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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01848561
Recruitment Status : Recruiting
First Posted : May 7, 2013
Last Update Posted : December 19, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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Brief 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.

Condition or disease
Ulcerative Colitis (UC)

Study Design
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Study Type : Observational
Estimated Enrollment : 5450 participants
Observational Model: Cohort
Time Perspective: Prospective
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)
Actual Study Start Date : April 29, 2013
Estimated Primary Completion Date : April 6, 2027
Estimated Study Completion Date : April 6, 2027

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

Groups and Cohorts
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Group/Cohort
Immunomodulatory Therapy
Patients who are being prescribed and treated with Immunomodulatory Therapy
Adalimumab (Humira) Treatment
Patients who are prescribed and treated with Adalimumab


Outcome Measures
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Primary Outcome Measures :
  1. Evaluation of long term safety of Adalimumab in patients with moderately to severely active UC [ Time Frame: 10 years observational period ]

Secondary Outcome Measures :
  1. Evaluation of long term effectiveness of Adalimumab in patients with moderately to severely active UC who have had an inadequate response to conventional therapy [ Time Frame: 10 years observational period ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01848561


Contacts
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Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com
Contact: Andreia Bornel andreia.bornel@abbvie.com

Locations
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Sponsors and Collaborators
AbbVie
Investigators
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Study Director: AbbVie Inc. AbbVie
More Information
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Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT01848561    
Other Study ID Numbers: P11-282
First Posted: May 7, 2013    Key Record Dates
Last Update Posted: December 19, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AbbVie:
Ulcerative Colitis
Registry
Adalimumab
Colitis
 Gastroenteritis
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
 Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents