A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of HUMIRA® (Adalimumab) in Patients with Moderately to Severely Active Ulcerative Colitis (UC)

  • STATUS
    Recruiting
  • sponsor
    AbbVie
Updated on 8 November 2020

Summary

A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of HUMIRA® (Adalimumab) in Patients with Moderately to Severely Active Ulcerative Colitis (UC)

Description

This Ulcerative Colitis Registry study is for Patients with Moderately to Severely Active Ulcerative Colitis and currently taking HUMIRA (Adalimumab) therapy.

Details
Condition Ulcerative Colitis
Clinical Study IdentifierTX138405
SponsorAbbVie
Last Modified on8 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Male and Female, 18 years and older
Diagnosis of moderate to severe Ulcerative Colitis
Currently taking HUMIRA therapy, and has received at least 8 weeks of HUMIRA therapy prior to registry entry
For a patient enrolling into the IMM treatment group with moderate to severe active UC as per the physician’s assessment who has been prescribed IMM (6-mercapopurine or azathioprine) therapy, is currently taking IMM therapy, has received at least 12 consecutive weeks of IMM therapy prior to registry entry and the physician can provide source documentation

Exclusion Criteria

Patients that cannot be treated with Humira in accordance with the local product label
Patients that cannot be treated with IMM therapy
Patients should not be enrolled into the IMM treatment group if they require ongoing treatment with approved biologic agents including HUMIRA (adalimumab) or any investigational agents
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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