Crohn Disease, Ulcerative Colitis
Conditions
Keywords
Drug Therapy
Brief summary
Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. In this study, people with ulcerative colitis or Crohn's disease will be treated with vedolizumab. The main aim of the study is to check for side effects from vedolizumab. At the first visit, the study doctor will check who can take part. Participants will receive vedolizumab slowly through a vein (infusion). Participants will regularly visit the clinic for up to 46 weeks for more infusions of Vedolizumab. During these visits, the study doctor will check if there are any side effects from this treatment. Participants will visit the clinic for a final check-up up to 16 weeks after their final infusion of Vedolizumab. Clinic staff will arrange a phone call 6 months after their final infusion of Vedolizumab for a further check-up.
Detailed description
The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to treat people who have active UC or CD. The study will enroll approximately 150 patients. Participants will be assigned to the vedolizumab treatment group. •Vedolizumab 300 mg Vedolizumab 300 mg IV infusion will be administered once in Weeks 0, 2, 6 and 10 (CD-participants who have not shown a response can receive a dose at Week 10) during induction phase and in Weeks 14, 22, 30, 38 and 46 during maintenance phase. This multicentre trial will be conducted in India. The overall time to participate in this study is 74 weeks. Participants will make multiple visits to the clinic, and will be contacted by telephone plus a final visit after receiving their last dose of drug for a follow-up assessment.
Interventions
DRUGVedolizumab IV
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 65 Years
Healthy volunteers
No
Inclusion criteria
1. Has a diagnosis of moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD) at least 3 months prior to screening, with a Full Mayo Score of 6-12 for UC and a Harvey Bradshaw Index (HBI) score of \>=8 for CD at the time of enrolment. 2. Has demonstrated, an inadequate response to, loss of response to, or intolerance to at least 1 of the following agents: 1. Conventional therapy 2. TNF-α alpha antagonist
Exclusion criteria
1. Has undergone an ileostomy, colostomy, or has known fixed symptomatic stenosis of the intestine. 2. Has active or latent tuberculosis (TB). 3. Has had a prior exposure to vedolizumab or a history of hypersensitivity or allergies to vedolizumab, natalizumab, efalizumab, or rituximab. 4. Has a positive progressive multifocal leukoencephalopathy (PML) subjective symptom checklist during screening or prior to the administration of study drug on Day 1.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) | From first dose of study drug up to 24 weeks after the last dose (up to 70 weeks) | AE was defined as any untoward medical occurrence in clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with the treatment. AE can therefore be any unfavourable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with use of a drug, whether or not it is considered related to the drug. A SAE was any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of an existing hospitalization, resulted in significant disability or incapacity, was a congenital anomaly/birth defect or was a medically important event. An AESI (serious or nonserious) was one of scientific and medical concern specific to the compound or program. |
| Number of Participants With Adverse Drug Reactions (ADRs) and Unexpected ADRs | From first dose of study drug up to 24 weeks after the last dose (up to 70 weeks) | An ADR was an AE for which there was at least a reasonable suspicion of a causal relationship between an AE and a suspected medicinal product. An unexpected ADR was an ADR with the nature, severity, or outcome which was not consistent with the product insert. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of UC Participants With Clinical Remission at Weeks 14, 30 and 46 | At Weeks 14, 30 and 46 | Clinical remission for UC participants was defined as decrease in SCCAI of less than and equal to (\<=) 2 with no individual score \> 1. The SCCAI consists of five colitis activity symptom items (bowel frequency per day, bowel frequency per night, urgency of defecation, blood in stool, and general well-being) along with an assessment of extracolonic manifestations. Bowel frequency per night is scored on a 0-2 scale and General well-being is scored on a 0-4 scale. The other 3 symptom scores are scored on a 0-3 scale. 1 point each is added for the presence of any extracolonic manifestation (i.e., arthritis, erythema nodosum, pyoderma gangrenosum, and uveitis). The total overall possible scoring range was 0-19 with increasing scores being indicative of more colitis activity. |
