Specified Drug-Use Survey on Entyvio for IV Infusion 300 mg [Crohn's Disease]
Specified Drug-Use Survey on Vedolizumab for IV Infusion 300 mg [Crohn's Disease]
Takeda Pharmaceutical Company Limited
https://www.takeda.com/who-we-are/contact-us/
+81-6-6204-2111
smb.Japanclinicalstudydisclosure@takeda.com
Takeda Pharmaceutical Company Limited
https://www.takeda.com/who-we-are/contact-us/
+81-6-6204-2111
smb.Japanclinicalstudydisclosure@takeda.com
completed
July. 01, 2019
335
Observational
Post-marketing surveillance
treatment purpose
N/A
1. Have moderate or severe active CD
2. Have inadequate response to existing therapies
1. Patients with any contraindication for vedolizumab
No limit
No limit
Both
Crohn's disease
investigational material(s)
Generic name etc : Vedolizumab (Genetical Recombination)
INN of investigational material : Vedolizumab
Therapeutic category code : 239 Other agents affecting digestive organs
Dosage and Administration for Investigational material : Vedolizumab (Genetical Recombination) 300 milligrams (mg), intravenous (IV) infusion, at Weeks 0, 2 and 6, and every 8 weeks thereafter, for up to 54 weeks. Participants will receive IV infusion as part of routine medical care.
control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material : -
safety
Number of Participants who have One or More Adverse Events
Timeframe: Up to Week 54
Adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
safety
Number of Participants who have One or More Adverse Drug Reactions
Timeframe: Up to Week 54
Adverse drug reaction refers to AE related to administered drug.
efficacy
Change from Baseline in Crohn's Disease Activity Index (CDAI) Score
Timeframe: Baseline and after 3 doses of vedolizumab (Week 6 to 14), and Week 54 (or discontinuation of vedolizumab therapy)
CDAI is scoring system for the assessment of Crohn's Disease Activity. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease and values above 450 are seen with extremely severe disease.
efficacy
Percentage of Participants with CDAI-100 Response
Timeframe: Baseline and after 3 doses of vedolizumab (Week 6 to 14), and Week 54 (or discontinuation of vedolizumab therapy)
CDAI-100 response is defined as >=100-point decrease from baseline in the CDAI score.
efficacy
Percentage of Participants with CDAI-70 Response
Timeframe: Baseline and after 3 doses of vedolizumab (Week 6 to 14), and Week 54 (or discontinuation of vedolizumab therapy)
CDAI-70 response is defined as >=70-point decrease from baseline in the CDAI score.
efficacy
Percentage of Participants with Clinical Remission
Timeframe: Baseline and after 3 doses of vedolizumab (Week 6 to 14), and Week 54 (or discontinuation of vedolizumab therapy)
Clinical remission is defined as CDAI score of =<150 points.
efficacy
Change from Baseline in Quality of Life (QOL) Assessment using Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
Timeframe: Baseline and after 3 doses of vedolizumab (Week 6 to 14), and Week 54 (or discontinuation of vedolizumab therapy)
The SIBDQ 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 total score will be reported and is ranging from 10 to 70 with a higher score indicates a better health-related quality of life.
efficacy
Change from Baseline in White Blood Cell Count
Timeframe: Baseline and up to Week 54
efficacy
Change from Baseline in Lymphocytes
Timeframe: Baseline and up to Week 54
efficacy
Change from Baseline in Hemoglobin
Timeframe: Baseline and up to Week 54
efficacy
Change from Baseline in Hematocrit
Timeframe: Baseline and up to Week 54
efficacy
Change from Baseline in Albumin
Timeframe: Baseline and up to Week 54
efficacy
Change from Baseline in Albumin
Timeframe: Baseline and up to Week 54
Takeda Pharmaceutical Company Limited
-
-
-
Not applicable due to post-marketing surveillance.
