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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Ulcerative Colitis (UC)

Participation Criteria
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Eligibility Criteria
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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: Is currently taking HUMIRA therapy and has received at least 8 weeks of therapy; OR 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Immunomodulatory Therapy<br>Patients who are being prescribed and treated with Immunomodulatory Therapy | |
| Adalimumab (Humira) Treatment<br>Patients who are prescribed and treated with Adalimumab | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of long term safety of Adalimumab in patients with moderately to severely active UC |  | 10 years observational period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ulcerative Colitis, Registry, Adalimumab, Colitis, Gastroenteritis, Inflammatory Bowel Diseases, Gastrointestinal Diseases