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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Vedolizumab IV infusion
Government General Hospital
Guntur, Andhra Pradesh, India
Institute of Gastroenterology and Liver Disease Dispur Hospitals
Guwahati, Assam, India
Indira Gandhi Institute of Medical Sciences
Patna, Bihar, India
Gastroplus Digestive Disease Centre Pvt.Ltd
Ahmedabad, Gujarat, India
Surat Institute of Digestive Sciences
Surat, Gujarat, India
Banglore Medical College & Research Institute
Bangalore, Karnatka, India
Midas Multispeciality Hospital
Nagpur, Maharashtra, India
Dr. Ram Manohar Lohia Hospita Hospital
New Delhi, National Capital Territory of Delhi, India
Maulana Azad Medical college & Associated G B Pant Hospital
New Delhi, National Capital Territory of Delhi, India
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, India
...and 7 more locations
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)
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)
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
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
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
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
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
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
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
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
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
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
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