Summary

for people ages 18-99 (full criteria)
at La Jolla, California and other locations
study started
estimated completion:

Description

Summary

This is a registry study to evaluate the long-term safety and effectiveness of adalimumab in patients with moderately to severely active UC who are treated as recommended in the product label.

Official Title

A Long-Term Non-Interventional Postmarketing Study to Assess Safety and Effectiveness of HUMIRA® (Adalimumab) in Patients With Moderately to Severely Active Ulcerative Colitis (UC)

Keywords

Ulcerative Colitis (UC) Inflammatory Bowel Diseases Gastroenteritis Adalimumab Ulcerative Colitis Registry Gastrointestinal Diseases Colitis Ulcer Colitis, Ulcerative Immunomodulatory Therapy

Eligibility

You can join if…

Open to people ages 18-99

  • For enrollment into the HUMIRA treatment group; adult patients with moderately to severely active UC who has been prescribed HUMIRA therapy according to routine clinical practice and meets one of the following:
  • Is currently taking HUMIRA therapy and has received at least 8 weeks of therapy;OR
  • Is entering after participation in an Abbott or AbbVie sponsored UC study and;has received continuous HUMIRA therapy since initiation of therapy
  • For enrollment into the IMM treatment group; adult patients with moderately to severely active UC who has been prescribed IMM therapy, is currently taking IMM therapy, and has received at least 12 consecutive weeks of IMM therapy
  • Patients capable of and willing to grant authorization for use/disclosure of data being collected and provided to AbbVie prior to any registry-related data being collected, and to comply with the requirements of the Registry protocol

You CAN'T join if...

  • Patients on IMM therapy without a concurrent biologic if they cannot continue to be treated with IMM therapy or
  • Patients who are being treated with any investigational agents and/or approved biologics other than Humira.

Locations

  • Ucsd /Id# 133722 not yet accepting patients
    La Jolla California 92093 United States
  • Coastal Gastroenterology /ID# 108200 accepting new patients
    Encinitas California 92024 United States
  • Southern California Research Center /ID# 116898 accepting new patients
    Coronado California 92118 United States
  • Precision Research Institute, LLC /ID# 103638 accepting new patients
    San Diego California 92114 United States
  • Precision Research Institute, LLC /ID# 113445 accepting new patients
    San Diego California 92114 United States
  • Temecula Valley Endoscopy Center /ID# 118660 in progress, not accepting new patients
    Murrieta California 92563 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
Links
http://www.rxabbvie.com/
ID
NCT01848561
Study Type
Observational
Last Updated
May 9, 2018