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| ID | Type | Description | Link |
|---|---|---|---|
| jRCT1080224534 | Registry Identifier | jRCT |
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The purpose of this survey is to evaluate the long-term safety and effectiveness of vedolizumab for intravenous (IV) infusion 300 milligrams (mg) in ulcerative colitis (UC) patients in the routine clinical setting.
The drug being tested in this study is called vedolizumab for IV infusion 300 mg. This drug is being tested to treat patients who have UC.
This study 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 1,000.
This multi-center observational trial will be conducted in Japan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vedolizumab 300 mg | Vedolizumab IV infusion 300 mg, 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vedolizumab | Drug | Vedolizumab IV infusion |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experienced at Least One Adverse Events (AEs) | An adverse event (AE) is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not the event is considered causally related to the use of the product. | Up to Week 54 |
| Number of Participants Who Experienced at Least One Adverse Drug Reactions | An adverse event (AE) is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not the event is considered causally related to the use of the product. Adverse drug reaction refers to AE related to administered drug. | Up to Week 54 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Had a Presence or Absence of Therapeutic Response After 3 Doses of Vedolizumab | Week 54 | |
| Number of Participants Who Continued the Therapy After 3 Doses of Vedolizumab | Week 54 |
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Inclusion Criteria:
Exclusion Criteria:
Patients with any contraindication for vedolizumab
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UC patients treated with vedolizumab for IV infusion 300 mg as part of routine medical care
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Takeda Selected Site | Tokyo | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37140705 | Derived | Matsuoka K, Hisamatsu T, Mikami Y, Yamamoto T, Motoya S, Shinzaki S, Iwakiri R, Sugiura K, Nishimura K, Kajita M, Fernandez JL. Safety and Effectiveness of Vedolizumab in Patients with Moderate-to-Severe Ulcerative Colitis: An Interim Analysis of a Japanese Post-Marketing Surveillance Study. Adv Ther. 2023 Jun;40(6):2902-2914. doi: 10.1007/s12325-023-02500-6. Epub 2023 May 4. |
| Label | URL |
|---|---|
| To obtain more information on the study, click here/on this link | View source |
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Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Participants with ulcerative colitis who received Vedolizumab IV infusion 300 mg were enrolled. Participants received Vedolizumab IV infusion 300 mg as part of a routine normal practice.
Participants took part in the study at 197 investigative sites in Japan, from 1 February 2019 to 12 February 2025.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vedolizumab 300 mg | Vedolizumab IV infusion 300 mg, at Weeks 0, 2 and 6, and every 8 weeks thereafter, for up to 54 weeks. Participants received IV infusion as part of routine normal practice. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Analysis Set, The safety analysis set was defined as all participants who completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Vedolizumab 300 mg | Vedolizumab IV infusion 300 mg, at Weeks 0, 2 and 6, and every 8 weeks thereafter, for up to 54 weeks. Participants received IV infusion as part of routine normal practice. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Experienced at Least One Adverse Events (AEs) | An adverse event (AE) is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not the event is considered causally related to the use of the product. | Safety Analysis Set, The safety analysis set was defined as all participants who completed the study. | Posted | Count of Participants | Participants | Up to Week 54 |
|
Up to Week 54
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the study treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vedolizumab 300 mg | Vedolizumab IV infusion 300 mg, at Weeks 0, 2 and 6, and every 8 weeks thereafter, for up to 54 weeks. Participants received IV infusion as part of routine normal practice. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Takeda | +1-877-825-3327 | TrialDisclosures@takeda.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 29, 2024 | Aug 3, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 30, 2024 | Aug 3, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C543529 | vedolizumab |
| D007262 | Infusions, Intravenous |
| ID | Term |
|---|---|
| D061605 | Administration, Intravenous |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Change From Baseline in Complete Mayo Scores | Mayo score is used to assess UC disease activity. It consists of 4 sub-scores (stool frequency, rectal bleeding, findings on sigmoidoscopy, and physician's global assessment), each ranges from 0 to 3. Complete Mayo score sums 4 subscores and ranges from 0 to 12, with higher scores indicating more severe disease. | Baseline and Week 54 |
| Change From Baseline in Partial Mayo Scores | Mayo score is used to assess UC disease activity. It consists of 4 sub-scores (stool frequency, rectal bleeding, findings on sigmoidoscopy, and physician's global assessment), each ranges from 0 to 3. Partial Mayo score sums 3 subscores excluding the sigmoidoscopy sub-score and ranges from 0 to 9, with higher scores indicating more severe disease. | Baseline and Week 54 |
| Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score | The SIBDQ is an instrument used to assess quality of life (QOL) 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 is ranging from 10 to 70 with a higher score indicates a better health-related quality of life. Change from Baseline in SIBDQ total score was reported. | Baseline and Week 54 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
