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

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)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01848561

Acronym

LEGACY

Enrollment

8250

Registered

2013-05-07

Start date

2013-04-29

Completion date

2028-06-30

Last updated

2025-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis (UC)

Keywords

Ulcerative Colitis, Registry, Adalimumab, Colitis, Gastroenteritis, Inflammatory Bowel Diseases, Gastrointestinal Diseases

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

Australia, Austria, Belgium, Canada, Croatia, Denmark, France, Germany, Greece, Ireland, Israel, Italy, Mexico, Netherlands, New Zealand, Norway, Puerto Rico, Spain, Sweden, United Kingdom, United States

Outcome results