NCT02065570
Brief summary
This study will evaluate higher versus standard active drug dosing regimens for induction and maintenance therapy in subjects with moderately to severely active Crohn's Disease and evidence of mucosal ulceration.
Interventional study
- 1
- 2
- 3
- 4
Age:
From 18 Years to 75 Years.
Inclusion Criteria:
- Diagnosis of Crohn's disease (CD) for at least 90 days, confirmed by endoscopy during
the Screening Period.
- Active CD with a Crohn's Disease Activity Index (CDAI) despite treatment with oral
corticosteroids and/or immunosuppressants.
- Mucosal ulceration on endoscopy.
Exclusion Criteria:
- Subject with ulcerative colitis or indeterminate colitis.
- Subject who has had surgical bowel resections in the past 6 months or is planning
resection.
- Subjects with an ostomy or ileoanal pouch.
- Subject with symptomatic bowel stricture or abdominal or peri-anal abcess.
- Subject who has short bowel syndrome.
- Chronic recurring infections or active Tuberculosis (TB).
