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Trial record 1 of 1 for:    A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of HUMIRA? (Adalimumab) in Patients with Moderately to Severely Active Ulcerative Colitis (UC)
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A Long-Term Registry of Humira® (Adalimumab) in Patients With Moderately to Severely Active Ulcerative Colitis (UC)

This study is currently recruiting participants.
Verified October 2017 by AbbVie
Sponsor:
ClinicalTrials.gov Identifier:
NCT01848561
First Posted: May 7, 2013
Last Update Posted: October 11, 2017
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.
Information provided by (Responsible Party):
AbbVie
  Purpose
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
Ulcerative Colitis

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by AbbVie:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 8250
Study Start Date: April 29, 2013
Estimated Study Completion Date: April 26, 2027
Estimated Primary Completion Date: April 26, 2027 (Final data collection date for primary outcome measure)
Groups/Cohorts
Adalimumab (Humira) Treatment
Patients who are prescribed and treated with Adalimumab
Immunomodulatory Therapy
Patients who are being prescribed and treated with Immunomodulatory Therapy

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
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
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
Contact: Marilyn Wanca, BS 847-937-2375 marilyn.wanca@abbvie.com
Contact: Andreia Bornel, BS 561-249-2943 andreia.bornel@abbvie.com

  Show 601 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
Study Director: Graham Heap, MD AbbVie
  More Information

Additional Information:
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT01848561     History of Changes
Other Study ID Numbers: P11-282
First Submitted: May 3, 2013
First Posted: May 7, 2013
Last Update Posted: October 11, 2017
Last Verified: October 2017

Keywords provided by AbbVie:
Inflammatory Bowel Diseases
Gastroenteritis
Adalimumab
Ulcerative Colitis
Registry
Gastrointestinal Diseases
Colitis

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Adalimumab
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Anti-Inflammatory Agents
Antirheumatic Agents