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Completed

NCT Number: NCT04002180

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

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.

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Takeda Selected Site

Tokyo, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Have moderate or severe active CD
  • Have inadequate response to existing therapies

Exclusion criteria

Patients with any contraindication for vedolizumab

Treatment and study plan

Vedolizumab (Genetical Recombination)

Drug

Vedolizumab IV infusion

Other names: Entyvio for IV Infusion 300 mg

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Jun 28, 2019
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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