A Study of Vedolizumab in People With Ulcerative Colitis and Crohns Disease
- Conditions
- Health Condition 1: K508- Crohns disease of both small andlarge intestineHealth Condition 2: K519- Ulcerative colitis, unspecified
- Registration Number
- CTRI/2021/11/037814
- Lead Sponsor
- Ms Takeda Pharmaceutical India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1. In the opinion of the investigator, the patient (or, when applicable, the patientâ??s legally acceptable representative) is capable of understanding and complying with the protocol requirements and able to provide a signed and dated written informed consent form (ICF) and any required privacy authorization prior to the initiation of any study procedures.
2. The patient is aged between 18 to 65 years both inclusive at the screening visit
3. The patient has a diagnosis of moderately to severely active UC or 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 enrollment
4. The patient has UC or CD with involvement of the ileum and/or colon that has been assessed by colonoscopy/ileo-colonoscopy as applicable within 30 days before or at the time of screening.
5. Patients with extensive colitis or pancolitis of >8 years duration or left-sided colitis >12 years duration must have documented evidence that a surveillance colonoscopy was performed within 12 months of the initial Screening Visit (if not performed in previous 12 months, must be performed during Screening).
6. The patient has demonstrated, an inadequate response to, loss of response to, or intolerance to at least 1 of the following agents:
a.Conventional therapy
b.TNF-α alpha antagonist
7. Male patient who is nonsterilized 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
8. A female patient of childbearing potential who is sexually active with a nonsterilized 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. Female patient not of childbearing potential are defined as those who have been surgically sterilized (hysterectomy, bilateral oophorectomy, or tubal ligation) or who are postmenopausal (eg, defined as at least 1 year since last regular menses with an appropriate clinical profile [ie, age appropriate, history of vasomotor symptoms] , confirmed before any study drug is implemented).
1.The patient has an evidence of abdominal abscess at the screening visit.
2.The patient has a history of extensive colon resections, subtotal or total colectomy.
3.The patient has undergone an ileostomy, colostomy, or has known fixed symptomatic stenosis of the intestine.
4.The patient has active or latent tuberculosis (TB).
5.The patient has hepatitis B virus (HBV) or hepatitis C virus (HCV) infection; has any identified congenital or acquired immunodeficiency (eg, common variable immunodeficiency, human immunodeficiency virus [HIV] infection, organ transplantation).
6.The patient has evidence of active Clostridium difficile infection or is having treatment for C. difficile infection or other intestinal pathogens during Screening or has evidence of an active infection during Screening.
7.The patient currently requires or has a planned surgical intervention for the indication to be studied during the study. Patients who had a surgical procedure requiring general anesthesia within 30 days prior to screening or are planning to undergo major surgery during the study period will also be excluded from the study.
8.The patient has received any investigational compound within 60 days of enrollment.
9.The patient has received any live vaccinations within 30 days prior to enrollment.
10.The patient has received any biologics within 60 days (or 5-half-lives of the drug) of enrollment.
11.The patient has had a prior exposure to vedolizumab or a history of hypersensitivity or allergies to vedolizumab, natalizumab, efalizumab, or rituximab.
12.The patient has any unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal, GI, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, an active psychiatric problem, or other medical disorder that, in the opinion of the investigator, would confound the study results or compromise patient safety.
13.The patient has a history of malignancy.
14.The patient has any of the following laboratory abnormalities during the Screening Period:
a.Hemoglobin level <8 g/dL
b.White blood cell (WBC) count <3 x 109/L
c.Platelet count <100 x 109/L or >1200 x 109/L
d.Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 x the upper limit of normal (ULN)
e.Serum creatinine >2 x ULN
15.The patient has a history of any major neurological disorder, including stroke, multiple sclerosis, brain tumor, or neurodegenerative disease,
16.The patient has a positive PML subjective symptom checklist during screening or prior to the administration of study drug on Day 1.
17.The patient has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to enrollment.
18.If female, the patient is pregnant or lactating or intending to become pregnant before, during, or within 16 weeks after completion of participation in the study; or intending to donate ova during such time period.
19.If male, the patient intends to donate sperm during the course of this study or for 16 weeks thereafter.
20.The patient is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
21.The patient has c
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the safety of vedolizumab IV in patients with UC or CD in India. Incidence of AEs, SAEs, AEs of special interest (AESIs), ADRs, and unexpected ADRsTimepoint: Throughout the study
- Secondary Outcome Measures
Name Time Method To assess the efficacy of vedolizumab IV in patients with UC or CDTimepoint: Weeks 14, 30, and 46