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

NCT01848561 · tracked via the Priya Life Science Italy tracker

Sponsor

AbbVie

Phase

Observational

Started

2013-04-29

Last updated

2025-07-16

Condition(s) studied

Ulcerative Colitis (UC)

Study 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

Sex

ALL

Min age

18 Years

Max age

99 Years

Healthy volunteers

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.

Primary outcome measure(s)

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

Trial sites (512)

Facility	City	Region
Birmingham Gastroenterology Associates P.C /ID# 102063	Birmingham	Alabama
University of Alabama at Birmingham - Main /ID# 131646	Birmingham	Alabama
Longwood Research /ID# 118662	Huntsville	Alabama
East View Medical Research, LLC /ID# 116259	Mobile	Alabama
Mobile Medical & Diagnostic Center, AL /ID# 102064	Mobile	Alabama
HOPE Research Institute /ID# 127947	Phoenix	Arizona
Duplicate_University of Arizona Cancer Center - North Campus /ID# 140387	Tucson	Arizona
University Of Arizona /ID# 117836	Tucson	Arizona
Arkansas Gastroenterology /ID# 113898	North Little Rock	Arkansas
Southern California Res. Ctr. /ID# 116898	Coronado	California
Moores Cancer Center at UC San Diego /ID# 133722	La Jolla	California
McGuire, Jr. La Mirada, CA /ID# 116257	La Mirada	California
Atay, Los Alamitos, CA /ID# 110175	Los Alamitos	California
Temecula Valley Endoscopy Ctr /ID# 118660	Murrieta	California
Community Clinical Trials, CA /ID# 117335	Orange	California
Digestive Care Medical Center /ID# 122075	San Carlos	California
Precision Research Institute - San Diego /ID# 103638	San Diego	California
Precision Research Institute - San Diego /ID# 113445	San Diego	California
Santa Monica Research Institut /ID# 118675	Santa Monica	California
Duplicate_St. Joseph Heritage Group - Yorba Linda /ID# 133721	Yorba Linda	California
Duplicate_Western States Clinical Research, Inc. /ID# 116237	Wheat Ridge	Colorado
Gastro Assoc of Fair County /ID# 113443	Bridgeport	Connecticut
Gastroenterology Center of Connecticut /ID# 102057	Hamden	Connecticut
Middlesex Hospital /ID# 122077	Middletown	Connecticut
Yale Univ Digestive Diseases /ID# 141987	New Haven	Connecticut
Georgetown University Hospital /ID# 113437	Washington D.C.	District of Columbia
Brandon Premier Health Care, PA/Gulf Coast Research Group, LLC /ID# 148230	Brandon	Florida
Sarkis Clinical Trials /ID# 137948	Gainesville	Florida
Hollywood Research Center /Id# 214723	Hollywood	Florida
Ctr for Advanced Gastroenterol /ID# 116236	Maitland	Florida
Research Associates of South Florida,LLC /ID# 148212	Miami	Florida
Paradise Clnical Research, LLC /ID# 212027	Miami	Florida
Duplicate_Abel & Buchheim, P.R., Inc. /ID# 143863	Miami	Florida
Gastroenterology Group Naples /ID# 105837	Naples	Florida
Advanced Research Institute, Inc /ID# 211335	New Port Richey	Florida
Duplicate_North Florida Gastro Research /ID# 128538	Orange Park	Florida
Advent Health /ID# 145705	Orlando	Florida
Endoscopic Research, Inc. /ID# 136883	Orlando	Florida
Duplicate_Combined Research Orlando - Phase I-IV /ID# 141660	Orlando	Florida
Digestive Diseases Center /ID# 118116	Panama City	Florida

+ 472 more sites — see the full list on the official registry below.

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Other trials for the same condition

Integrated Clinical-Occupational Management for Workers With Chronic Noncommunicable Diseases Active, not recruiting

A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis Active, not recruiting

A Study to Evaluate the Long-Term Safety and Efficacy of Upadacitinib (ABT-494) in Participants With Ulcerative Colitis (UC) Active, not recruiting

LY4268989 in Adults With Moderately to Severely Active Ulcerative Colitis Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT01848561 on ClinicalTrials.gov ↗ ← All trials in Italy