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

ID#: NCT01848561

Age: 18 - 99 years

Gender: All

Healthy Subjects: No

Recruitment Status: Recruiting

Start Date: April 29, 2013

End Date: April 26, 2027

Contact Information:
Malia Bizzell
1-770-755-6749
Andreia Bornel, BS
561-249-2943
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:

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.