| Primary | Number of Participants Who Experienced at Least One Adverse Drug Reactions | An adverse event (AE) is defined as any untoward medical occurrence in a patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not the event is considered causally related to the use of the product. Adverse drug reaction refers to AE related to administered drug. | Safety Analysis Set, The safety analysis set was defined as all participants who completed the study. | Posted | Count of Participants | Participants | Up to Week 54 |
|
|
|
| Secondary | Number of Participants Who Had a Presence or Absence of Therapeutic Response After 3 Doses of Vedolizumab | Efficacy analysis set: The efficacy analysis set was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. | Posted | Count of Participants | Participants | Week 54 |
|
|
|
| Secondary | Number of Participants Who Continued the Therapy After 3 Doses of Vedolizumab | Efficacy analysis set: The efficacy analysis set was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. | Posted | Count of Participants | Participants | Week 54 |
|
|
|
| Secondary | Change From Baseline in Complete Mayo Scores | Mayo score is used to assess UC disease activity. It consists of 4 sub-scores (stool frequency, rectal bleeding, findings on sigmoidoscopy, and physician's global assessment), each ranges from 0 to 3. Complete Mayo score sums 4 subscores and ranges from 0 to 12, with higher scores indicating more severe disease. | Efficacy analysis set: The efficacy analysis set was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. The analyzed numbers were participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Week 54 |
|
|
|
| Secondary | Change From Baseline in Partial Mayo Scores | Mayo score is used to assess UC disease activity. It consists of 4 sub-scores (stool frequency, rectal bleeding, findings on sigmoidoscopy, and physician's global assessment), each ranges from 0 to 3. Partial Mayo score sums 3 subscores excluding the sigmoidoscopy sub-score and ranges from 0 to 9, with higher scores indicating more severe disease. | Efficacy analysis set: The efficacy analysis set was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. The analyzed numbers were participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Week 54 |
|
|
|
| Secondary | Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score | The SIBDQ is an instrument used to assess quality of life (QOL) 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 is ranging from 10 to 70 with a higher score indicates a better health-related quality of life. Change from Baseline in SIBDQ total score was reported. | Efficacy analysis set: The efficacy analysis set was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. The analyzed numbers were participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Week 54 |
|
|
|
| 5 |
| 1,091 |
| 82 |
| 1,091 |
| 29 |
| 1,091 |
| Atypical pneumonia | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
|
| Gastroenteritis Escherichia coli | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
|
| Liver abscess | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
|
| Cytomegalovirus enterocolitis | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
|
| Enteritis infectious | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
|
| Herpes zoster oticus | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA version 27.1 | Systematic Assessment |
|
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
|
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
|
| Metastases to lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
|
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
|
| Appendix cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
|
| Follicular lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 27.1 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 27.1 | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA version 27.1 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA version 27.1 | Systematic Assessment |
|
| Coronary artery stenosis | Cardiac disorders | MedDRA version 27.1 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA version 27.1 | Systematic Assessment |
|
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA version 27.1 | Systematic Assessment |
|
| Bronchiectasis | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.1 | Systematic Assessment |
|
| Eosinophilic pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.1 | Systematic Assessment |
|
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA version 27.1 | Systematic Assessment |
|
| Colitis ulcerative | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
|
| Intussusception | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
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| Melaena | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
|
| Oesophageal stenosis | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA version 27.1 | Systematic Assessment |
|
| Bile duct stone | Hepatobiliary disorders | MedDRA version 27.1 | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA version 27.1 | Systematic Assessment |
|
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA version 27.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 27.1 | Systematic Assessment |
|
| Polyarthritis | Musculoskeletal and connective tissue disorders | MedDRA version 27.1 | Systematic Assessment |
|
| Paroxysmal nocturnal haemoglobinuria | Renal and urinary disorders | MedDRA version 27.1 | Systematic Assessment |
|
| Diabetic nephropathy | Renal and urinary disorders | MedDRA version 27.1 | Systematic Assessment |
|
| Foetal death | Pregnancy, puerperium and perinatal conditions | MedDRA version 27.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA version 27.1 | Systematic Assessment |
|
| Neutrophil toxic granulation present | Investigations | MedDRA version 27.1 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA version 27.1 | Systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA version 27.1 | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA version 27.1 | Systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA version 27.1 | Systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA version 27.1 | Systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA version 27.1 | Systematic Assessment |
|
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| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D007263 |
| Infusions, Parenteral |