Status:
ACTIVE_NOT_RECRUITING
A Long-Term Registry of Humira® (Adalimumab) in Patients With Moderately to Severely Active Ulcerative Colitis (UC)
Lead Sponsor:
AbbVie
Conditions:
Ulcerative Colitis (UC)
Eligibility:
All Genders
18-99 years
Brief 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.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
April 29 2013
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
8250 Patients enrolled
Trial Details
Trial ID
NCT01848561
Start Date
April 29 2013
End Date
June 1 2028
Last Update
July 16 2025
Active Locations (512)
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1
Birmingham Gastroenterology Associates P.C /ID# 102063
Birmingham, Alabama, United States, 35209
2
University of Alabama at Birmingham - Main /ID# 131646
Birmingham, Alabama, United States, 35233
3
Longwood Research /ID# 118662
Huntsville, Alabama, United States, 35801
4
East View Medical Research, LLC /ID# 116259
Mobile, Alabama, United States, 36606