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)Ulcerative ColitisRegistryAdalimumabColitisGastroenteritisInflammatory Bowel DiseasesGastrointestinal DiseasesUlcerColitis, UlcerativeImmunomodulatory 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 accepting new patients
    La JollaCalifornia92037United States
  • Precision Research Institute - San Diego /ID# 103638 accepting new patients
    San DiegoCalifornia92114-3643United States
  • Precision Research Institute - San Diego /ID# 113445 accepting new patients
    San DiegoCalifornia92114-3643United 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