Colitis, Ulcerative, Crohn Disease
Conditions
Keywords
Drug Therapy
Brief summary
The purpose of this study is to monitor ongoing safety in participants with ulcerative colitis (UC) and Crohn's disease (CD) and to provide access to vedolizumab for qualifying participants who, in the opinion of the investigator, continue to derive benefit from vedolizumab and for whom continued treatment with vedolizumab is desired because there is no other comparable product available or the participant may be expected to develop worsening of disease if they were to modify treatment.
Detailed description
The drug being used in this study is called vedolizumab, which is being used to treat people who have ulcerative colitis or Crohn's disease. This study will monitor ongoing safety in the people who take vedolizumab. Participants who have successfully completed the participation in qualifying vedolizumab clinical studies will be enrolled and assigned to receive: • Vedolizumab 300 mg All participants will receive an intravenous (IV) infusion once every 8 weeks until vedolizumab is available through commercial channels, including reimbursement, for the participant's clinical scenario, or until participant withdrawal, whichever comes first. (Per MM approval, dosing regimen may be modified) This multicenter trial will be conducted worldwide. Participants will make multiple visits to the clinic and a final visit at 18 weeks after receiving the last dose of study infusion of vedolizumab for a safety follow-up assessment.
Interventions
DRUGVedolizumab
Vedolizumab IV infusion
Sponsors
Takeda
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Received vedolizumab (excluding comparator or placebo participants) during participation in a qualifying vedolizumab study. 2. In the opinion of the investigator, the participant is continuing to derive benefit from vedolizumab and continued treatment with vedolizumab is desired because there is no other comparable product available or the participant may be expected to develop worsening of disease if they were to modify treatment. 3. A male participant who is non-sterilized and sexually active with a female partner of childbearing potential agrees to use adequate contraception from signing of informed consent throughout the duration of the study and for 18 weeks after last dose. 4. A female participant of childbearing potential who is sexually active with a non-sterilized male partner agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study and for 18 weeks after last dose.
Exclusion criteria
1. For the participant's particular clinical scenario, vedolizumab is currently available to the participant through commercial channels, including reimbursement. 2. Has any clinical condition or prior therapy that, in the opinion of the investigator, would make the participant unsuitable for the study or unable to comply with the dosing requirements or poses a risk to the participant being in the study. 3. If female, the participant is pregnant or lactating or intending to become pregnant before, during, or within 18 weeks after participating in this study; or intending to donate ova during such time period. 4. If male, the participant intends to donate sperm during the course of this study or for 18 weeks thereafter. 5. Has received a live vaccine in the last 18 weeks or is in need of a live vaccine during the study or up to 18 weeks after the last study dose.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years) | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the study drug. A SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires participant hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect or is an important medical event. Percentages are rounded off to the nearest decimal point. |
| Percentage of Participants With Adverse Events of Special Interest (AESIs) | From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years) | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the study drug. AESIs included serious infections (opportunistic infections, such as progressive multifocal leukoencephalopathy \[PML\]), malignancies, liver injury, infusion-related hypersensitivity reactions, and injection site reactions. Percentages are rounded off to the nearest decimal point. |
Countries
Australia, Bulgaria, Czechia, Estonia, Hungary, India, Italy, Latvia, Malaysia, New Zealand, Poland, Romania, Russia, Serbia, South Africa, South Korea, Turkey (Türkiye), Ukraine
Participant flow
Recruitment details
Participants took part in the study at 78 investigative sites in Australia, Bulgaria, the Czech Republic, Estonia, Hungary, India, Italy, Republic of Korea, Latvia, Malaysia, New Zealand, Poland, Romania, Russian Federation, Serbia, South Africa, Turkey, and Ukraine from 01 August 2016 to 03 January 2023.
Pre-assignment details
A total of 331 participants with a diagnosis of ulcerative colitis (UC) or Crohn's disease (CD) who have successfully completed the participation in qualifying vedolizumab clinical studies (C13008 \[NCT00790933\] and MLN0002-3028 \[NCT02425111\]) were enrolled in this extended access program (XAP) study to receive vedolizumab 300 mg.
