Details for the study
Population
Adult patients with moderately to severely active Ulcerative Colitis (UC) who have been
prescribed HUMIRA according to the local label and adult patients being prescribed and
treated with IMM (6-mercaptopurine or azathioprine) with no concurrent biologic use.
Brief Title
A Long-Term Registry of Humira® (Adalimumab) in Patients With Moderately to Severely Active Ulcerative Colitis (UC)
Official Title
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)
Brief Summary
This is a registry study to evaluate the long-term safety and effectiveness of adalimumab in
<br /> patients with moderately to severely active UC who are treated as recommended in the product
<br /> label.
Study Criteria
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.