcome Time Frame
7 years
Secondary Ids
Secondary Id
MLN0002-401
Secondary Outcomes
Outcome Description
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).
Outcome Time Frame
Baseline and at every 6 months (up to 7 years)
Outcome Measure
Disease Severity in Ulcerative Colitis (UC) Participants
Outcome Description
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.
Outcome Time Frame
Baseline and at every 6 months (up to 7 years)
Outcome Measure
Disease Severity in Crohn's Disease (CD) Participants
Outcome Description
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.
Outcome Time Frame
Baseline and at every 6 months (up to 7 years)
Outcome Measure
Participant Reported Quality of Life Assessment Using Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
Outcome Description
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.
Outcome Time Frame
Baseline and at every 6 months (up to 7 years)
Outcome Measure
Participant Reported Quality of Life Assessment Using 12-Item Short Form Health Survey (SF-12)
Outcome Description
Time to discontinuation for Entyvio and the other biologic agents will be measured.
Outcome Time Frame
Baseline and at every 6 months (up to 7 years)
Outcome Measure
Time to Treatment Discontinuation
Outcome Description
Reasons for discontinuations for Entyvio and the other biologic agents will be measured.
Outcome Time Frame
Baseline and at every 6 months (up to 7 years)
Outcome Measure
Reasons for Treatment Discontinuation
See Also Links
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
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
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Dana Lukin
Investigator Email
dlukin@montefiore.org
Investigator Phone
917-769-8594
Categories Mesh Debug
Digestive System --- COLITIS, ULCERATIVE
Digestive System --- CROHN DISEASE
Digestive System --- COLITIS
Digestive System --- GASTROENTERITIS
Gastrointestinal (GI) Cancers --- GASTROINTESTINAL DISEASES
Digestive System --- GASTROINTESTINAL DISEASES
Gastrointestinal (GI) Cancers --- DIGESTIVE SYSTEM DISEASES
Digestive System --- DIGESTIVE SYSTEM DISEASES
Liver --- DIGESTIVE SYSTEM DISEASES
Digestive System --- INFLAMMATORY BOWEL DISEASES
Gastrointestinal (GI) Cancers --- COLONIC DISEASES
Digestive System --- COLONIC DISEASES
Gastrointestinal (GI) Cancers --- INTESTINAL DISEASES
Digestive System --- INTESTINAL DISEASES
MeSH Terms
COLITIS, ULCERATIVE
CROHN DISEASE
COLITIS
GASTROENTERITIS
GASTROINTESTINAL DISEASES
DIGESTIVE SYSTEM DISEASES
INFLAMMATORY BOWEL DISEASES
COLONIC DISEASES
INTESTINAL DISEASES
VEDOLIZUMAB