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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)

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 : September 18, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date May 3, 2013
First Posted Date May 7, 2013
Last Update Posted Date September 18, 2019
Actual Study Start Date April 29, 2013
Estimated Primary Completion Date April 6, 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 25, 2014)
Evaluation of long term safety of Adalimumab in patients with moderately to severely active UC [ Time Frame: 10 years observational period ]
Original Primary Outcome Measures
 (submitted: May 3, 2013)
Evaluation of long term safety of Adalimumab in patients with moderately to severely active UC [ Time Frame: Up to 10 years observational period ]
Change History Complete list of historical versions of study NCT01848561 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: July 25, 2014)
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 ]
Original Secondary Outcome Measures
 (submitted: May 3, 2013)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Long-Term Registry of Humira® (Adalimumab) in Patients With Moderately to Severely Active Ulcerative Colitis (UC)
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)
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Ulcerative Colitis (UC)
Intervention Not Provided
Study Groups/Cohorts
  • Immunomodulatory Therapy
    Patients who are being prescribed and treated with Immunomodulatory Therapy
  • Adalimumab (Humira) Treatment
    Patients who are prescribed and treated with Adalimumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 3, 2013)
8250
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 6, 2027
Estimated Primary Completion Date April 6, 2027   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com
Contact: Patient Recruitment patientrecruitment@abbvie.com
Listed Location Countries American Samoa,   Australia,   Austria,   Belgium,   Canada,   Croatia,   Denmark,   France,   Germany,   Greece,   Ireland,   Israel,   Italy,   Mexico,   Netherlands,   New Zealand,   Norway,   Puerto Rico,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01848561
Other Study ID Numbers P11-282
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party AbbVie
Study Sponsor AbbVie
Collaborators Not Provided
Investigators
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date September 2019