| Percentage of CD Participants With Clinical Remission at Weeks 14, 30 and 46 | At Weeks 14, 30 and 46 | Clinical remission for CD participants was defined as HBI of \<= 4. HBI was composed of five clinical parameters: general well-being (0-4, where higher score means lower wellbeing), abdominal pain (0-3, higher score means more severe pain), number of liquid stools/day, abdominal mass (0-3, where higher score means presence of swelling in the abdomen), and complications (score 1 per item). Total score was the sum of individual parameters. The score ranged from a minimum score of 0 to no pre-specified maximum score as it depended on the number of liquid stools, where higher scores indicated more severe disease. The score \< 5 is considered as clinical remission, 5-7 mild, 8-16 moderate, and \>16 severe disease. A higher score indicated a worse outcome. |
| Percentage of UC and CD Participants Who Discontinued Vedolizumab | From first dose of study drug up to Week 46 | Vedolizumab discontinuation was defined as ceasing vedolizumab, or a treatment gap \>= 90 days between consecutive doses. |
| Percentage of UC Participants With Mucosal Healing at Week 46 | At Week 46 | Mucosal healing was based on endoscopic evidence of no inflammation and healing of the mucosa as defined by a Mayo endoscopic sub-score of \<=1 point. Full Mayo Score evaluated ulcerative colitis stage, based on four parameters: stool frequency, rectal bleeding, endoscopic evaluation, and Physician's global assessment. Each parameter of the score (including Mayo endoscopic sub-score) ranged from 0 (normal or inactive disease) to 3 (severe activity) yielding a total score of 0-12. The scores 0-2 were considered as clinical remission, 3-5 mild, 6-10 moderate, and 11-12 severe, with higher scores indicated more severe disease. |
| Percentage of UC Participants With Clinical Response at Weeks 14, 30 and 46 | At Weeks 14, 30 and 46 | Clinical response for UC participants was defined as decrease in Simple Clinical Colitis Activity Index (SCCAI) of greater than and equal to (\>=) 3 from baseline or by physician assessment of clinical response. The SCCAI consists of five colitis activity symptom items (bowel frequency per day, bowel frequency per night, urgency of defecation, blood in stool, and general well-being) along with an assessment of extracolonic manifestations. Bowel frequency per night is scored on a 0-2 scale and General well-being is scored on a 0-4 scale. The other 3 symptom scores are scored on a 0-3 scale. 1 point each is added for the presence of any extracolonic manifestation (i.e., arthritis, erythema nodosum, pyoderma gangrenosum, and uveitis). The total overall possible scoring range was 0-19 with increasing scores being indicative of more colitis activity. |
| Percentage of UC Participants With Endoscopic Response at Week 46 | At Week 46 | Endoscopic response was defined as decrease in Mayo endoscopic sub-score of \>=1 point in UC participants. Full Mayo Score evaluated ulcerative colitis stage, based on four parameters: stool frequency, rectal bleeding, endoscopic evaluation, and Physician's global assessment. Each parameter of the score (including Mayo endoscopic sub-score) ranges from 0 (normal or inactive disease) to 3 (severe activity) yielding a total score of 0-12. The scores 0-2 are considered as clinical remission, 3-5 mild, 6-10 moderate, and 11-12 severe, where higher scores indicated more severe disease. |
| Percentage of CD Participants With Endoscopic Response at Week 46 | At Week 46 | Endoscopic response was defined as \> 50% decrease in SES-CD in CD participants. SES-CD assessed the size of mucosal ulcers, ulcerated surface, endoscopic extension, and the presence and type of narrowings. Each of the four SES-CD variables was scored from 0 to 3, with the sum of scores for each variable ranged from 0 to 15 yielding a total SES-CD score of 0-60, where higher scores indicated more severe disease. |
| Change From Baseline in Patient-reported Quality of Life (Short Inflammatory Bowel Disease Questionnaire [SIBDQ]) Scores at Weeks 14, 30, and 46 | Baseline, Weeks 14, 30 and 46 | The SIBDQ was a valid and reliable instrument used to assess quality of life in adult participants with Inflammatory Bowel Disease (IBD). It was a 10-item questionnaire that included questions on 4 domains of health-related quality of life (HRQoL): bowel systems, emotional function, social function, and systemic function and was scored on a 7-point Likert scale from 1 (severe problem) to 7 (no problems at all). A total SIBDQ score was calculated by summing the scores from each domain; the total SIBDQ score ranged from 10 (poor HRQoL) to 70 (optimum HRQoL). Higher values of SIBDQ represented a better quality of life. |
