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

  • STATUS
    Recruiting
  • sponsor
    AbbVie
Updated on 25 March 2021

Summary

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

Description

To evaluate safety and efficacy of two dosing regimens in achieving clinical remission in subjects with moderately to severely active Ulcerative Colitis.

Details
Condition Ulcerative Colitis
Clinical Study IdentifierTX153784
SponsorAbbVie
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

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)
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