Vedolizumab IV 300 mg in the Treatment of Fistulizing Crohn's Disease
- Conditions
- Fistulizing Crohn’s Disease (CD)MedDRA version: 20.0Level: LLTClassification code 10075465Term: Fistulizing Crohn's diseaseSystem Organ Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2015-000852-12-GB
- Lead Sponsor
- Takeda Development Centre Europe, Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 34
-Adult subjects, aged 18 to 80 years, inclusive, with moderately to severely active CD and 1 to 3 draining perianal fistula(e) of at least 2 weeks duration.
-Subjects who have historically had an inadequate response with, lost
response to, or were intolerant to either conventional therapy or a TNFalpha antagonist for their underlying CD (does not require treatment failure for currently active draining fistula); for subjects from France only: subjects who have historically failed (ie, had an inadequate response with, lost response to, or was intolerant to) infliximab for treatment of their underlying CD or fistulizing CD.
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 85
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15
-Subjects who have perianal abscesses greater than 2 cm or an abscess that the investigator feels requires drainage based on either clinical assessment or MRI.
-Subjects who have a CDAI score greater than 400.
-Subjects who have ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
-Subjects who have significant anal or rectal stenosis.
-Subjects who have any evidence of an active infection (eg, sepsis, cytomegalovirus, or listeriosis) during Screening, other than related to the fistula(e).
-Subjects who have a positive progressive multifocal leukoencephalopathy (PML) subjective checklist.
-Subjects who have received any investigational or approved biologic or biosimilar agent within 60 days of randomization.
-Subjects who have had prior exposure to vedolizumab, natalizumab, efalizumab, or rituximab, etrolizumab, or anti- mucosal addressin cell adhesion molecule-1 (MAdCAM-1) therapy.
-Subjects who have active or latent tuberculosis.
-Subjects who have a known history of hepatitis B virus (HBV), hepatitis
C virus (HCV), acquired human immunodeficiency virus (HIV), or are
found to be seropositive at Screening.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method