| Percentage of CD Participants With Mucosal Healing at Week 46 | At Week 46 | Mucosal healing was based on endoscopic evidence of no inflammation and healing of the mucosa as defined by a Simple Endoscopic Score for Crohn Disease (SES-CD) 0-2 or SES-CD \<=4 and at least a 2-point reduction from baseline with no sub-score \>1. SES-CD assessed the size of mucosal ulcers, ulcerated surface, endoscopic extension, and the presence and type of narrowings. Each of the four SES-CD variables was scored from 0 to 3, with the sum of scores for each variable ranging from 0 to 15 yielding a total SES-CD score of 0-60, where higher scores indicated more severe disease. |
| Percentage of CD Participants With Clinical Response at Weeks 14, 30 and 46 | At Weeks 14, 30 and 46 | Clinical response for CD participants was defined as decrease in Harvey Bradshaw Index (HBI) of \>= 3 points from baseline. HBI was composed of five clinical parameters: general well-being (0-4, where higher score means lower wellbeing), abdominal pain (0-3, higher score means more severe pain), number of liquid stools/day, abdominal mass (0-3, where higher score means presence of swelling in the abdomen), and complications (score 1 per item). Total score was the sum of individual parameters. The score ranged from a minimum score of 0 to no pre-specified maximum score as it depended on the number of liquid stools, where higher scores indicated more severe disease. The score \< 5 is considered as clinical remission, 5-7 mild, 8-16 moderate, and \>16 severe disease. A higher score indicated a worse outcome. |
Countries
India
Participant flow
Recruitment details
Participants took part in the study at the 17 investigative sites in India from 08 December 2021 to 02 February 2024.
Pre-assignment details
A total of 150 participants diagnosed with moderate to severe Ulcerative Colitis (UC) (102 participants) and Crohn's Disease (CD) (48 participants) were enrolled to receive vedolizumab treatment in this study.
Participants by arm
| Arm | Count |
|---|---|
| UC Participants: Vedolizumab 300 mg Participants received vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, 6, 14, 22, 30, 38 and 46. | 102 |
| CD Participants: Vedolizumab 300 mg Participants received vedolizumab 300 mg, IV infusion, once at Weeks 0, 2, 6, 10 14, 22, 30, 38 and 46. | 48 |
| Total | 150 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 26 | 13 |
Baseline characteristics
| Characteristic | UC Participants: Vedolizumab 300 mg | CD Participants: Vedolizumab 300 mg | Total |
|---|---|---|---|
| Age, Continuous | 38.55 years STANDARD_DEVIATION 11.19 | 32.60 years STANDARD_DEVIATION 10.849 | 36.65 years STANDARD_DEVIATION 11.391 |
| Race/Ethnicity, Customized Race Indian | 102 Participants | 48 Participants | 150 Participants |
| Sex: Female, Male Female | 35 Participants | 32 Participants | 67 Participants |
| Sex: Female, Male Male | 67 Participants | 16 Participants | 83 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 102 | 0 / 48 |
| other Total, other adverse events | 25 / 102 | 19 / 48 |
| serious Total, serious adverse events | 6 / 102 | 2 / 48 |
Outcome results
Primary
Number of Participants With Adverse Drug Reactions (ADRs) and Unexpected ADRs
An ADR was an AE for which there was at least a reasonable suspicion of a causal relationship between an AE and a suspected medicinal product. An unexpected ADR was an ADR with the nature, severity, or outcome which was not consistent with the product insert.
Time frame: From first dose of study drug up to 24 weeks after the last dose (up to 70 weeks)
Population: SAS included all enrolled participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| UC Participants: Vedolizumab 300 mg | Number of Participants With Adverse Drug Reactions (ADRs) and Unexpected ADRs | Participants with ADRs | 5 Participants |
| UC Participants: Vedolizumab 300 mg | Number of Participants With Adverse Drug Reactions (ADRs) and Unexpected ADRs | Participants with Unexpected ADRs | 2 Participants |
| CD Participants: Vedolizumab 300 mg | Number of Participants With Adverse Drug Reactions (ADRs) and Unexpected ADRs | Participants with ADRs | 0 Participants |
| CD Participants: Vedolizumab 300 mg | Number of Participants With Adverse Drug Reactions (ADRs) and Unexpected ADRs | Participants with Unexpected ADRs | 0 Participants |
Primary
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
AE was defined as any untoward medical occurrence in clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with the treatment. AE can therefore be any unfavourable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with use of a drug, whether or not it is considered related to the drug. A SAE was any AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of an existing hospitalization, resulted in significant disability or incapacity, was a congenital anomaly/birth defect or was a medically important event. An AESI (serious or nonserious) was one of scientific and medical concern specific to the compound or program.
