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 accepting new patients
    La Jolla California 92037 United States
  • University of Utah accepting new patients
    Salt Lake City Utah 84112-5500 United States
  • Advanced Research Institute accepting new patients
    Ogden Utah 84405-6779 United States
  • Rocky Mountain Clinical Resear accepting new patients
    Wheat Ridge Colorado 80033 United States
  • The Oregon Clinic- Gastro West completed
    Portland Oregon 97225 United States
  • University of Washington not yet accepting patients
    Seattle Washington 98109 United States
  • Austin Center for Clinical Res accepting new patients
    Austin Texas 78756 United States
  • Texas Digestive Disease Consul accepting new patients
    Southlake Texas 76092 United States
  • Percuro Clinical Research, Ltd not yet accepting patients
    Victoria British Columbia V8V 3M9 Canada
  • DHAT Research Institute accepting new patients
    Richardson Texas 75082 United States
  • Gastro United of Tulsa accepting new patients
    Tulsa Oklahoma 74135 United States
  • Biopharma Informatic Research accepting new patients
    Houston Texas 77084 United States
  • University of Calgary accepting new patients
    Calgary Alberta T2N 4Z6 Canada
  • Zeidler Ledcor Centre accepting new patients
    Edmonton Alberta T6G 2X8 Canada
  • Covenant Health not yet accepting patients
    Edmonton Alberta T6L 6K3 Canada
  • Louisiana Research Ctr. LLC accepting new patients
    Shreveport Louisiana 71105-6800 United States
  • Ctr for Digest and Liver Dis accepting new patients
    Mexico Missouri 65265 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
Links
http://rxabbvie.com/
ID
NCT02065622
Phase
Phase 3
Study Type
Interventional
Last Updated
May 8, 2018