Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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: October 28, 2014
Last verified: October 2014
  Purpose

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.


Condition
Crohn's Disease

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 Subjects With Moderately to Severely Active Crohn's Disease (CD)

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 5000
Study Start Date: September 2007
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Adalimumab (Humira) Treatment
Patients who are prescribed and treated with Adalimumab (Humira)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.
  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: NCT00524537

  Show 426 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Roopal B Thakkar, MD AbbVie
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT00524537     History of Changes
Other Study ID Numbers: P06-134
Study First Received: August 31, 2007
Last Updated: October 28, 2014
Health Authority: Slovakia: State Institute for Drug Control
Canada: Health Canada
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Iceland: Icelandic Medicines Control Agency
Denmark: Danish Medicines Agency
Sweden: Medical Products Agency
Portugal: National Pharmacy and Medicines Institute
Hungary: National Institute of Pharmacy
Italy: The Italian Medicines Agency
Germany: Paul-Ehrlich-Institut
Norway: Norwegian Medicines Agency
Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Agency for Health and Food Safety
Ireland: Irish Medicines Board
South Africa: Medicines Control Council
New Zealand: Medsafe
Czech Republic: State Institute for Drug Control
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
United States: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Slovenia: Agency for Medicinal Products - Ministry of Health
Greece: Ministry of Health and Welfare
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by AbbVie:
Crohn's Disease

Additional relevant MeSH terms:
Crohn Disease
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014