Time frame: From first dose of study drug up to 24 weeks after the last dose (up to 70 weeks)
Population: SAS included all enrolled participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| UC Participants: Vedolizumab 300 mg | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) | Participants with AESIs | 4 Participants |
| UC Participants: Vedolizumab 300 mg | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) | Participants with AEs | 54 Participants |
| UC Participants: Vedolizumab 300 mg | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) | Participants with SAEs | 6 Participants |
| CD Participants: Vedolizumab 300 mg | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) | Participants with AEs | 29 Participants |
| CD Participants: Vedolizumab 300 mg | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) | Participants with SAEs | 2 Participants |
| CD Participants: Vedolizumab 300 mg | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) | Participants with AESIs | 0 Participants |
Secondary
Change From Baseline in Patient-reported Quality of Life (Short Inflammatory Bowel Disease Questionnaire [SIBDQ]) Scores at Weeks 14, 30, and 46
The SIBDQ was a valid and reliable instrument used to assess quality of life in adult participants with Inflammatory Bowel Disease (IBD). It was a 10-item questionnaire that included questions on 4 domains of health-related quality of life (HRQoL): bowel systems, emotional function, social function, and systemic function and was scored on a 7-point Likert scale from 1 (severe problem) to 7 (no problems at all). A total SIBDQ score was calculated by summing the scores from each domain; the total SIBDQ score ranged from 10 (poor HRQoL) to 70 (optimum HRQoL). Higher values of SIBDQ represented a better quality of life.
Time frame: Baseline, Weeks 14, 30 and 46
Population: SAS included all enrolled participants who received at least 1 dose of study drug. Here, overall number of participants analyzed signified participants who were evaluable for this outcome measure and number analyzed signified participants who were evaluable at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UC Participants: Vedolizumab 300 mg | Change From Baseline in Patient-reported Quality of Life (Short Inflammatory Bowel Disease Questionnaire [SIBDQ]) Scores at Weeks 14, 30, and 46 | Change at Week 14 | 8.4 score on a scale | Standard Deviation 12.91 |
| UC Participants: Vedolizumab 300 mg | Change From Baseline in Patient-reported Quality of Life (Short Inflammatory Bowel Disease Questionnaire [SIBDQ]) Scores at Weeks 14, 30, and 46 | Change at Week 46 | 13.0 score on a scale | Standard Deviation 12.84 |
| UC Participants: Vedolizumab 300 mg | Change From Baseline in Patient-reported Quality of Life (Short Inflammatory Bowel Disease Questionnaire [SIBDQ]) Scores at Weeks 14, 30, and 46 | Change at Week 30 | 12.9 score on a scale | Standard Deviation 13.16 |
| CD Participants: Vedolizumab 300 mg | Change From Baseline in Patient-reported Quality of Life (Short Inflammatory Bowel Disease Questionnaire [SIBDQ]) Scores at Weeks 14, 30, and 46 | Change at Week 14 | 8.3 score on a scale | Standard Deviation 12.24 |
| CD Participants: Vedolizumab 300 mg | Change From Baseline in Patient-reported Quality of Life (Short Inflammatory Bowel Disease Questionnaire [SIBDQ]) Scores at Weeks 14, 30, and 46 | Change at Week 30 | 8.4 score on a scale | Standard Deviation 14.31 |
| CD Participants: Vedolizumab 300 mg | Change From Baseline in Patient-reported Quality of Life (Short Inflammatory Bowel Disease Questionnaire [SIBDQ]) Scores at Weeks 14, 30, and 46 | Change at Week 46 | 10.6 score on a scale | Standard Deviation 15.91 |
Secondary
Percentage of CD Participants With Clinical Remission at Weeks 14, 30 and 46
Clinical remission for CD participants was defined as HBI of \<= 4. HBI was composed of five clinical parameters: general well-being (0-4, where higher score means lower wellbeing), abdominal pain (0-3, higher score means more severe pain), number of liquid stools/day, abdominal mass (0-3, where higher score means presence of swelling in the abdomen), and complications (score 1 per item). Total score was the sum of individual parameters. The score ranged from a minimum score of 0 to no pre-specified maximum score as it depended on the number of liquid stools, where higher scores indicated more severe disease. The score \< 5 is considered as clinical remission, 5-7 mild, 8-16 moderate, and \>16 severe disease. A higher score indicated a worse outcome.
