Study to Evaluate the Safety and Efficacy of Two Drug Regimens in Subjects With Moderate to Severe Ulcerative Colitis
Status: | Active, not recruiting |
---|---|
Conditions: | Colitis, Colitis, Gastrointestinal |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 2/17/2019 |
Start Date: | March 27, 2014 |
End Date: | November 15, 2019 |
A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis
To evaluate safety and efficacy of two dosing regimens in achieving clinical remission in
subjects with moderately to severely active Ulcerative Colitis.
subjects with moderately to severely active Ulcerative Colitis.
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.
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).
We found this trial at
44
sites
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480 Honeysuckle Road
Dothan, Alabama 36305
Dothan, Alabama 36305
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1211 Medical Center Drive
Nashville, Tennessee 37212
Nashville, Tennessee 37212
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