Study to Evaluate the Safety and Efficacy of Two Drug Regimens in Subjects With Moderate to Severe Ulcerative Colitis

  • Interventional
  • Not Recruiting
  • NCT02065622
Eligibility Details Visit Clinicaltrials.gov

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.

Gender
All

Age Group
18 Years to 75 Years

Accepting Healthy Volunteers?
No

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).

At a Glance

National Government IDNCT02065622

IRB#IRB14-1096

Lead SponsorAbbVie

Lead PhysicianDavid T. Rubin

Collaborator(s)N/A

EligibilityAll
18 Years to 75 Years
Not Recruiting