Summary

Eligibility
for people ages 18-99 (full criteria)
Location
at La Jolla, California and other locations
Dates
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) Ulcerative Colitis Registry Adalimumab Colitis Gastroenteritis Inflammatory Bowel Diseases Gastrointestinal Diseases Colitis, Ulcerative Ulcer 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
    La Jolla California 92093 United States
  • Southern California Res. Ctr. /ID# 116898
    Coronado California 92118-1408 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
Links
Related Info
ID
NCT01848561
Study Type
Observational
Last Updated