A Long-Term Registry of Humira® (Adalimumab) in Patients With Moderately to Severely Active Ulcerative Colitis (UC)



Status:Recruiting
Conditions:Colitis, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 99
Updated:3/17/2019
Start Date:April 29, 2013
End Date:April 6, 2027
Contact:ABBVIE CALL CENTER
Email:abbvieclinicaltrials@abbvie.com
Phone:847.283.8955

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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)

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.


Inclusion Criteria:

- 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:

1. Is currently taking HUMIRA therapy and has received at least 8 weeks of therapy;
OR

2. 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

Exclusion Criteria:

- 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.
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