Participants by arm
| Arm | Count |
|---|---|
| Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once Q8W that maybe reduced to once Q4W based on the investigator's judgment of participant's clinical status and acknowledged by the medical monitor for up to 6 years. | 331 |
| Total | 331 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 9 |
| Overall Study | Lost to Follow-up | 8 |
| Overall Study | No Longer Clinically Benefiting | 27 |
| Overall Study | Pregnancy | 6 |
| Overall Study | Reason Not Specified | 12 |
| Overall Study | Study Termination | 65 |
| Overall Study | Voluntary Withdrawal | 54 |
Baseline characteristics
| Characteristic | Vedolizumab 300 mg | — |
|---|---|---|
| Age, Continuous | 44.5 years STANDARD_DEVIATION 12.29 | — |
| Body Mass Index (BMI) | 26.16 kilograms per meter square (kg/m^2) STANDARD_DEVIATION 5.667 | — |
| Height | 171.4 centimeters (cm) STANDARD_DEVIATION 11.06 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | — |
| Race (NIH/OMB) Asian | 36 Participants | — |
| Race (NIH/OMB) Black or African American | 3 Participants | — |
| Race (NIH/OMB) More than one race | 0 Participants | — |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | — |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | — |
| Race (NIH/OMB) White | 292 Participants | — |
| Region of Enrollment Australia | 13 Participants | — |
| Region of Enrollment Bulgaria | 4 Participants | — |
| Region of Enrollment Czech Republic | 115 Participants | — |
| Region of Enrollment Estonia | 4 Participants | — |
| Region of Enrollment Hungary | 46 Participants | — |
| Region of Enrollment India | 13 Participants | — |
| Region of Enrollment Italy | 5 Participants | — |
| Region of Enrollment Korea, Republic of | 21 Participants | — |
| Region of Enrollment Latvia | 1 Participants | — |
| Region of Enrollment Malaysia | 1 Participants | — |
| Region of Enrollment New Zealand | 6 Participants | — |
| Region of Enrollment Poland | 41 Participants | — |
| Region of Enrollment Romania | 3 Participants | — |
| Region of Enrollment Russian Federation | 35 Participants | — |
| Region of Enrollment Serbia | 1 Participants | — |
| Region of Enrollment South Africa | 12 Participants | — |
| Region of Enrollment Turkey | 5 Participants | — |
| Region of Enrollment Ukraine | 5 Participants | — |
| Sex: Female, Male Female | 147 Participants | — |
| Sex: Female, Male Male | 184 Participants | — |
| Weight | 76.91 kilograms (kg) STANDARD_DEVIATION 16.988 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 331 |
| other Total, other adverse events | 100 / 331 |
| serious Total, serious adverse events | 50 / 331 |
Outcome results
Primary
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the study drug. A SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires participant hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect or is an important medical event. Percentages are rounded off to the nearest decimal point.
Time frame: From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
Population: FAS consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vedolizumab 300 mg | Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 61.9 percentage of participants |
| Vedolizumab 300 mg | Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 15.1 percentage of participants |
Primary
Percentage of Participants With Adverse Events of Special Interest (AESIs)
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the study drug. AESIs included serious infections (opportunistic infections, such as progressive multifocal leukoencephalopathy \[PML\]), malignancies, liver injury, infusion-related hypersensitivity reactions, and injection site reactions. Percentages are rounded off to the nearest decimal point.
Time frame: From first dose of study drug in this XAP study through 18 weeks after the last dose of study drug (up to 6.3 years)
Population: FAS consisted of all participants enrolled in the XAP study, who received at least 1 dose of study drug (i.e., vedolizumab IV treatment), including the dose given at T0 (last vedolizumab dose in the qualifying study).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vedolizumab 300 mg | Percentage of Participants With Adverse Events of Special Interest (AESIs) | 3.9 percentage of participants |