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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT01848561
First received: May 3, 2013
Last updated: October 10, 2014
Last verified: October 2014
  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 Registry 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 8250
Study Start Date: April 2013
Estimated Study Completion Date: April 2027
Estimated Primary Completion Date: April 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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:

  1. For enrollment into the HUMIRA treatment group; adult patients with moderately to severely active UC who has been prescribed HUMIRA therapy according to the local product label 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
  2. 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
  3. Patients capable of and willing to grant authorization for use/disclosure of data being collected and provided to AbbVie and to comply with the requirements of the Registry protocol

Exclusion Criteria:

  1. Patients who can not be treated with HUMIRA in accordance with the local label or cannot be treated with IMM therapy.
  2. Patients who are being treated with any investigational agents and/or approved biologics other than Humira.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01848561

Contacts
Contact: Marilyn Wanca, BS 847-937-2375 marilyn.wanca@abbvie.com
Contact: Eva Perotti, BS 847-938-9243 eva.perotti@abbvie.com

  Show 416 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
Study Director: Andreas Lazar, MD AbbVie
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT01848561     History of Changes
Other Study ID Numbers: P11-282
Study First Received: May 3, 2013
Last Updated: October 10, 2014
Health Authority: United States: Food and Drug Administration
Denmark: Danish Dataprotection Agency
Norway: Norwegian Medicines Agency
Ireland: Research Ethics Committee
Germany: Paul-Ehrlich-Institut
France: French Data Protection Authority
Denmark: Danish Health and Medicines Authority
Spain: Agencia Española de Medicamentos y Productos Sanitarios
France: Conseil National de l'Ordre des Médecins
Croatia: Agency for Medicinal Product and Medical Devices
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Canada: Health Canada
Israel: Ethics Commission
Greece: National Organization of Medicines
Mexico: Ministry of Health
Belgium: Ethics Committee
Sweden: Regional Ethical Review Board
Greece: Ethics Committee
Austria: Federal Office for Safety in Health Care

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

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

ClinicalTrials.gov processed this record on October 29, 2014