Crohn's Disease
Conditions
Brief summary
The purpose of this survey is to evaluate the long-term safety and effectiveness of vedolizumab for intravenous (IV) infusion 300 milligrams (mg) in Crohn's disease (CD) patients in the routine clinical setting.
Detailed description
The drug being tested in this survey is called vedolizumab for IV infusion 300 mg. This drug is being tested to treat patients who have CD. This survey is an observational (non-interventional) study and will look at the long-term safety and effectiveness of vedolizumab for IV infusion 300 mg in the routine clinical setting. The planned number of observed patients will be approximately 300. This multi-center observational trial will be conducted in Japan.
Interventions
DRUGVedolizumab (Genetical Recombination)
Vedolizumab IV infusion
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Have moderate or severe active CD 2. Have inadequate response to existing therapies
Exclusion criteria
Patients with any contraindication for vedolizumab
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants who have One or More Adverse Events | 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. |
| Number of Participants who have One or More Adverse Drug Reactions | Up to Week 54 | 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. Adverse drug reaction refers to AE related to administered drug. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Crohn's Disease Activity Index (CDAI) Score | 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. |
| Percentage of Participants with CDAI-100 Response | 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. 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. |
| Percentage of Participants with CDAI-70 Response | 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. 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. |
| Percentage of Participants with Clinical Remission | 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. 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. |
| Change from Baseline in Quality of Life (QOL) Assessment using Short Inflammatory Bowel Disease Questionnaire (SIBDQ) | 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. |
| Change from Baseline in White Blood Cell Count | Baseline and up to Week 54 | — |
| Change from Baseline in Lymphocytes | Baseline and up to Week 54 | — |
| Change from Baseline in Hemoglobin | Baseline and up to Week 54 | — |
| Change from Baseline in Hematocrit | Baseline and up to Week 54 | — |
| Change from Baseline in Albumin | Baseline and up to Week 54 | — |
| Change from Baseline in C-reactive protein (CRP) | Baseline and up to Week 54 | — |
Countries
Japan
Contacts
STUDY_DIRECTORStudy Director
Takeda
Outcome results
None listed