Summary

for people ages 18-75 (full criteria)
at La Jolla, California and other locations
study started
estimated completion:

Description

Summary

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

Official Title

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

Keywords

Ulcerative Colitis (UC) Ulcerative Colitis Colitis Ulcer Colitis, Ulcerative Adalimumab Higher Induction Dose Higher Maintenance Dose

Eligibility

You can join if…

Open to people ages 18-75

  • 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.

You CAN'T join if...

  • 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).

Locations

  • Ucsd /Id# 122313
    La Jolla California 92037 United States
  • University of Utah /ID# 122333
    Salt Lake City Utah 84112-5500 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
Links
http://rxabbvie.com/
ID
NCT02065622
Phase
Phase 3
Study Type
Interventional
Last Updated