A Long-Term Registry of Humira® (Adalimumab) in Subjects With Moderately to Severely Active Crohn's Disease (CD)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT00524537
First received: August 31, 2007
Last updated: July 24, 2014
Last verified: July 2014

August 31, 2007
July 24, 2014
September 2007
December 2015   (final data collection date for primary outcome measure)
The primary objective of this Registry study is to evaluate the long-term safety of adalimumab in CD subjects who are treated as recommended in the local product label. [ Time Frame: Up to Six Years of Treatment ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00524537 on ClinicalTrials.gov Archive Site
The secondary objective is to evaluate long-term effectiveness of adalimumab in CD subjects who are treated as recommended in the local product label. [ Time Frame: Up to Six years of Treatment ] [ Designated as safety issue: No ]
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A Long-Term Registry of Humira® (Adalimumab) in Subjects With Moderately to Severely Active Crohn's Disease (CD)
A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of HUMIRA® (Adalimumab) in Subjects With Moderately to Severely Active Crohn's Disease (CD)

The primary objective of this Registry study is to evaluate the long-term safety and effectiveness of adalimumab in CD subjects who are treated as recommended in the product label.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Crohn's patients who have been prescribed adalimumab according to the local label.

Crohn's Disease
Not Provided
Adalimumab (Humira) Treatment
Patients who are prescribed and treated with Adalimumab (Humira)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
5000
December 2015
December 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects who are newly prescribed HUMIRA® (adalimumab) therapy (have never been treated with adalimumab) or who are participants in Abbott sponsored investigational CD trials, are currently receiving adalimumab and for whom the treating physician has made the decision to continue with adalimumab therapy beyond the duration of the investigational trial.
  • Subjects who were participants in Abbott sponsored investigational Crohn's disease trials, who have not had dose interruptions since the last dose of study drug, where the Investigator can provide source documentation of dosing information.
  • Subjects who are currently receiving adalimumab, as per the local approved label, who have not had dose interruptions since the induction dose of adalimumab where the Investigator can provide source documentation of dosing information.
  • Subjects willing to consent to data being collected and provided to Abbott.
  • Subjects capable of and willing to give written informed consent and to comply with the requirements of the Registry study protocol.

Exclusion Criteria:

  • Subjects should not be enrolled if they cannot be treated in accordance with the local product label.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Belgium,   Canada,   Czech Republic,   Denmark,   France,   Germany,   Greece,   Hungary,   Iceland,   Ireland,   Italy,   Netherlands,   New Zealand,   Norway,   Portugal,   Slovakia,   Slovenia,   South Africa,   Spain,   Sweden,   United Kingdom
 
NCT00524537
P06-134
No
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Roopal B Thakkar, MD AbbVie
AbbVie
July 2014

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