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

AbbVie

Status

Active, not recruiting

Conditions

Ulcerative Colitis (UC)

Study type

Observational

Funder types

Industry

Identifiers

NCT01848561

P11-282

Details and patient eligibility

About

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.

Enrollment

8,250 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

No 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.