Time frame: At Weeks 14, 30 and 46
Population: SAS included all enrolled participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| UC Participants: Vedolizumab 300 mg | Percentage of CD Participants With Clinical Remission at Weeks 14, 30 and 46 | At Week 14 | 47.9 percentage of participants |
| UC Participants: Vedolizumab 300 mg | Percentage of CD Participants With Clinical Remission at Weeks 14, 30 and 46 | At Week 30 | 45.8 percentage of participants |
| UC Participants: Vedolizumab 300 mg | Percentage of CD Participants With Clinical Remission at Weeks 14, 30 and 46 | At Week 46 | 56.3 percentage of participants |
Secondary
Percentage of CD Participants With Clinical Response at Weeks 14, 30 and 46
Clinical response for CD participants was defined as decrease in Harvey Bradshaw Index (HBI) of \>= 3 points from baseline. HBI was composed of five clinical parameters: general well-being (0-4, where higher score means lower wellbeing), abdominal pain (0-3, higher score means more severe pain), number of liquid stools/day, abdominal mass (0-3, where higher score means presence of swelling in the abdomen), and complications (score 1 per item). Total score was the sum of individual parameters. The score ranged from a minimum score of 0 to no pre-specified maximum score as it depended on the number of liquid stools, where higher scores indicated more severe disease. The score \< 5 is considered as clinical remission, 5-7 mild, 8-16 moderate, and \>16 severe disease. A higher score indicated a worse outcome.
Time frame: At Weeks 14, 30 and 46
Population: SAS included all enrolled participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| UC Participants: Vedolizumab 300 mg | Percentage of CD Participants With Clinical Response at Weeks 14, 30 and 46 | At Week 14 | 72.9 percentage of participants |
| UC Participants: Vedolizumab 300 mg | Percentage of CD Participants With Clinical Response at Weeks 14, 30 and 46 | At Week 30 | 70.8 percentage of participants |
| UC Participants: Vedolizumab 300 mg | Percentage of CD Participants With Clinical Response at Weeks 14, 30 and 46 | At Week 46 | 68.8 percentage of participants |
Secondary
Percentage of CD Participants With Endoscopic Response at Week 46
Endoscopic response was defined as \> 50% decrease in SES-CD in CD participants. SES-CD assessed the size of mucosal ulcers, ulcerated surface, endoscopic extension, and the presence and type of narrowings. Each of the four SES-CD variables was scored from 0 to 3, with the sum of scores for each variable ranged from 0 to 15 yielding a total SES-CD score of 0-60, where higher scores indicated more severe disease.
Time frame: At Week 46
Population: SAS included all enrolled participants who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| UC Participants: Vedolizumab 300 mg | Percentage of CD Participants With Endoscopic Response at Week 46 | 12.5 percentage of participants |
Secondary
Percentage of CD Participants With Mucosal Healing at Week 46
Mucosal healing was based on endoscopic evidence of no inflammation and healing of the mucosa as defined by a Simple Endoscopic Score for Crohn Disease (SES-CD) 0-2 or SES-CD \<=4 and at least a 2-point reduction from baseline with no sub-score \>1. SES-CD assessed the size of mucosal ulcers, ulcerated surface, endoscopic extension, and the presence and type of narrowings. Each of the four SES-CD variables was scored from 0 to 3, with the sum of scores for each variable ranging from 0 to 15 yielding a total SES-CD score of 0-60, where higher scores indicated more severe disease.
Time frame: At Week 46
Population: SAS included all enrolled participants who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| UC Participants: Vedolizumab 300 mg | Percentage of CD Participants With Mucosal Healing at Week 46 | 8.3 percentage of participants |
Secondary
Percentage of UC and CD Participants Who Discontinued Vedolizumab
Vedolizumab discontinuation was defined as ceasing vedolizumab, or a treatment gap \>= 90 days between consecutive doses.
Time frame: From first dose of study drug up to Week 46
Population: SAS included all enrolled participants who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| UC Participants: Vedolizumab 300 mg | Percentage of UC and CD Participants Who Discontinued Vedolizumab | 25.5 percentage of participants |
| CD Participants: Vedolizumab 300 mg | Percentage of UC and CD Participants Who Discontinued Vedolizumab | 27.1 percentage of participants |
Secondary
Percentage of UC Participants With Clinical Remission at Weeks 14, 30 and 46
Clinical remission for UC participants was defined as decrease in SCCAI of less than and equal to (\<=) 2 with no individual score \> 1. The SCCAI consists of five colitis activity symptom items (bowel frequency per day, bowel frequency per night, urgency of defecation, blood in stool, and general well-being) along with an assessment of extracolonic manifestations. Bowel frequency per night is scored on a 0-2 scale and General well-being is scored on a 0-4 scale. The other 3 symptom scores are scored on a 0-3 scale. 1 point each is added for the presence of any extracolonic manifestation (i.e., arthritis, erythema nodosum, pyoderma gangrenosum, and uveitis). The total overall possible scoring range was 0-19 with increasing scores being indicative of more colitis activity.
