NCT02065622
Brief summary
To evaluate safety and efficacy of two adalimumab dosing regimens for induction and maintenance (standard and higher dosing) in achieving clinical remission in subjects with moderately to severely active ulcerative colitis.
Interventional study
- 1
- 2
- 3
- 4
Age:
From 18 Years to 75 Years.
Inclusion Criteria:
- Diagnosis of Ulcerative Colitis (UC) for at least 90 days, confirmed by endoscopy
during Screening period.
- Active UC with Mayo Score of 6 to 12 points and endoscopy subscore of 2 to 3 despite
concurrent or prior treatment with a full and adequate course, in the opinion of the
Investigator, with oral corticosteroids or immunosuppressants or both. Mayo Score is
confirmed by central reader.
Exclusion Criteria:
- Subject with Crohn's disease (CD) or indeterminate colitis (IC).
- Current diagnosis of fulminant colitis and/or toxic megacolon.
- Subjects with disease limited to the rectum (ulcerative proctitis) during the
screening endoscopy.
- Chronic recurring infections or active tuberculosis (TB).
