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

Active, not recruiting

• Conditions: Ulcerative Colitis (UC)

• Registration Number: NCT01848561
• Lead Sponsor: AbbVie

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-29
• Study First Submitted: 2013-05-03
• Study First Submitted QC: 2013-05-03
• Study First Posted: 2013-05-07
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-14
• Last Update Posted: 2025-07-16
• Primary Completion: 2028-06
• Study Completion: 2028-06-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 8250

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of long term safety of Adalimumab in patients with moderately to severely active UC	10 years observational period

Secondary Outcome Measures

Name	Time	Method
Evaluation of long term effectiveness of Adalimumab in patients with moderately to severely active UC who have had an inadequate response to conventional therapy	10 years observational period

Trial Locations

Locations (512)

Birmingham Gastroenterology Associates P.C /ID# 102063; 🇺🇸 Birmingham, Alabama, United States

University of Alabama at Birmingham - Main /ID# 131646; 🇺🇸 Birmingham, Alabama, United States

Longwood Research /ID# 118662; 🇺🇸 Huntsville, Alabama, United States

East View Medical Research, LLC /ID# 116259; 🇺🇸 Mobile, Alabama, United States

Mobile Medical & Diagnostic Center, AL /ID# 102064; 🇺🇸 Mobile, Alabama, United States

HOPE Research Institute /ID# 127947; 🇺🇸 Phoenix, Arizona, United States

Duplicate_University of Arizona Cancer Center - North Campus /ID# 140387; 🇺🇸 Tucson, Arizona, United States

University Of Arizona /ID# 117836; 🇺🇸 Tucson, Arizona, United States

Arkansas Gastroenterology /ID# 113898; 🇺🇸 North Little Rock, Arkansas, United States

Southern California Res. Ctr. /ID# 116898; 🇺🇸 Coronado, California, United States

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