Time frame: At Weeks 14, 30 and 46
Population: SAS included all enrolled participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| UC Participants: Vedolizumab 300 mg | Percentage of UC Participants With Clinical Remission at Weeks 14, 30 and 46 | At Week 30 | 43.1 percentage of participants |
| UC Participants: Vedolizumab 300 mg | Percentage of UC Participants With Clinical Remission at Weeks 14, 30 and 46 | At Week 14 | 39.2 percentage of participants |
| UC Participants: Vedolizumab 300 mg | Percentage of UC Participants With Clinical Remission at Weeks 14, 30 and 46 | At Week 46 | 52.0 percentage of participants |
Secondary
Percentage of UC Participants With Clinical Response at Weeks 14, 30 and 46
Clinical response for UC participants was defined as decrease in Simple Clinical Colitis Activity Index (SCCAI) of greater than and equal to (\>=) 3 from baseline or by physician assessment of clinical response. The SCCAI consists of five colitis activity symptom items (bowel frequency per day, bowel frequency per night, urgency of defecation, blood in stool, and general well-being) along with an assessment of extracolonic manifestations. Bowel frequency per night is scored on a 0-2 scale and General well-being is scored on a 0-4 scale. The other 3 symptom scores are scored on a 0-3 scale. 1 point each is added for the presence of any extracolonic manifestation (i.e., arthritis, erythema nodosum, pyoderma gangrenosum, and uveitis). The total overall possible scoring range was 0-19 with increasing scores being indicative of more colitis activity.
Time frame: At Weeks 14, 30 and 46
Population: SAS included all enrolled participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| UC Participants: Vedolizumab 300 mg | Percentage of UC Participants With Clinical Response at Weeks 14, 30 and 46 | At Week 30 | 62.7 percentage of participants |
| UC Participants: Vedolizumab 300 mg | Percentage of UC Participants With Clinical Response at Weeks 14, 30 and 46 | At Week 46 | 73.5 percentage of participants |
| UC Participants: Vedolizumab 300 mg | Percentage of UC Participants With Clinical Response at Weeks 14, 30 and 46 | At Week 14 | 54.9 percentage of participants |
Secondary
Percentage of UC Participants With Endoscopic Response at Week 46
Endoscopic response was defined as decrease in Mayo endoscopic sub-score of \>=1 point in UC participants. Full Mayo Score evaluated ulcerative colitis stage, based on four parameters: stool frequency, rectal bleeding, endoscopic evaluation, and Physician's global assessment. Each parameter of the score (including Mayo endoscopic sub-score) ranges from 0 (normal or inactive disease) to 3 (severe activity) yielding a total score of 0-12. The scores 0-2 are considered as clinical remission, 3-5 mild, 6-10 moderate, and 11-12 severe, where higher scores indicated more severe disease.
Time frame: At Week 46
Population: SAS included all enrolled participants who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| UC Participants: Vedolizumab 300 mg | Percentage of UC Participants With Endoscopic Response at Week 46 | 21.6 percentage of participants |
Secondary
Percentage of UC Participants With Mucosal Healing at Week 46
Mucosal healing was based on endoscopic evidence of no inflammation and healing of the mucosa as defined by a Mayo endoscopic sub-score of \<=1 point. Full Mayo Score evaluated ulcerative colitis stage, based on four parameters: stool frequency, rectal bleeding, endoscopic evaluation, and Physician's global assessment. Each parameter of the score (including Mayo endoscopic sub-score) ranged from 0 (normal or inactive disease) to 3 (severe activity) yielding a total score of 0-12. The scores 0-2 were considered as clinical remission, 3-5 mild, 6-10 moderate, and 11-12 severe, with higher scores indicated more severe disease.
Time frame: At Week 46
Population: SAS included all enrolled participants who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| UC Participants: Vedolizumab 300 mg | Percentage of UC Participants With Mucosal Healing at Week 46 | 22.5 percentage of participants |