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 April 2016 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT01848561
First received: May 3, 2013
Last updated: April 14, 2016
Last verified: April 2016

May 3, 2013
April 14, 2016
April 2013
April 2027   (final data collection date for primary outcome measure)
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 ]
Evaluation of long term safety of Adalimumab in patients with moderately to severely active UC [ Time Frame: Up to 10 years observational period ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01848561 on ClinicalTrials.gov Archive Site
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 ]
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: Up to 10 years observational period ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Long-Term Registry of Humira® (Adalimumab) in Patients With Moderately to Severely Active Ulcerative Colitis (UC)
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)
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
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.
Ulcerative Colitis
Not Provided
  • Adalimumab (Humira) Treatment
    Patients who are prescribed and treated with Adalimumab
  • Immunomodulatory Therapy
    Patients who are being prescribed and treated with Immunomodulatory Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
8250
April 2027
April 2027   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Marilyn Wanca, BS 847-937-2375 marilyn.wanca@abbvie.com
Contact: Eva Perotti, BS 847-938-9243 eva.perotti@abbvie.com
United States,   Austria,   Belgium,   Canada,   Croatia,   Denmark,   France,   Germany,   Greece,   Ireland,   Israel,   Italy,   Mexico,   Netherlands,   Norway,   Puerto Rico,   Spain,   Sweden,   United Kingdom
 
NCT01848561
P11-282
No
Not Provided
Not Provided
AbbVie
AbbVie
Not Provided
Study Director: Holly A Read, MD AbbVie
AbbVie
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP