Effectiveness and Safety of Vedolizumab SC as Maintenance Therapy in Crohn s Disease
- Conditions
- Crohn s DiseaseMedDRA version: 19.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2015-000481-58-ES
- Lead Sponsor
- Takeda Development Centre Europe, Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 824
1. The subject has a diagnosis of Crohn's disease (CD) established at least 3 months prior to screening, by clinical and endoscopic evidence
and corroborated by a histopathology report.
2. The subject has moderately to severely active CD.
3. The subject has CD involvement of the ileum and/or colon, at a minimum.
4. The subject has extensive colitis or pancolitis of >8 years duration or limited colitis of >12 years duration must have documented evidence that a surveillance colonoscopy was performed within 12 months of the initial screening visit.
5. Subjects with a family history of colorectal cancer, personal history of increased colorectal cancer risk, age >50 years, or other known risk factors must be up-to-date on colorectal cancer surveillance at screening.
6. The subject has demonstrated an inadequate response to, loss of response to, or intolerance of at least 1 of the following agents: immunomodulators, corticosteroids, or TNF-alpha antagonists.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 799
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25
1. The subject has evidence of abdominal abscess at the initial Screening Visit.
2. The subject has had extensive colonic resection, subtotal or total colectomy.
3. The subject has a history of >3 small bowel resections or diagnosis of short bowel syndrome.
4. The subject has received tube feeding, defined formula diets, or parenteral alimentation within 21 days prior to the administration of the first dose of study drug.
5. The subject has had ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
6. The subject has received any of the investigational or approved non-biologic therapies (eg, cyclosporine, tacrolimus, thalidomide, methotrexate, or tofacitinib except for those specifically listed in the protocol) for the treatment of underlying disease within 30 days or 5 half-lives of screening (which ever is longer).
7. The subject has received any investigational or approved biologic or biosimilar agent within 60 days or 5 half-lives of screening (which ever is longer).
8. The subject has used topical (rectal) treatment with 5-ASA or corticosteroid enemas/suppositories within 2 weeks of the administration of the first dose of study drug.
9. The subject requires currently or is anticipated to require surgical intervention for CD during the study.
10. The subject has a history or evidence of adenomatous colonic polyps that have not been removed.
11. The subject has a history or evidence of colonic mucosal dysplasia.
12. The subject has a suspected or confirmed diagnosis of ulcerative colitis, indeterminate colitis, ischaemic colitis, radiation colitis, diverticular disease associated with colitis, or microscopic colitis.
13. The subject has evidence of an active infection during the Screening Period.
14. The subject has evidence of, or treatment for, C. difficile infection or other intestinal pathogen with 28 days prior to first dose of study drug.
15. The subject has chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
16. The subject has active or latent TB, regardless of treatment history, as evidenced by any of the following:
17. The subject has any identified congenital or acquired immunodeficiency (eg, common variable immunodeficiency, human immunodeficiency virus [HIV] infection, organ transplantation).
18. The subject has received any live vaccinations within 30 days prior to screening.
19. The subject has clinically significant infection (eg, pneumonia, pyelonephritis) within 30 days prior to screening, or ongoing chronic infection.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the effect of vedolizumab SC maintenance treatment on clinical remission at Week 52 in subjects with moderately to severely active Crohn's disease who achieved clinical response at Week 6 following administration of vedolizumab IV at Weeks 0 and 2.;<br> Secondary Objective: To determine the effect of vedolizumab SC maintenance treatment on enhanced clinical response at Week 52 in subjects who achieved clinical response at Week 6 following administration of vedolizumab IV at Weeks 0 and 2.<br> ? To determine the effect of vedolizumab SC maintenance treatment on corticosteroid-free remission at Week 52 in subjects who achieved clinical response at Week 6 following administration of vedolizumab IV at Weeks 0 and 2.<br> ;Primary end point(s): Proportion of subjects with clinical remission, defined as Crohn s Disease Activity Index (CDAI) score ?150, at Week 52.;Timepoint(s) of evaluation of this end point: Week 52
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): Proportion of subjects with enhanced clinical response, defined as a 100 point decrease in CDAI score from Baseline (Week 0), at Week 52.<br> ? Proportion of subjects with corticosteroid-free remission, defined as subjects using oral corticosteroids at Baseline (Week 0) who have discontinued oral corticosteroids and are in clinical remission at Week 52.<br> ;Timepoint(s) of evaluation of this end point: Week 52