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Specified Drug-Use Survey on Vedolizumab for IV Infusion 300 mg [Crohn's Disease]

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ClinicalTrials.gov Identifier: NCT04002180
Recruitment Status : Recruiting
First Posted : June 28, 2019
Last Update Posted : July 22, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda

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.

Condition or disease Intervention/treatment
Crohn's Disease Drug: Vedolizumab (Genetical Recombination)

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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Specified Drug-Use Survey on Entyvio for IV Infusion 300 mg [Crohn's Disease]
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : October 31, 2023
Estimated Study Completion Date : October 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Vedolizumab

Group/Cohort Intervention/treatment
Vedolizumab 300 mg
Vedolizumab (Genetical Recombination) 300 mg, 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.
Drug: Vedolizumab (Genetical Recombination)
Vedolizumab IV infusion
Other Name: Entyvio for IV Infusion 300 mg




Primary Outcome Measures :
  1. Number of Participants who have One or More Adverse Events [ Time Frame: 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.

  2. Number of Participants who have One or More Adverse Drug Reactions [ Time Frame: 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 Outcome Measures :
  1. Change from Baseline in Crohn's Disease Activity Index (CDAI) Score [ Time Frame: 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.

  2. Percentage of Participants with CDAI-100 Response [ Time Frame: 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.

  3. Percentage of Participants with CDAI-70 Response [ Time Frame: 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.

  4. Percentage of Participants with Clinical Remission [ Time Frame: 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.

  5. Change from Baseline in Quality of Life (QOL) Assessment using Short Inflammatory Bowel Disease Questionnaire (SIBDQ) [ Time Frame: 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.

  6. Change from Baseline in White Blood Cell Count [ Time Frame: Baseline and up to Week 54 ]
  7. Change from Baseline in Lymphocytes [ Time Frame: Baseline and up to Week 54 ]
  8. Change from Baseline in Hemoglobin [ Time Frame: Baseline and up to Week 54 ]
  9. Change from Baseline in Hematocrit [ Time Frame: Baseline and up to Week 54 ]
  10. Change from Baseline in Albumin [ Time Frame: Baseline and up to Week 54 ]
  11. Change from Baseline in C-reactive protein (CRP) [ Time Frame: Baseline and up to Week 54 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
CD patients treated with vedolizumab for IV infusion 300 mg as part of routine medical care
Criteria

Inclusion Criteria:

  1. Have moderate or severe active CD
  2. Have inadequate response to existing therapies

Exclusion Criteria:

Patients with any contraindication for vedolizumab


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): NCT04002180


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

Locations
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Japan
Takeda Selected Site Recruiting
Tokyo, Japan
Sponsors and Collaborators
Takeda
Investigators
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Study Director: Study Director Takeda
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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT04002180    
Other Study ID Numbers: Vedolizumab-4021
JapicCTI-194830 ( Registry Identifier: JapicCTI )
First Posted: June 28, 2019    Key Record Dates
Last Update Posted: July 22, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Vedolizumab
Gastrointestinal Agents